Final Writ-DR - ANIRUDDHA NARAYAN

IN THE SUPREME COURT OF INDIA
CIVIL ORIGINAL JURISDICTION
WRIT PETITION NO._________ OF 2022
[A Writ Petition under Article 32 of the Constitution of India for
Enforcement of Fundamental Rights Guaranteed Under Part-III
of The Constitution]
IN THE MATTER OF:
DR.ANIRUDDHA NARAYAN
MALPANI & ORS. …. PETITIONERS
//VERSUS//
UNION OF INDIA & ORS. …. RESPONDENTS
PAPER BOOK
[KINDLY SEE INDEX INSIDE]
ADVOCATE FOR THE PETITIONERS: MS. MOHINI PRIYA

INDEX
Sl. Particulars of Document Page No. of part to Remarks

No. which it belongs
Part I Part II
(Comments (Comm
of Paper ents of
Book) file
alone)
(iii) (iv) (v)

(i) COURT FEES Rs.
1. O/R on Limitation
2. Listing Proforma A1- A2
3. Cover Page of Paper Book A-3
4. Index of Record of A-4
Proceedings
5. Limitation Report A-5
prepared by the Registry
6. Defect List A-6
7. Note Sheet NSL ..
8. List of Dates B-P
9. Writ Petition with affidavit 1-105
10. Annexure P/1 106-115
A true copy of the
Convention on the
Elimination of all Forms of
Discrimination Against
Women adopted by the
United Nations General
Assembly on 18.12.1979.
11. Annexure P/2 116-131
A copy of the survey
report.
12. Annexure P/3 132-156
A copy of the research
paper published by
American Society for
Assisted Reproductive
Technology.
13. Annexure P/4 157-289
A true copy of National
Guidelines for
Accreditation,
Supervision and
Regulation of ART Clinics
in India, 2005.
14. F/M 290
15. Vakalatnama 291-507
A/1
LISTING PROFORMA
SECTION:X
The case pertains to:
• Central Act (Title) : Under Article 32 of the
Constitution of India
• Section : N.A.
• Central Rule (Title) : N.A.
• Rule No(s). : N.A.
• State Act (Title) : N.A.
• Section : N.A.
• State Rule (Title) : N.A.
• Rule No(s). : N.A.
• Impugned Interim Order (Date) : N.A.
• Impugned Final Order / Decree (Date) : N.A.
• High Court (Name) : N.A.
• Name of Judges : N.A.
• Tribunal / Authority (Name) : N.A.
Nature of the matter : Civil
1.
2. (a) Petitioner / Appellant No.1 : DR.ANIRUDDHA NARAYAN
MALPANI & ORS.
(b) Email I.D. : N.A.
(c) Mobile phone number : N.A.
3. (a) Respondent No.1 : UNION OF INDIA & ORS.
(b) Email I.D. : N.A.

(c) Mobile phone number : N.A.
4. (a) Main category classification :
(b) Sub-classification : Others
5. Not to be listed before :
A/2
6. (a) Similar disposed of matter with : No similar matter disposed of
citation, if any, & case details
(b) Similar pending matter with case : No similar matter is pending
details
7. Criminal Matters: NO
(a) Whether accused / convict has : N.A.
surrendered
(b) FIR No. : N.A

Date : N.A
(c) Police Station : N.A
(d) Sentence Awarded : N.A
(e) Period of sentence undergone : N.A
including period of detention /
custody undergone
8. Land Acquisitions Matters: Yes
(a) Date of Section 4 notification : N.A.
(b) Date of Section 6 notification : N.A.
(c) Date of Section 17 notification : N.A.
9. Tax matters:
State the tax effect : N.A.
10. Special Category : • Senior citizen > 65 years
(first Petitioner / Appellant only) • SC / ST
• Woman / Child
• Disabled
• Legal Aid case
• In custody
11. Vehicle Number (in cases of Motor : N.A.
Accident Claim matters)
Filed by
[MS.MOHINI PRIYA]
Filed on : 03.12.2022 Advocate for the petitioners
B
SYNOPSIS
The present writ petition has been filed by a group of doctors
invoking the extraordinary jurisdiction of this Hon’ble Court
under Article 32 of the Constitution praying to this Hon’ble
Court to strike down the unconstitutional, arbitrary,
unreasonable and unscientific provisions introduced by the
Assisted Reproductive Technique (Regulation) Act, 2021
(hereinafter referred to as the “ART Act”) alongwith the
Assisted Reproductive Techniques(Clinic) Rules, 2022
(hereinafter referred to as the ART Rules), which together have
brought about a repressive and discriminatory regime which in
denial of reproductive autonomy of women. The specific
provisions under are Section 21(b) r/w Rule 3, Section 21(g),
Section 22(1)(b), Section 27(1), Section 27(4), Section 29 and
Section 33 of the ART Act.
That the Petitioners herein seek indulgence of this Hon’ble
Court under Article 32 of the Constitution for the rights of egg
donors and childless couples which as part of doctor-patient
relationship they are duty bound to protect as well as rights of
medical practitioners, primarily on the following grounds:

C
(i) The Act is discriminatory and unconstitutional apart from
being in derogation of International Best Practices and
ICMR Guidelines of 2010 for IVF clinics;
(ii) The Act imposes unreasonable restrictions on egg donors
which are unscientific and in violation of reproductive
autonomy of women;
(iii) Lack of any provision for monetary consideration for
oocyte donors is violative of their right to life;
(iv) Complete ban on embryo transfer and lack of transitory
provisions for embryos frozen prior to the enforcement
of the Act is creating difficulties for childless couples
desirous of availing ART services;
(v) Arbitrary age restrictions for couples desirous of availing
ART processes through donor eggs is violative of
reproductive rights of women;
(vi) Mandatory collection of donor gametes by an ART Bank
instead of an ART Clinic makes the process cumbersome
and expensive;
D
(vii) Exclusion of live-in couples, same sex couples and single
men from availing ART Services;
(viii) Bringing medical practitioners under the rigours of the
Indian Penal Code, 1860 by providing stringent penalties
and imprisonment for contravention of the Act is
unreasonable and violative of Article 19 and 21 of the
Constitution;
The statement of objects and reasons of the ART Act states
as follows:
“An Act for the regulation and supervision of the
assisted reproductive technology clinics and the assisted
reproductive technology banks, prevention of misuse,
safe and ethical practice of assisted reproductive
technology services for addressing the issues of
reproductive health where assisted reproductive
technology is required for becoming a parent or for
freezing gametes, embryos, embryonic tissues for further
use due to infertility, disease or social or medical
concerns and for regulation and supervision of research

E
and development and for matters connected therewith or
incidental thereto.”
That while the intent of the legislature behind framing of
the Assisted Reproductive Techniques Act, 2021 is to prevent
misuse and promote safe and ethical practices for addressing
issues of reproductive health, it is pertinent to mention here that
in the drafting of the ART Bill, 2021, no members of the scientific
committee were invited for their proposals and suggestions.
Resultantly, the provisions under challenge in the ART Act, 2021
are without any scientific basis a specially in a field which
requires medical and scientific knowledge and expertise for its
proper implementation. Several provisions of the Act have been
mindlessly drafted without including any members of the
scientific committee in the drafting process. Moreover, the
restrictions imposed by way of the Act are nowhere in
consonance with the statement of object and reasons of the Act.
At the outset it is humbly submitted that one of the crucial
oversights of the ART Act is its failure to fully address the rights
of donors, especially egg donors. The Act does not provide for
F
any monetary consideration for the loss of time, loss of job,
transportation and physical and mental health risk components,
which is highly unreasonable and unjustified and in derogation
of international best practices.It is submitted that the ART Act
under Section 22 provides for insurance coverage for egg
donors for 12 months and social security insurance, the
parameters of which are not clear. However, beyond these
recommendations, there is no provision for donor consideration
or even the reimbursement of expenses for loss of salary, time
and effort, even though there is no provision in the ART Act
which specifically debars such monetary consideration either,
thus making it open to judicial scrutiny. Further, while the
commissioning couples gets a child and the doctors get their
professional fees, it is the egg donors whose rights have not
been sufficiently addressed making the Act falls foul of Articles
14 and 19 and 21 of the Constitution.
It is submitted that the lack of monetary consideration will
lead to shortage of egg donors who are willing to go through
the procedure without any benefits, leading to shortage of
donor eggs and a consequent rise in cost of donor eggs.

G
Further, Section 2 (1) (e) of the Act defines "commissioning
couple" as an infertile married couple who approach an
assisted reproductive technology clinic or assisted
reproductive technology bank for obtaining the services
authorised of the said clinic or bank. The definition of a
commissioning couple under the ART Act does not require
them to have an Indian origin, which means there is no bar on
foreign commissioning couples to avail ART services, thereby
allowing the government to benefit from international medical
services. This is likely to increase demand for ART services
and drive up the prices, as foreign commissioning couples
arguably have the resources to bear high costs of availing IVF
processes. Meanwhile, the Act requires the IVF sector to rely
on the altruism of gamete donors, which will reduce the supply
of gametes, thereby producing a shortage in gamete supply.
This will result in higher prices for gametes, which is highly
likely to incentivise an underground market in gametes. This
would also mean that only the wealthiest can access ARTs
excluding millions from non-elite socio-economic groups who
aspire to form families. Meanwhile, egg donors will continue to
be devalued, uncompensated and unprotected as

H
underground markets for egg donors and surrogacy thrive.
Thus the altruistic nature of egg donation is counterproductive,
creates an artificial distinction between childless couple on the
basis of their economic status and violative of the reproductive
rights of women under Article 14 and 21 of the constitution.
It is further submitted that the ART sector is much larger
than the surrogacy sector. Surrogacy necessarily implicates the
use of ARTs given that only gestational surrogacy is permitted
and the woman acting as a surrogate cannot contribute her
gametes. On the other hand, the use of ARTs need not implicate
surrogacy (for example, a couple may use their own gametes
for in-vitro fertilisation [IVF] with the woman carrying the baby).
Even the most successful of surrogacy clinics have delivered
only a few thousand babies, whereas there are 27 million
infertile couples in India today and an estimated two lakh cycles
of IVF undertaken each year (Sharma 2018; Murdia 2020). In
these circumstances, applying the restrictive and perverse
logic of Surrogacy (Regulation) Act, 2021 to the ART Act, 2021
by not allowing compensation for oocyte donors is completely
irrational and unjustified.

I
The Act under the provision of Sections 27(4) allows
gamete donors to donate only once in their lifetime. It is
submitted that such restriction specially as regards oocyte
donors under Section 27(4) is not only medically impossible to
implement and will result in wastage and consequential
shortage of donor eggs leading to exorbitant rise in cost of
obtaining donor eggs, taking ART process outside the reach of
the economically weaker sections.
It is submitted that in current practice, especially with the
long waiting and difficulties with adoption, embryo donation
remains one of the most cost effective and successful
modalities of treating couples who have failed IVF or cannot
afford repeated cycles. There would be a great increase in
treatment costs and huge shortage of donors if an oocyte donor
is allowed to donate only once. Moreover there is no scientific
basis for allowing only one oocyte donation as against six
which were allowed as per ICMR guidelines. This restriction
would put IVF with oocyte donation (which is required by
almost 40% of patients in any IVF clinic) out of reach of the
entire middle and lower income group of patients (there would

J
be almost 1.5-2 Crore patients who require egg donation at a
reasonable and affordable budget). Thus the aforesaid
provisions apart from infringing the reproductive autonomy
of women also create an artificial distinction between
childless couples on the basis of their economic status,
making it violative of Article 14 of the Constitution.
That Section 21(g) of the Act prescribes age limit for couples
commissioning IVF. The age restrictions imposed upon
commissioning couples by the State is absolutely irrational and
arbitrary, especially when using third party eggs for
conception. If the third party donor eggs are healthy then there
is no rationale for imposing a restriction on age for women to
commission ART services. According to The Indian Council of
Medical Research (ICMR) guidelines of 2005, the woman
carrying the baby “should be a healthy woman (determined by
medical and psychological examination) having normal genitalia
(as determined by physical examination)…”. Therefore, the
restriction on age of commissioning couples under the ART Act
is contrary to the guidelines of 2005 of ICMR which is a
specialized body which issued these guidelines taking note of

K
ground realities. In fact such decision should be left solely to the
discretion of the IVF practitioner after assessing the health
condition of the woman instead of the legislature getting into the
technicalities of a specialized field like IVF. Moreover, such
restriction is against the reproductive autonomy of women
which has been upheld by this Hon’ble Court in a catena of
judgments and most recently in X vs. Principal Secretary, Health
and Family Welfare, Government of NCT of Delhi and Anr., 2022
SCC Online SC 905.
Moreover, although Section 21(1)(e) the ART Act allows single
women to avail ART processes, it completely side steps same-
sex couples and live-in couples from availing ART services,
making it violative of Articles 14 and 21 of the Constitution.
It is further submitted that a complete prohibition on embryo
transfer under Section 29 of the ART Act has made it impossible
for couples to avail ART Services in cases where donor embryos
have been frozen prior to the passing of the ART Act. In the
absence of transitory provisions and in the absence of setting up
State Boards in most states of India, commissioning couples are

L
facing huge difficulties in procuring such frozen embryos for
continuation of IVF procedures. The intention of the legislature
is to prevent/restrict sale of human gametes but such blanket
ban on embryo transfer is causing unnecessary difficulties for
commissioning couples in availing ART services which is
neither desirable not in consonance with the object sought to be
achieved by the Act.
It is humbly submitted that although the object of the
legislature is to streamline the process of Assisted
Reproduction, the mandatory provision of gamete collection by
an ART Bank makes the entire process of obtaining donor
gametes more onerous, complicated and expensive and serves
no useful purpose. Moreover, no such ART banks have been
approved till date, which is making it impossible for clinics to
carry out donor gamete collection despite having the available
donors, due to the procedural obstruction created by insertion
of Section 21(b) of the ART Act alongwith Rule 3. This is
resulting in many hospitals and ART Clinics refusing to carry out

M
donor cycles, adding to the miseries and woes of
commissioning couples.
Furthermore, one of the glaring flaws in the ART Act is that it
brings medical practitioners under the rigours of the Indian
Penal Code by imposing strict penalties as well as
imprisonment for contravention of the conditions prescribed
under Section 33 of the Act and further classifying the offences
as cognizable. This additional punitive provision is completely
draconian and unreasonable considering medical professionals
are already under the purview of National Medical Commission,
Consumer courts and Civil Courts. Further this has had a
chilling effect on IVF practitioners all over the country,
deterring them from undertaking IVF procedures, which is
further adding to the miseries and woes of childless couples.
That this Hon’ble Court in the judgment of X vs. Principal
Secretary(supra) has made certain glaring observations as
regards the cascading effects of fear of prosecution amongst
registered medical practitioners. The relevant extract is quoted
hereinbelow:
N
“20. …….A fear of prosecution under this complex
labyrinth of laws, including linking of the MTP (Medical
Termination of Pregnancy) Act with the IPC (Indian Penal
Code), acts as a major barrier to safe abortion access, by
having a chilling effect on the behaviour of RMPs
(Registered Medical Practitioners). The chilling effect —
historically associated with protection of freedom of
speech and expression under Article19— has an impact on
the decision-making of medical professionals acting under
the MTP Act and consequently impedes access to safe and
legal abortions and the actualization of women’s
fundamental right to reproductive autonomy.”
Hence, the present Writ Petition.
LIST OF DATES
DATES PARTICULARS
O
10.12.1948 THE General Assembly of the United Nations
adopted the Universal Declaration ofHuman
Rights(UDHR). That Article 12 of the Universal
Declaration of Human Rights, to which India is
a signatory, states that no one shall be
subject to arbitrary interference with his/her
privacy family, home or correspondence nor
to attacks upon his/her honor and reputation.
16.12.1966 The General Assembly of the United
Nations adopted the International Covenant
on Civil and Political Rights(ICCPR).
03.10.1978 Ms. Kanupriya Agarwal @Durga was born in
Kolkata, India and is widely regarded as the
world’s second test tube baby.
18.12.1979 The General Assembly of the United Nations
adopted the Convention on the Elimination of all
Forms of Discrimination Against Women
(CEDAW).
06.08.1986
India’s first scientifically documented IVF baby,
P
Harsha, was born in Mumbai, through the
collaborative efforts of the Institute for Research
in Reproduction of the Indian Council for
Medical Research (ICMR) and the King Edward
Memorial Hospital (KEM), Mumbai.
2005 The ICMR and NAMS issued the National
Guidelines for Accreditation, Supervision and
Regulation of ART Clinics in India. Bereft of
any other guidelines or statute governing
the field of surrogacy and or Assisted
Reproductive Technology (ART),the said
guide lines became the defacto rules in the
said sphere.
25.01.2022. The Assisted Reproductive Technology
(Regulation) Act, 2021 (here in after
referred to as the “Art Act”)
07.06.2022 The Assisted Reproductive Technology
Rules, 2022 came into force.
03.12.2022 Hence the Writ Petition

1
CIVIL ORIGINAL JURISDICTION
WRIT PETITION NO._________ OF 2022
[A Writ Petition under Article 32 of the Constitution of India for
Enforcement of Fundamental Rights Guaranteed Under Part-III
of The Constitution]
IN THE MATTER OF:
1. Aniruddha Narayan Malpani

S/o. Narayan Malpani
R/o. Flat No. 604, Jamuna Sagar,
6th Floor, Shahid Bhagat Singh Road,
Colaba Bus Station, Colaba, Mubai-400005
(Maharashtra)
2. Dr R Balakrishnan
R/o. 46/985, Chettupuzha P.O. Manakody,
Thrissur – 680012
Kerala
3. G. Anusha
D/O: Krishnachary,
R/o. 8-56/2, Near Post Office,
Ghatkesar, Ghatkesar, Ghatkesar,
K.V. Rangareddy,
Andhra Pradesh – 501301
4. Raj Gopal Achary

S/o Gour Raju Achary,
R/o. 75-6-18, Prakash Nagar,
Main Road, Pragathi Hospital,
Prakash Nagar, Rajamahendravaram (Urban),
2
East Godavari, Andhra Pradesh 533 103
5. Dr. Sudakshina Panja

R/o. 92, Bahir Sarbamagala Road, Barddhaman,
Bahir Sarbamangala (P). Budhaman– 713101
West Bengal
6. Dr. Sanjay Shukla

R/o. B-305, Mahima Panorama,
Jagatpura, Jaipur, Jaipur- 302017
Rajasthan
7. Renu Jain
W/o Dr. Sharvesh Sharan Joshi,
R/o. E 553/554, Muralipura Scheme,
Sikar Road Jaipur, Amber, Amer,
Jaipur- 302 028
Rajasthan
8. Dr G Kasturi
W/O Jayadev B.
R/o. # 140, 3rd Cross 2ND Stage AGB Layout,
Mahalakshmi Puram, Bangalore,
Mahalakshmipuram Layout, Bangalore
Karnataka, 580088
9. Charudutt Joshi
S/o Sudhakar Joshi,
R/o. J Sectore Gardan Ke Samne,
J/47 L.I.G colony, Indore-452 011
Madhya Pradesh
10. Dr. Anuj Sharma

R/o. L-5 Shashtri Nagar,
Medical PO.A. Meerut,
L.L.R.M. Med College,
Meerut-250004, Uttar Pradesh
11. Dr. Sweety Soni

W/o Naresh Kumar Soni,
R/o. 81, Suraj Path , Keshav Vihar,
Behind riddhi siddhi Sweets,
3
Gopal Pura Bye Pass Road, Jaipur-302 018
Rajasthan
12. Muhammed Asif

S/o, R Ummarabba,
R/o. Delta Gate, Flat No:302,
Balmatta, Opp Shanthi, Nilaya Hall Baimatta,
Mangalore,, Dakshina Kannada,
Karnataka – 575001
13. Mangalam Raman

W/o Mouleeswaran,
R/o. 401, Block-37A,
Bollineni Hillside Nookampalayam
Sittalapakkam Kancheepuram- 600 125
Tamil Nadu
14. Dr. Gayatri Uttur

C/o: Amoghavarsha Vitthal
Raddi Udagatti, # 3-12-117/10,
Bus Stop Road, Raichur- 584 101
Karnataka
15. Arshi Iqbal

W/o Dr.Mohammed Iqbal
R/o. Chambai Garden Main Road 101,
Shakti Nagar Kota -324 009
Rajasthan
16. Dr. Gunjan Jain

W/o Sanjay Jain
R/o. A-247 Guru Jambeshwar Nagar Gandhi Path
Vaishali Nagar, Jaipur- 302 021
Rajasthan
17. Itishree
D/o Antaryami Nayak,
C/o Antaryami Nayak, Madhabandha,
Sadar, Sambalpur- 768 003
Odisha
18. Dr.Jeyamithra
4
W/o. Anandkumar,
R/o. Plot.No-764, Palanichamy
Illam Aringar Anna Nagar,
M I G Colony, Anna Nagar,
Andarkottaram, Madurai- 625 020
Tamil Nadu
19. Dr Vani Sundarapandian

W/o: Selvamuthu Kumarasamy,
R/o. NO:22/10, 11, Kazura Garden,
1st Street, Neelankarai, Injambakkam,
Kancheepuram - 600 115
Tamil Nadu
20. Shajila
D/o Samtitus
R/o. 21/31A, Vineyard Hills,
Poovankananvilai Vilavancode,
Kanniyakumari- 629 155
Tamil Nadu
21. Neena Viswambharan

W/o Kiran P J Karuparambil
R/o. House Cherpalcheri PO Cherpulasseri,
Ottappalam, Palakkad- 679 503
Kerala
22. Dr Jansi Vanitha

W/o. Satyanarayanan Asokan,
R/o. B-502, Umiya Solloiluda,
Allo Dabonin, Near Mde college Zuarinagar,
South Goa, Goa 403 728
Maharashtra
23. Dr Kirti
W/o Divesh Goyal,
R/o. 570, Pujari Ka Mohalla,
Teh. Kotkasim, Harsoli, Harsoli,
Alwar-301403
Rajasthan
24. Dr. Sourav Bhuin

5
S/o. Sasthi Charan Bhuin,
Ghatak Para, Ghatak Par, Bankura,
Bankura (M),Bankura- 722101
West Bengal
25. Tania Banu

D/o Syed Talif Ali,
R/o. Sepoy Bazar, Medinipur(M),
Paschim Medinipur, Midnapore- 721101
West Bengal
26. Dr. Gunapathi

R/o. Tinsid Road Olnam Lesrak,
Khurai Sajor Leikai, Imphal East,
Manipur – 295010
27. Dr. Manjunath Navi

C/o Babu Navi
#46 Bhimashankar Layout Sindagi
Sindgi Vijayapura- 5786 128
Karnataka
28. Dr. Chandana

D/o V Naga Malleswara R
R/o. 29-14-32 Flat No 105
Sowbhagya Heights, Prakasam Road,
Suryaraopet, Vijayawada (Urban),
Buckinghampet, Krishnam
Andhra Pradesh 520 002
29. Arshi Babbar

D/o: Manish Babbar,
R/o Fourt Road, Near Nagar Prisad,
Hanumangarh Town,
Hanumangarh – 335513
Rajashtan
30. Dr. Rekha Rajendrakumar

W/o. H N Rajendra Kumar
R/o. #54 4th Cross 4th Main NGEF Layout
Nrupathuganagar Nagarbhavi
Bangalore-560 072
6
Karnataka
31. Fyzullah Syed

C/o Syed Rahamthulla,
R/o. No E 263, 2nd Floor,
D S Max Savera, Behind Rajathadri Hotel,
Uttarahalli, Chikkalasandra, Bengaluru- 560 061
Karnataka
32. Mohammed Akmal

S/o Mohammed Khaleel Ahmed
R/o. 23-1-943, Mulapet Near Little Angles School
Nellore Dargamitta
Nellore -524 003
Andhra Pradesh
33. Shilpa Haresh

C/o Flat No B 1903,
Mahendra Life Spaces
Wind Chimes Apartment,
Bannerghatta Road Arekere
Opp B P L Bangalore South Bannerghatta Road
Bengaluru- 560 076 Karnataka
34. Uma Maheshwari Sudhararaj

W/o. A Manikantan
R/o. T1B 2201, Mahindra winchimes,
Bannerghatta Road,
Opp. BPL Medical Technologies,
37/2A, Arekere, Bangaluru South,
Bangaluru-560076
Karnataka
35. Dr Manjunath
S/o Swamy C,
R/o. # 38, D Main Road, East End,
Jayanagar 9th Block, Bangalore south,
Bangalore- 560 069
Karnataka
36. Vani Pujari

C/o Radhakrishna,
7
R/o. 404,405, Sumithra Apartment,
Cherry Road, VTC: Hasthampatti,
PO: Hasthampatti, Sub District: Salem,
District: Salem -636 007
Tamil Nadu
37. Yazhini Selvaraj

W/o: Selvaraj,
R/o. 2/408, Pillaiyar Kovil Street,
Bank Colony Bus Stop, Thiruppalaio,
Madurai, Ma Reserve Lines,
Tamil Nadu – 625014
38. Monisha
R/o. Jayanagar, 26,
Pattalamma Temple Rd,
Basavanagudi, Bengaluru,
Karnataka 560004
39. Mangala Devi

W/o Udhaya Shankar
S/o. M V # 41 4th Cross CMR Lane
Lingarajapuram Bangalore St Thamos
Town Bangalore
Karnataka 560 084
40. Dr. Manu Lakshmi

R/o. 3/19, Kottur Garden
2nd Main Road, Kotturpuram,
Chennai– 600085
Tamil Nadu
41. Dr. Prasenjit Kumar Roy

C/o Late Abhoy Kumar Roy,
R/o. Flat-3B, Tower-1, Upwan Complex,
Uttorayan, Matigara, City Centre,
Gaurcharan, Matigara, Darjeeling-734010
West Bengal
42. Dr.Reeta Biliangady

W/o: Dr. Biliangady Harsha N,
R/o. #95 Mani, 3rd Main,
8
Opposite to M K Ahmed, Dollar Layout
J P Nagar, 4th phase, Bangalore South,
Bangalore-560078
Karnataka
43. Vengala Rao

R/o. P. Kandrika, Ponguru,
Nellore, Andhra Pradesh 524 302
44. Dr. Prasanthi Kakkera

W/o: Maddukuri Ravi Sarkar
R/o. 21-1-5 Society Road
Beside Sudha Hospital Tanuku
Tanuku West Godavari – 534211
Andhra Pradesh
45. Anupam Gupta

S/o. Amar Nath Gupta,
R/o. 2/37 Ram Nagar colony,
Civil Line S.O, Agra – 282002
Uttar Pradesh
46. Dr Yogitha
W/o Dr. Sanjay H R,
R/o. #88/2 T Narasipura Main Road,
Kasaba Hobli, Mysore- 570 028
Karnataka
47. Dr.S.K.Sreekumar
S/o Kunju Panocler
R/o. # 401, 7th Main 7th Cross
4th Block Koramangaia, Bangalore
Bangalore-560 034
Karnataka
48. Dr Asha S Vijay

W/o: S Vijay Kumar,
R/o.#578, 15th Main, New 1st A Main,
Near Maruthi Circle, BSK 1st Stage,
1st Block, Bangalore South, Banashankari,
Bangalore – 560050
Karnataka
9
49. Dr. V.N. Shivanagutti
C/o Bingappa,
R/o. Suviksha, Plot No 93,
Chandragiri Layout
Near Rajeevnagar Police Quaters,
Vidyanagar, VTC: Hubli,
PO; Hubli Udyamnagar,
Sub District: Hubli, District: Dharwad- 580 030
Karnataka
50. Dr. Sushma

C/o Vishwanath,
Suviksha, Plot No 93,
Chandragiri Layout
Near Rajeevnagar Police Quaters,
Vidyanagar, VTC: Hubli,
PO; Hubli Udyamnagar,
Sub District: Hubli, District: Dharwad- 580 030
Karnataka
51. Dr.J.Deepa Krishnan

W/o Krishnan,
R/o. 38, East Ramakrishnapuram,
Karur- 639 001
Tamil Nadu
52. Dr. Namita Kotia

W/o: Dr Amit Kotia,
R/o. 492, Gulab Enclave, C-123,
Dayanad Marg, Jaipur, Jawahar Nagat,
AC, Jobner, Jaipuer- 302004
Rajasthan
53. Dr. Hemant Chakarwarti

S/o A.K.Chakrawati,
R/o. E-21170. Chitrakoot Scheme,
Ajmer Road, Vaishali Nagar,
Jaipur, Vaishali Nagar-302021
Rajasthan
54. Dr.Sathya Balasubramanyam

S/o Balasubramanyam,
10
R/o. 402 B Walnut, Prince Greenwoods Apartment,
66 Vangaram Road, Ambattur,
Athipattu, Tiruvallur– 600058
Tamil Nadu
55. Dr. Babita John

C/o John Jeevaraj,
R/o.1/3F. Ram Maris Apartment,
Iyappan Kovil, Cantonment,
Tiruchirappalii – 620001
Tamil Nadu
56. Dr Praveena Ragunanthan

W/o: Ragunanthan Narayanaswamy,
R/o. Door No 5, Block X, 5th Street,
Anna Nagar, Anna Nagar, Chennai – 600040
Tamil Nadu
57. Divya Agrawal

W/o: Amitabh Agrawal,
R/o. B 37/54 A-7, 6, Giri Nagar,
Birdopur, Chhitupur, Varanasi – 221010
Uttar Pradesh
58. Dr. Geeta Bharat

C/o. Bharat S R,
Sarvodaya Womens Hospital And
Fertility Centre, Near Police Training School,
Girinagar, VTC: Dharwad,
PO: Dharwad Saraswatpur,
Sub district: Hubli, District: Dharwad- 580 002
State: Karnataka
59. Dr. H K Swathi

C/o: Kumarachar H B,
R/o. # Sri Gajanana Nilaya,
Sahyadri Circle,
Behind Kwality Coffee Works,
Northern Extension,
VTC: Hassan, PO: Hassan,
Sub District: Alur, District: Hassan- 573201
State: Karnataka
11
60. Dr Tejas Gundewar
S/o Vivek Gundewar,
R/o. Sushrut Hospital, Gtade Plot,
June Karad Naka, Pandharpur,
Solapur, Pandharpur-413304
Maharasthra
61. Veeramachaneni Padmaja

W/o gogineni Gangadhar,
R/o. 32-3-9, Anjamma Road,
Ratnamamba Riadm Moghalajpuram,
Vijayawada(Urban), Krishna,
Andhra Pradesh- 520 010
62. Dr. Sireesha

W/o Bapujee Naidu Mariseria
R/O. 9-29-21/1 Lakshmi residenci
Flat-No-C4 Balaji Nagar Siripuram
Near Tycoon Hotel Visakhapatnam (Urban)
A U Engg College Visakhapatnam
63. Dr. Madhuri

W/o: Dr Abijith R Honagodu
#41 3rd Cross
Anikethana Road South
Kuvempunagar Mysore
Kuvempunagar, Mysore, Mysore- 570 023
Karnataka
64. Anu Agarwal

W/o: Ashutosh Agarwal,
R/o. B 37/54 A-7, Ayushman Hospital,
Giri Nagar, Birdopur, Chhitupur,
Varanasi -221010 [Uttar Pradesh]
65. Dr. Vandana

C/o Sandeep Anehosur
R/o. 301 Scion Luxor Apartment
2nd K Cross Road H R B R Layout
1st Block Bangalore North, Bengaluru -560 043
Karnataka
12
66. Shruti Keerti B
W/o Subramanya
R/o. K R #31 Paridhi 2nd Main
Deshabandhunagara D B Sandra
Bangalore North, Bangalore- 560 097
Karnataka
67. Dr. Lakshmi Paavna

W/o K Satish
R/o. #239 32nd Ward
Hospet Road SR Hospital Bellary
Bellary Cantonment Bellary
Karnataka-583104
68. Dr Ashwini Gowdra

C/o: Aravinda G M
R/o.Flat No 1152 The Magic Faraway Tree
Kanakapura Main Road
Thalaghattapura
Bengaluru – 560062
Karnataka
69. Dr. G. Roshini

D/o Gundapanneni Ravindranath
R/o. H NO 25-13-19 R V Rama Rao street
Narasimharao Peta Near bustand Eluru
West Godavari- 534 006
Andhra Pradesh
70. Anindita Kundu

D/o. Swapan Kumar Kundu
68/27 Rrahuta Rroad
Banerjee Para, Basudebpur (P)
Shyamnagar, Barrackpur - 1 North 24 Parganas
West Bengal 743127
71. Kokila Sreenivas

C/o L D Sreenivasa
R/o. #20 Sukrutha Hospital
2nd Main 2nd Block, Majunatha Nagara
Tumkur Kuvempunagara Tumakuru -572 103
Karnataka
13
72. Dr. Indu S T Gopal
W/o Madhusudhana HR
R/o. #609 8th A Main, 4th Cross
Utharahlli Main Road, Bharath Housing
Co Operative Society,
Subramanyapura Bangalore South
Subramanyapura, Bangalore- 560061
Karnataka
73. Nabeela Lubna

D/o Akber Baig
R/o. No 268, 2nd Main J H B C S Layout Park
Kumaraswamy Layout 2nd Stage
Bangalore South Bangalore- 560 078
Karnataka
74. Durai
C/o Narayanan 380,
R/o.1st Floor 15th Street
TNHB Korattur, Ambattur Tiruvallur- 600 080
Tamil Nadu
75. Dr. Vidyalakshmi

D/o Arjunan,
R/o. No 104 Haiyatha Nagar,
5th Street, Pachal Tirupattur,
Vellore- 635 601
Tamil Nadu
76. Dr Vasundara
W/o Dr Kunal Kumar,
R/o. 18/29, Thiruvinnagar,
12th Avenue, Ashok Nagar, Chennai– 600083
Tamil nadu
77. Dr. Srividhya N.B

D/o Boranna gowda
R/o. N Y # Kalabhairaveshwara
Nilaya Kittur Rani Chennamma Road
2nd Cross, Vivekanagar Hassan
Vidyanagar (Hassan), Karnataka 573 202
14
78. Dr. Chaithra SK
D/o. S R Krishnaiah Manjunatha
Nilaya 1st Main Road, Nrupatunga Extn
Tumkur -572 102
Karnataka
79. Chinmanyie
D/o: Ramakrishna,
R/o. #16/990, 8th Main Road,
Girinagar 2nd Phase,
Near Girinagar Police Station,
Banashankari 3rd Stage, Bangalore South,
Banashankari III Stage, Bangalore– 560085
Karnataka
80. Dr Priyanka Rani

W/o: Nishith Sahu
R/o. Flat No T-9 Mana Pristine Apartment
Sarjapur Road, Dodda Kannelli,
Kaikondahalli Carmelaram,
Bangalore South Bangalore
Karnataka 560035
81. Dr. Shefali Bansal

W/o Manish Madhav,
R/o. Flat No. E-1, Block-3,
Green Valley Apartment,
Behind Vishal Cinema, Siliguri (M.Corp),
Darjeeling, West Bengal 734 001
82. Dr Ruchika Sofat

W/o: Amit Sofat
House NO- 443/1,Sangat Road
Near Kitty Bakery Civil Lines,Ludhiana
Ludhiana Bharat Nagar Chowk Ludhiana
Punjab 141001
83. Dr. Neelam Bapna

W/o: Ajay Bapna,
R/o. 92/206 Agarwal farm,
Mansarovar, Jaipur, Jaipur,
Rajasthan – 302020
15
84. Narendra Gupta
S/o Shambhu Dayal Gupta,
R/o. 62, Dhuleshwar Garden,
C-Scheme, Jaipur, GPO,
Rajasthan 302 001
85. Dr. Sowmya

C/o Dr. Rajashekar H B,
R/o. # 201 Brigade Splendour,
Lalithamahal Road, Nazarbad Mohaila,
Mysore, Mysuru, Karnataka 570 011
86. Dr. Sowmya

W/o Venugopal
R/o. #7/225 Vishweshwaraiah Road
7th cross Near Old Canara Bank
Vidyanagar Hassan Alur Hasan
Karnataka 573 201
87. Dr. Shweta Agarwal

C/o Ramesh Manglik
R/o. Nilgiri Mul Road, Opposite CHL Hospital
Sarkar Nagar, Chandrapur
Maharashtra 442 401
88. Dr.P.Shanthipriya
D/o Paramanandam,
R/o. 16 Kamalayam Malekarai,
Thiruvarur, Thiruvarur Taluk,
Thiruvarur, Tamil Nadu 610 001
89. Dr Sivakumar C
S/o Chandrasekaran,
R/o. 12, Pillaiyar Kovil Street,
Periyapuliyampatti, Aruppukkottai,
Virudhunagar, Tamil Nadu 626 101
90. Dr.C.Vijayalakshmi
W/o Kiran Kumar
R/o. Flat No-205 Sudarshan Towers
Mini Bypass Road Vanam Thopu
Center Nellore, Nellore Andhrakesan Nagar
16
91. Suryaprabha Karri
W/o Karri Srinivasula Reddy,
R/o. H No. 30-6-19, Kummarla Vari Street,
Opp Rotary Club, Tanuku Town,
Tanuku, West Godavari,
92. Dr. Jayshree Pathak

W/o Nikhil Sharma
R/o. C-1 Rampuri Chander Nagar
Ghaziabad,
Uttra Pradesh 201 011
93. Dr Sunita Chandra

W/o Sourabh Chandra,
R/o. 250/4-6, Second Street,
Rajendra Nagar, Lucknow,
UP – 226004
94. Govindaswamy D
S/o: Devarajan,
R/o. 110/8 Mel Street, Kothur,
Balur Kottur, Gudiyatham,
Vellore, Tamil Nadu – 635808
95. Hina Ali

C/o: Soheb Rafique
R/o. Tower 11, 2nd Floor
A1 Metro City Apartment
Nishatganj Paper Mill Colony
Mahanagar, Lucknow Uttar Pradesh – 226006
96. Dr. K.K. Gopinathan

S/O: KK Karunakaran,
R/o. Kings, Edapal, Opp.Block Office Edapal,
Edapal, Edappal, Malappuram,
Kerala- 679576
97. Dr. Swapneel Nilkanth Patil

S/o. Nilkanth Patil
R/o. 6-B Kamalayam,V Block,
Nagapillayar Kovil,Kovaipudur,
17
Coimbatore South-641042
Tamilnadu
98. Dr.Nishat Hashmi
D/o Ajaz Ahmed Hashmi,
R/o. 71h-6, Dr Sudhir Bose Road,
Near Lazmi Mandir, Khidderpore,
Kolkata, West Bengal – 700023
99. Shalini Nagpal

C/o Mohit Nagpal,
R/o. 1-G-21, Jawahar Nagar,
Ganganagar- 335 001
Rajasthan
100. Dr. Debalina Brahma

R/o. South Block Flat No 5A
Club Town Enclave, 20 Chinar Park,
Hatiyara, Hatiara, North 24 Parganas,
West Bengal – 700157
101. Dr. Parag Nandi

S/o Pijush Kanti Nandy,
R/o. 4/48, Bijoygarh Colony,
Jadavpur University, Kolkata,
West Bengal – 700032
102. Dr. R Aruna

W/o: Ashok Kumar,
R/o. 123, 2ND Cross Street,
Sri Lakshmi Nagar, Valasaravakkam,
Tiruvallur, Alwarthirunagar,
Tamil Nadu, 600087
103. Dr. Sumana Gurunath

W/o: Bidare Nagaraja Rao Upendra,
R/o. No 51, New BEL Road,
Near M S Ramaiah Park, 1 TI Layout,
Bangalore North, Msrit, Bengaluru,
Bangalore North, Karnataka, 560054
104. Dr. Pratibha Aggarwal

W/o. Vridhi Chandra Aggrawal
18
R/o. 2/181, Ground Floor,
Safdarjung Enclave, South West,
Delhi – 110029
105. Dr. Deeksha Tyagi

D/o Onkar Singh Tyagi,
R/o. C-183 Sarvodaya Enclave,
Malviya Nagar S.O. South Delhi,
Delhi 110 017
106. Dr. Vijaydeep Kaur

W/o Brijinder Singh,
R/o. House No 688-F,
Shaheed Bhagat Singh Nagar,
Rana Hospital, Pakhowal Road,
Vasant Avenue, Ludhiana-141013
Punjab
107. Jatin Shah

S/o: Pankaj Shah,
R/o. Flat No. 2601/ 2602,
C-Wing, Raheja Atlantis,
Ganpatrao Kadam Marg,
Next To Shree Ram Mill Compound,
Lower Parel, Delisle Road, Delisle Road,
Mumbai-400013
Maharashtra
108. Charushila Borole

R/o. Etenelle SOC 1303,
Behind Ganraj Mangal Karyalay,
Baner, Pune City,
Pune,– 411045
Mahrashtra
109. Meghashree Deshmukh
W/o Girish Deshmukh
R/o. H.No. 3-3-3, Kahalekar Niwas
Chikhalwadi Corner,
Vazirabad Bear, Halla Bol Chowk
Vazirabad Nanded-431 601
Maharashtra
19
110. Shikha Gupta
W/o Sandeep Gupta,
R/o. 57-58, Olive Homes, Sukhiya,
Near Kesar nagar Circle,
Sanganer, Jaipur- 302 029
Rajasthan
111. Dr.Priti Gupta

W/o: Athaluri Vishnu Vardhan,
R/o. 227-24/1, Gokul Street,
Srinagar, Kakinada (Urban),
East Godavari – 533003
Andhra Pradesh
112. Dr Mugdha Parasnis

302 Bhosale serenade apts
38 Bhosale nagar
Pune -411007
Maharashtra
113. Yejarala Kishore Babu

C/o Veeraiah,
R/o. Flat No.509 Pavan Classic Apartments,
Rama Nagar, 1st Line, Nidamanuru,
Enikerpadu, Krishna
114. V Meena
W/o V G Srinivasan
R/o. 17-504 Tilak Nagar
Upstairs S V Poly Clinic Nursing Home
Guntakal Anantapur
115. Dr. Basavaraj Devarashetty

R/o. A4 507 Yamuna Block
National Games Village Koramangala
Bangalore South
Bengaluru -560047
Karnataka
116. TY Mudaradi
S/o Yashvant
20
R/o. Guru Krupa Siddharooda
MATH Main Road, Old Hubli Hubli
Dharwad- 580 024
Karnataka
117. Biplab Roy Chowdhury

R/o. 124B Rasbhehari Avenue
Kolkata -700029, West Bengal
118. Dr. Parasuram Gopinath

R/o. CIMAR Cochin Hospital,
Bus Stop, 3/515-A, Tippu
Sulthan Road, Thykkavu Jn,
Cheranellore P.O, Cochin -682034
Kerala
119. Dr. Riza Rehman

C/o AbdulJaleel KA,
R/o.10 A Cotton Hill Heights,
Vazhuthacaud, Thiruvananthapuram,
Kerala – 695010
120. Dr. Usha P

W/o: Dr Sathish A,
R/o. Panchajanyam, Edappal,
Edappal, Malappuram,
Kerala – 679576
121. Nishant Dixit

S/o: Pradeep Kumar Sharma,
R/o. Kalapataru, D-5, Plot No : - 06,
Shrirampura, Civil Lines,
Jaipur – 302006
Rajasthan
122. Dr. V.N. Shivabagutti

C/o. Ningappa
R/o. Suviksha, Plot No. 93 & 94,
Chandragiri Layout
Near Rajeevnagar Police quarter,
Vidyanagar,VTC, Hubli-580030
Karnataka
21
123. Gurunath Pattar
S/o. Ishwarappa
R/o. Plot No. 47 Near S C Motors,
Belgaum, Shivan Nagar Hukker
Belgaum- 590 016
Karnataka
124. Dr. Hitha Kashi

D/o Dr. Kashinath K R,
R/o. Gurusparsha, 3rd Main Road,
Gandhi Nagar,
Tumkur- 572102
Karnataka
125. Dr Ruchi Hooda

C/o. Rameshwar Lal Bishnoi
R/o. B-247,B-Block,Derawal Nagar,
Dr. Muhkerjee Nagar,
North West Delhi-110009
126. Dr.Karthika D Kumar

Bus Stop, 3/515-A, Tippu
Sulthan Road, Thykkavu Jn,
Cheranellore P.O, Cochin-682034
Kerala
127. Dr. Syed Monajatur Rahman

S/o. Syed Abdul Khaleque
MASAT, Sangrampur, Masat,
South 24 Parganas- 743375
West Bengal
128. P J Suresh
S/o P J Lakshmanna ,
R/o. 2 -6 8, Lakshmipuram, Laxmipuram,
Kurnool- 518 2 18
Andhra Pradesh
129. John Louis

S/o: Arokiadass,
R/o. 328, 1st Stage, Kuvempu Ngar,
Jalahalli East, Bangalore North,
22
Bangalore, Jalahalli East,
130. Divya Vengugopalan

D/o: P Venu Gopalan,
R/o. 499, 7th Cross, 2nd Block, H
BR Layout, Banglore North,
Bangalore, Karnataka – 56
131. Dr. Neerja

W/o: Doctor Vijay Kumar,
R/o. E-2, Basant Vihar,
Neerja Hopsital, Sikar – 332001
Rajasthan
132. Dr Honey Qureshi

D/o Mohammad Saeed
R/o. M.N.344 Shree pura
Lucky School ke pass, Kota City S.O
Kota-324006
Rajasthan
133. Dr Ashok Kumar

S/O: Arumugam,
R/o. 123, 2ND Cross Street,
Sri Lakshmi Nagar,
Valasaravakkam, Tiruvallur, Alwarthirunagar,
Tamil Nadu, 600087
134. Anjana Rathi

W/o Dr. Rajendra Rathi,
R/o. 2b/25, Saket Nagar, Hosing board,
Rathi Hospital, Beawar, Ajmer-305901
Rajashtam,
135. Dr A.A.L. Satyavati
W/o: Athaluri Vishnu Vardhan,
R/o. 227-24/1, Gokul Street,
Srinagar, Kakinada (Urban),
East Godavari, Andhra Pradesh – 533003
136. K Aruna Kumari

W/o Satya Sai Prasad
23
R/o. 75-1-7 Prakash Nagar
Second Street Rajahmundry
East Godavari, Andhra Pradesh 533 101
137. Dr. Meeta Airen

W/o Shailendra Kumar Airen,
R/o. K-6, Andrewganj Extension,
Andrewganj, South Delhi,
Delhi -110049
138. Sarita Jain

W/o: Ajay Jain,
R/o. Ward No:6, Nayako Ka Mohalla,
Sikar – 332001
Rajasthan
139. Dr. Kalyani Ingale

W/o Kundan Ingale
R/o. C-804, Five Gardens Society
Rahatani Pune City, Pimpri Colony
Pune -411 017
Maharashtra
140. Dr Seema
W/o. Ashwin
R/o. R S No. 136, Masurkar Hospital Naka No.1
Yaragatti Road, Gokak, Begaum,
Karnataka-591307
141. Naresh Kumar Donkena

C/o Donkena Bala Raju Goud,
R/o. Flat No-5G, 5th Floor B
lock-1 Ecopolis Mahanagar Homes,
Lalitha Nagar, Anand Nagar X Road,
Bandlaguda, Hayathnagar, K.V.Rangareddy,
Telengana 500 068
142. Pradeep Kumar

S/o Dinesh Prasad Gupta,
R/o. Baniya Tola, Sonbarsa,
Bhojpur, Bihar, 802112
24
143. Dr. Lipi
Killikattu Prasanth
Kalavoor PO
Kalavoor, Alappuzha
Kerala - 688522
144. Dr. Sapna Basandani

W/o Shankar Basandani,
R/o. House No 380, Near Jain Mandir,
Adarsh Nagar, Jaipur-302004
Rajasthan
145. Dr. Jeyachitra.G

D/o. Jeyapragasam
R/o. Nithilaa Nursing Home
61,TPK Road
Palanganatham, Madurai
Tamilnadu
146. Dr. Revathi K

W/o Rajeesh,
R/o.11 Chidambara Nathan Street,
Ramavarmapuram Nagercoil,
Agasteeswaram, Kanniyakumari,
Nagercoil-629001, Tamil Nadu
147. Dr.Deepthi
D/o. Surendran C
R/o. 29/563 Sreehari Kannam
Pariyaram West Yakkara
Palakkad – 678001
Kerala
148. Dr. Betty John Ferns
Bus Stop, 3/515-A, Tippu Sulthan Road,
Thykkavu Jn, Cheranellore PO. Cochin
Kerala
149. Ankit Shukla

S/o: Arvindra Kumar Shukla,
R/o. Bhatkhera Ward, Haidergarh,
Haidergarh, Bara Banki,
25
Uttar Pradesh – 227301
150. Dr N Kathya
W/o: Yedla Harish Kumar
R/o. 8/399 S S Road, Proddatur Proddatur,
Cuddapah Andhra Pradesh – 516360
151. Hemanth Kumar

S/o: Anjaneya MV,
R/o. # 786/786 Eeramma Nilaya,
2nd Main 4th Cross, Ashoka Nagar,
Shimoga, Shivamogga, Karnataka – 577201
152. Dr Anu R
D/o: K N Remanan,
R/o.Mullackal, Manganam,
Kottayam, Kerala – 6866018
153. Dr . Bharti Bansal

W/o: Ujjwal Bansal,
R/o. Bansal Hospital,Shiv Chok,
National Highway -62, Ganganagar,
Rajasthan Roadways Dipo Samne,
Ganganagar – 335001
Rajasthan
154. Dr Simi Mohandas

W/o. Arun P.B.
Kezhukoot House, Muriyad, PO. Muriyad, Muriyad,
Thrissur, Kerala, 680683
155. Rajyalakshmi Adusumilli

W/o Narukurthi Madhu
R/o. Sai Sankaram 7-2-1757 401
Vasavi Meadows Bunglow,
49 Main Road Czech Colony Street No 1
Sanathnagar Hyderabad Rangareddi
156. Dr. Suchika Mangal

W/o Geetesh Mangal,
26
R/o. B-202/A, Rajendra Marg,
Bapu Nagar, LAL Koth Jaipur,
Gandhi Nagar- 302 015
Rajasthan
157. Anita Choudary

W/o: Vijay Prakash,
R/o. Khichar, Khichar Hospital,
Hawalgarh Road, Ward 42,
Sikar, Nathawatpura,
Rajasthan, 332001
158. Dr. Kundan Ingale

R/o. C-504, Five Gardens Society,
Rahatani, Pune City, Pune,
Maharashtra – 411017
159. Dr. Ragini

D/o.Hariba
R/o. Neharu Colony Behind Police Quarters
Gulbarga Gb Ggh
Gulbarga Karnataka – 585105
160. Dr Shweta Goswami

W/o: Vikas Goswam,
R/o. D 158, 1st Flor. Near Indra Market,
Sector-25, Noida, Gautam Buddha Nagar,
Uttar Pradesh, 201301
161. Dr Phani Madhuri

W/o: Sunil Kini G
R/o. # 2336, 17th Cross
R/o. Opp Gayathri Temple
HSR Layout, Sector-1 Bangalore
South Hsr Layout
Bangalore South Bengaluru
Karnataka 560102
162. Dr Samidha Dalvi

W/o Vikram Amale
R/o. 9B-1103, Kalpataru Estate
Phase-3, Jawalkar Nagar
27
Pimpale Gurav Pune Pimple
Gurav Maharashtra – 411061
163. Dr Ruchi Bhandari

W/O: Chirag Bhandari,
R/o. 391, Vasundhara Colony,
Tonk Road, Jaipur, Durgapura,
Jaipur, Rajashtan – 302018
164. Dr Sree Hari

S/O Arunkumar,
R/o. #217 Laughing Waters,
3rd Main, Ramagondanahalli,
Bangalore North, Whitefield,
165. Dr Sadhu Suneetha

W/o. Vamsi Krishna
R/o. 1-37/1,Srinivasa Puram,
Tiruchanoor Road tirupati,
Padmavathi puram,Vagilallvaram,
Trruchanoor-517503,AP
166. Alka Gahlot

W/o: Bharat Singh Gahlot,
R/o. H E- 579, Vishwarmitra Marg,
Near Sanskar School,
Hanuman Nagar Extension Sirsi road,
Jaipur, Rajasthan – 302012
167. Dr Aradhana Kalra

D/O Amrit Sagar Kalra,
R/o. House No 2347, Sector 16,
Faridbad, Haryana- 121002
168. Dr. Hebbatam Hyma

W/O Gondi Naga Mohan Rao,
R/o. 12-2-953, Sai Nagar,
Second Cross, Sai Nagar,
Anantpur, Andhra Pradesh – 515001
28
169. Dr. Vibha Kailash Garg
W/O Dr. Kailash Chandra Garg
R/o. Kesar Kothi, A-22 Lal Bahadur Nagar
J.L.N. Marg, Jaipur, Rajasthan 302 017
170. Dr. Gayathiri Ganesan Ram

C/O Ganesan Ram,
R/o. 78, Alagarkovil Road, Melur,
Madurai, Tamil Nadu 625 106
171. Dr. Vinayaka

C/O Narayanappa Sneha bandu,
R/o. Mother Teresa Road,
Near Old canara bank Circle,
Vidyanagara, Hassan
Karnataka 573 202
172. Dr.K.S. Rupa

W/o. Dr Umesh C,
R/o. Flat S-2, 2 Floor, 819/1/3,
Arjun Sagar Residency,
13th Cross Road, 7th Block
Jayanagar, Bangalore,
Karnataka 560 070
173. Dr.Maheshwari
D/o. B S Mohan Kumar
R/o. #491 5th Cross Veenesheshanna
Road K R Mohaila ,Mysore
Karnataka-570 024
174. H. Bembem
W/o Palash Biswas
R/o. #150 8th Cross 29th Main
BTM layout 2nd Stage Bangalore South
Bangalore Karnataka 560 076
175. Sravan Kumar

S/O Jayaramaiah
R/o. #Q302 Renaissance Exotica
Jakkur Planatation, Jakkur,
Aerodrome, Yelahanka,
29
176. Vandana Annappa Reddy

W/o Jayaprakash M S,
R/o. #44/3, 2nd Main Road,
Near Garadi Apartments, Tata silk,
Farm, Basavanagudi,
Bangalore, Karnataka 560 004
177. Kaveri Gupta

W/o Dr. Shalabh Gupta,
R/o. B-38/1-C, Birdopur,
Mahamooraganj, Varanasi,
Chhitupur, Varanasi,
Uttra Pradesh 221 010
178. Roopa Vernekar

W/o Suraj D Vernekar
R/o. # 110 1st Main M S Raman City
J P Nagar 8th Phase Bangalore South
Bannerghatla Road,
Bengaluru Karnataka 560 075
179. Dr. Rupa Rajshekar

W/o Shailendra V L,
R/o. # 1157, Spurthi, Behind L I C Building,
25 Main J P Nagar 1 st Phase,
Bengaluru, Karnataka 560 078
180. Dr. Meena J

D/o Yashodha, 3 1332,
R/o. Muninagappa Layout 3rd Cross,
Kaval Byrassandra, Bangalore North,
R T Nagar, Bangalore, Karnataka 560 032
181. Dr. Rashmi Yogish

C/o Yogish Vijayakumar,
R/o. HNo 36, 36th Mn Dollars Schemme Lyf,
Near Silk Board And St Miras High School,
BTM 1st Stage, VTC Madivala,
PO. Bommanatalk Sub
District: Anekal,
30
District: Bengaluru,
State Karnataka 560 068
182. Dr. Ramesh Gaikwad

R/o. Ghar N.57 Pabal-Shikrair Road
Near Post Office, Dhamari Shirur
Dhamari Pune Maharashtra 412 403
183. Prakash PK
S/o. Palanethra,
R/o. Isuvanahalli, Doddabele,
Bangalore Rural, Karnataka 562132
184. Raksha R
R/o.Raghunath
No 6 S1 Sneha Apartment 2nd floor,
3rd Cross Road SVG Nagar,
VTC Moodalapalaya. PO: Nagarbhavi,
District: Bengaluru.
Karnataka PIN Code 560072
185. Pritam Prakash

R/o. E 1902 Empire Square,
Old Mimbao Pine Highway,
In front of Ranka Jewlers, Pune City,
Pune, Maharashtra – 411019
186. Dr. Sharmistha

R/o. Newlife fertility Center
Homeland Business Centre
Near Vega Circle Mall Sevok Road,
3 rd mile, Siliguri West Bengal 734008
187. Ajitabh Shukla

R/o. MM super speciality Hospital,
Mullana(Ambala)-133207
Punjab
188. Dr. K Aarthy

W/o. Paari Raja
R/o. Paari Nagar, Sugam by pass
31
Coimbatore-641045
Tamilnadu
189 Dr Ramya
W/O: Vinay Shukla,
R/o. House Number - 128/1169,
Y-Block, Kidwai Nagar, Kidwai Nagar,
Kidwai Nagar, Kanpur Nagar, Kanpur,
Uttar Pradesh- 208011
190. Dr Manjiri Valsangkar

R/o. 22, Anandbaug, Near Vaikunth Navi,
Peth, Pune City, SP College,
Pune, Mahrashtra, 411030
191. Ramkumar Kollana

R/o. 1-8-31/1, Minister Road,
Krishna Nagar Colony, Begumpet,
Secunderabad,, Hyderabad,
Telangana 500003
192. Amrita das

R/o. 3 , BRS Lane. Kolkata: 12
West Bengal.
193. Dr. Anuj Sharma

R/o. L-5 Shastri Nagar Medical
PO.: L. L. R. M. Med College, Meerut
Uttar Pradesh 250 004
194. Dr. Surheeta Kareem

W/o: Vijahat Kareem,
R/o. 1/126ba, Daudpur, Gorakhpur,
Uttar Pradesh – 273001
195. Dr Sushma Pampanavar

R/o. No 35C 6th Main 1st stage ,
KHB Colony, Basaveshwar Nagar
32
Bangalore 560079
Karnataka
196. Dr. Afsha Firdouse

R/o. IVF Center, Rainbow Hospitals,
Hyderabad
197. Sudhakar
S/o Cholan,
R/o. L37/4 TNHB Colony,
Central Avenue, Korattur,
Korattur Tiruvallur,
Tamil Nadu 600 080
198. Dr Sangita Sharma

R/o. A 803, Melodia, Gandhi Path,
Vaishali Nagar, Jaipur
Rajasthan
199. Vanitha Metgud

R/o. BC-82, Kasmet, Old St.Marry Church
Tang Road Camp Belgaum
Belgaum Hukeri Belgaum
Karnataka 590 001
200. Dr. Varsha Agarwal

R/o. Flat no 805 A block
Gaur Grandeur Sector 119 NOIDA
Gautam Budh Nagar, UP
201. Dr Srinivas MS
S/O: Shivalingaiah
R/o. # 555 Sadhne 26th Main
Nandini Layout Bangalore North
Nandinilayout Bengaluru
202. Dr. Santosh Gupta

33
R/o. C 112 , Sobha Magnolia Apartments
Opposite Jal Bhawan
Bannerghatta Road , Bangalore
Karnataka
203. Dr. Bhavya

R/o. G1101, The Plam Drive,
Golf Course Road Ext, Sector 66,
Badshahpur, Gurgaon -122101
Haryana
204. Karan
R/o. Jayanagar, 26,
Pattalamma Temple Rd,
Basavanagudi, Bengaluru,
Karnataka 560004
205. Radha Reddy

R/o. IVF Center, Rainbow Hospitals,
Hyderabad
206. Saurav Dutta

R/o. Newlife Fertility Centre,
Homeland Business Centre,
Near Vega Circle Mall,
Sevok road, 3 rd Mile Siliguri,
West Bengal 734008
207 Dr Anju Mathur
W/O: Amit Mathur,
R/o. 5/14, Jawahar Nagar,
Tooty Pulia, Jaipur, Jawarhar Nagar,
Jaipur, Rajashtan – 302004
208. Kirana T
W/o Harinath
R/o. B Flat No 303
Feel Well Towers Khaleelwadi
Khaleelwadi Near Bus Stand
Nizamabad Gajulpet
34
Nizamabad Telangana 503 001
209 Kavya Sharma D

W/O Arun Kumar N
R/o. # 196 3rd Cross
Near Ganesha Temple Gandhipuram,
Whitefield Bangalore North Bangalore
Bengaluru Karnataka 560 066
210. Dr. Surabhi Tomar

W/o: Eshan Sharma,
R/o. 4 Govind Marg,
Near Moti Dungri, Jawarhar Nagar,
Jaipur, Rajasthan, 302004
211. Dr Bhavya Jha

R/o. Triveni IVF and Fertility Centre,
Bengaltitola,VIP Road,
Darbhanga, Bihar- 846003
212. Dr Priya Dahiya

R/o. Flat no 288, Ekta Apartments
Sector 3 , Pocket 1&2
Dwarka, New Delhi 110078
213. Dr Lavleen Kaur Sodhi

W/O: Dr Sathish A,
R/o. Panchajanyam, Edappal,
Malappuram, Kerala – 679576
214. Neha Gupta

C/o Sumant Gupta,
R/o. 201, Ground floor,
Sukhdev Vihar, South Delhi,
New Friends Colony, Delhi 110025
215. Dr.K.Monika Reddy

D/o K Monika Reddy,
R/o. 9-8-18, Flat No -302,
35
Sai Ram Sesy, Maruthi Nagar,
Champapet, Aaidabad, Hyderabad,
216 Nirmala Mohan

W/o M C Mohan,
R/o. # 122, 3rd Main Road,
A G S Colony Anand Nagar,
Bangalore North, Bangalore,
Karnataka 560 024
217. Rangoli Mathur

W/O. Saurabh Mathur,
R/o. Sec-9, 94/7, Khumba Marg
Pratap Nagar, Sector 11, Jaipur,
Rajasthan 302033
…… Petitioners
//Versus//
1. Union of India
Ministry Health and Family Welfare Department
Thr. Its Secretary Nirman Bhawan,
District: New Delhi
2. Ministry of Women and Child Development (GoI)
Thr. It„s Secretary
Room No. 305, B Wing, VIth Floor,
Shastri Bhawan, New Delhi

36
3. Indian Council of Medical Research
Thr. It„s Secretary
V. Ramalingaswami Bhawan, P.O. Box No. 4911,
Ansari Nagar,
New Delhi – 110029 .... Respondents
[ALL ARE CONTESTING RESPONDENTS]
To
The Hon'ble Chief Justice of India
And his other companion Judges
Of the Hon'ble Supreme Court of India
The humble Petition of the

Petitioner above named.
MOST RESPECFULLY SHOWETH
1. That the petitioners are citizens of India and are
competent to invoke extra-ordinary jurisdiction of the
Hon‟ble Court under article 32 of Constitution of India.
2. That on 10.12.1948, the General Assembly of the United
Nations adopted the Universal Declaration of Human
Rights(UDHR). That Article 12 of the Universal Declaration
of Human Rights, to which India is a signatory, states that

37
no one shall be subject to arbitrary interference with
his/her privacy family, home or correspondence nor to
attacks upon his/her honor and reputation.
Nations adopted the International Covenant on Civil and
Political Rights(ICCPR). The relevant articles of the ICCPR
are reproduced herein below:
“Article1.1:All peoples have the right of self-
determination. By virtue of that right they freely
determine their political status and freely pursue their
economic, social and cultural development.
Article17.1:Noone shall be subjected to arbitrary or
unlawful interference with his privacy, family, home or
correspondence, nor to unlawful attacks on his honour
and reputation.
Article 23.1: The family is the natural and
fundamental group unit of society and is entitled to
protection by society and the State:”
That India ratified the ICCPR on 10.04.1979.

38
4. That on 03.10.1978, Ms. Kanupriya Agarwal @Durga was
born in Kolkata, India and is widely regarded as the
world‟s second test tube baby.
Nations adopted the Convention on the Elimination of all
Forms of Discrimination Against Women (CEDAW). The
relevant articles of the CEDAW are reproduced as herein
under.
Article 12:
States Parties shall take all appropriate measures to
eliminate discrimination against women in the field of
health care in order to ensure, on a basis of equality of men
and women, access to health care services, including those
related to family planning.
Notwithstanding the provisions of paragraph 1 of this
article, States Parties shall ensure to women appropriate
services in connexion with pregnancy, confinement and the
post-natal period, granting free services where necessary,
as well as adequate nutrition during pregnancy and
lactation.
39
Article 16 (1)(d): The same rights and
responsibilities as parents, irrespective of their marital
status, in matters relating to their children; in all cases the
interests of the children shall be paramount;
A true copy of the Convention on the Elimination of
all Forms of Discrimination Against Women adopted by the
United Nations General Assembly on 18.12.1979 is annexed
herewith and marked as ANNEXURE-P1 at page No. 106 to
115.
6. That on 06.08.1986, India‟s first scientifically documented
IVF baby, Harsha, was born in Mumbai, through the
collaborative efforts of the Institute for Research in
Reproduction of the Indian Council for Medical Research
(ICMR) and the King Edward Memorial Hospital (KEM),
Mumbai.
7. That on 09.07.1993, India ratified the Convention on the
Elimination of all Forms of Discrimination Against Women
(CEDAW).
40
8. The Committee on Economic, Social and Cultural Rights
in their comment on Article 12 of ICESCR has observed
that the right to sexual and reproductive health is an
integral part of the right to the highest attainable physical
and mental health.
9. That the Article 51 of the Constitution requires the state to
foster respect for international law and treaty obligations
in the dealings of organised people with one another. The
Protection of Human Rights Act 1993 recognises and
incorporates international conventions and treaties as
part of Indian human rights law. International human
rights norms contained in treaties and covenants ratified
by India are binding on the state to the extent that they
elucidate and effectuate the fundamental rights
guaranteed by the Constitution.
10. That the Directive Principles of State Policy in Part IV of
the Constitution lay down the fundamental principles in
the governance of the country and press upon the state to
apply them while making laws. Article 38(2) of the

41
Constitution requires the state to promote the welfare of
people and eliminate inequalities in opportunities:
“Article 38. State to secure a social order for the
promotion of welfare of the people - ***
(2) The State shall, in particular, strive to minimize the
inequalities in income, and endeavour to eliminate
inequalities in status, facilities and opportunities, not only
amongst individuals but also amongst groups of people
residing in different areas or engaged in different
vocations.”
11. Further, Article 47 of the Constitution contains a call to the
state to improve public health:
“47. Duty of the State to raise the level of nutrition and the
standard of living and to improve public health – The State
shall regard the raising of the level of nutrition and the
standard of living of its people and the improvement of
public health as among its primary duties and, in
particular, the State shall endeavour to bring about the
prohibition of the consumption except for medicinal
purposes of intoxicating drinks and of drugs which are
injurious to health.”
42
12. India is the first and only country to explicitly adopt
scientific temper in its constitution. In the forty-second
amendment in 1976, Article 51 A(h) was added under
the Fundamental Duties that states that It shall be the duty
of every citizen of India to develop scientific temper,
humanism and the spirit of inquiry and reform.
13. Infertility affects more than 80 million people worldwide.
Infertility affects women‟s identity, status and security and
they experience stigmatisation, isolation and
powerlessness. Childless women are more vulnerable to
blame, mental and physical violence, threats of
abandonment, divorce and social exclusion. They are
under psychological, familial and community pressure to
have their own biological child. They seek treatment,
including assisted reproductive technologies (ARTs), if
affordable. Adoption is not popular though some couples
grudgingly adopted before ARTs were introduced.
14. In some societies religion and law prevent couples from
using donated gametes but in many they are ethically and

43
legally accepted and in some the restrictions are ignored
in the desperation to have a child. Some couples travel
abroad to access donor gametes and ARTs that are not
accessible in their own, for legal or other reasons. It is
broadly understood that gamete and embryo donation are
safe, cost effective and beneficial for infertile couples. But
their use has given rise to contentious issues and an
understanding of the science, guidelines, ethical and legal
and social implications of these procedures is required for
them to be used safely and effectively. So far it has been
difficult to find an international consensus on how to deal
with these issues as there are social, cultural, religious
differences, but each society needs to develop and
implement its own statutes.
15. Egg donation issues: Egg and embryo donation has been
used to treat infertility for a variety of conditions. Use of
egg donors is regulated in many countries but the high
demand for donors has led to waiting lists and shortages.
The increased international demand for donor eggs has
triggered a surge of egg donation and even international
travel for fertility treatment and even mail order oocyte

44
donation, which raises ethical issues of possible
exploitation of underprivileged women. Egg donation is a
cumbersome procedure and for some, it goes against
socio-cultural norms. Payments to donors has been
considered as ethically acceptable but there are
arguments against payment that consider inequality, co
modification and exploitation of donors .
16. The interests of gamete donors have only recently been
recognized internationally in assisted reproduction.
Traditionally, the interests of the patients (typically a
couple) and the prospective child were paramount.
However, assisted reproduction would not be possible
without donors, and the simple utilitarian view would be to
place their interests first to maximize the availability of the
practice.
17. That as per a detailed survey conducted on ART processes
in around 43 European countries including the maximum
number of egg donations allowed, it was found that most
of these countries allowed oocyte donation from upto six
to 10 times for successful pregnancies. A copy of the

45
survey report is annexed herewith as ANNEXURE –P2 at
page No. 116 to 131.
18. That as per research conducted by the American Society
for Assisted Reproductive Technology, the concern about
human commodification is based on the presumption that
compensation to individuals for reproductive and other
tissues is inconsistent with maintaining important values
related to respect for human life and dignity. Arguably,
this view is reflected in laws prohibiting direct
compensation to individuals providing organs and tissues
for transplantation. Yet, such laws generally permit organ
and tissue donors to receive reimbursement for expenses
and other costs associated with the donation procedure.
These facts support the compensation of oocyte donors as
well. That in countries like UK, egg donors are allowed
compensation of upto £750 per donation „cycle‟ to cover
their costs (a donation cycle is one complete round of
treatment, at the end of which the eggs are collected and
donated), and any further expenses for travel,
accommodation and childcare. A copy of the research
paper published by American Society for Assisted

46
Reproductive Technology is annexed herewith and
marked as ANNEXURE-P3 at page No. 132 to. 156.
19. That currently, oocyte and sperm donors are reimbursed
for time and expenses in over than one-third of countries
(e.g. Argentina, Australia, Belgium and China), while 16
countries provide compensation beyond reimbursement
(e.g. Chile, Nigeria, Slovenia and Spain). Thus there is a
need to reassess current policy toward the
implementation of a compensation scheme for egg donors
which goes beyond mere medical insurance, to also
include compensation for discomfort and health risks and
physical intrusions, which tend to be experienced more
frequently by female donors.
20. In fact in a 2012 study in Belgium found that donating eggs
does not have any adverse effects on a female‟s body and
does not reduce the chances of getting pregnant. In that
study, of the 60 women who tried to conceive after
donating eggs, 57 were able to conceive without help. Of
the remaining three who required fertility treatment, two
sought treatment due to their partner‟s infertility.

47
21. Table below compares the ART Act with the laws in some
other countries which regulate ART procedures.
International comparison of ART laws
Australia
United
Country India South Africa Canada
Kingdom
(Victoria)
Reimburse
Medical
ments
expenses Reasonable Reasonab
Payment to Reasonable include for
and medical le
the donor expenses travel and
insurance expenses. expenses
counselling
coverage.
.
Male
between
Age of 21-55
Not At least 18 Not Not
commissio
specified years of age specified. specified.
ning party Female
between
21-50
Only one Donated
donation gametes
Not more
for an egg Not more cannot be
than six
Restrictions donor than 10 Not used to
births using
on donors (with up families per specified. produce
donor
to 7 eggs donor. more than
gametes.
retrieved) 10
. families.
48
22. In 2005, the ICMR and NAMS issued the National
Guidelines for Accreditation, Supervision and Regulation
of ART Clinics in India. Bereft of any other guidelines or
statute governing the field of surrogacy and or Assisted
Reproductive Technology (ART), the said guidelines
became the de facto rules in the said sphere. Needless to
say, not being de jure rules framed under an appropriate
statute, the said rules were in applicable in legal disputes
before the Courts. The said Guidelines specifically stated
that single women could use Artificial Reproductive
Techniques and that no ART clinic could refuse its services
to such women. A true copy of National Guidelines for
Accreditation, Supervision and Regulation of ART Clinics
in India, 2005 is annexed herewith and marked as
ANNEXURE-P4 at page No. 157 to. 289.
23. The petitioners were following the guidelines of 2005 in
toto and were working strictly in accordance with the
guidelines of ICMR.
24. That thereafter the Law Commission suo-motu took up the
subject of the need for legislation to regulate Assisted

49
Reproductive Technology Clinics as well as rights and
obligations of parties to surrogacy. The Commission
presented its 228th Report in 2009 which stated that the
growth in the ART methods was recognition of the fact that
the infertility as a medical condition is a huge impediment
in the overall well-being of couples. The Commission
recognized the fact that the legal issues related with
surrogacy were very complex and needed to be
addressed by a comprehensive legislation.
25. In contradiction to the guidelines of ICMR, 2010, the Govt.
of India promulgated the provisions of the ART
(Regulation) Act, 2021 and ART (Regulation) Rules, 2022.
These provisions have not only changed the entire
procedure and has made the process of IVF / ART nearly
impossible to implement but have also taken away the
right ofegg donors and has made the entire process so
cumbersome and onerous that doctors as well as
commissioning couple will shy away from ART services.
26. The Assisted Reproductive Technology (Regulation) Act,
2021(herein after referred to as the “ART Act”) came into

50
force on 25.01.2022. The statement of objects and reasons
of the ART Act states as follows:
assisted reproductive technology clinics and the assisted
reproductive technology banks, prevention of misuse,
safe and ethical practice of assisted reproductive
technology services for addressing the issues of
reproductive health where assisted reproductive
technology is required for becoming a parent or for
freezing gametes, embryos, embryonic tissues for further
use due to infertility, disease or social or medical
concerns and for regulation and supervision of research
and development and for matters connected there with
or incidental thereto.
27. The ART (Clinic) Rules were thereafter promulgated on
07.06.2022.
GROUNDS FOR CHALLENGE:
The present Writ Petition has been filed challenging the
provisions under Section 21(b) r/w Rule 3, Section21(g),

51
Section 22(1)(b), Section 27(4), Section 29 and Section 33
of the ART Act as being irrational, unscientific and
unconstitutional, andviolative of the rights of reproductive
autonomy and bodily privacy of women which are
fundamental to the Right to life guaranteed under Article
21 of the Constitution. The aforesaid provisions are
challenged on the following grounds:
ART ACT IS DISCRIMINATORY AND
UNCONSTITUTIONAL AND IN DEROGATION OF
ICMR GUIDELINES, 2010 AND INTERNATIONAL
BEST PRACTICES:
A. Because the statement of objects and reasons of the
ART Act is as follows:
assisted reproductive technology clinics and the
assisted reproductive technology banks, prevention
of misuse, safe and ethical practice of assisted
reproductive technology services for addressing the
issues of reproductive health where assisted
reproductive technology is required for becoming a
parent or for freezing gametes, embryos, embryonic

52
tissues for further use due to infertility, disease or
social or medical concerns and for regulation and
supervision of research and development and for
matters connected therewith or incidental thereto.”
That while the intent of the legislature behind
framing of the Assisted Reproductive Techniques
Act, 2021 is to prevent misuse and promote safe and
ethical practices for addressing issues of
reproductive health, it is pertinent to mention here
that in the drafting of the ART Bill, 2021, no members
of the scientific committee were invited for their
proposals and suggestions. Resultantly, the
provisions under challenge in the ART Act, 2021 are
without any scientific basis and unreasonable,
specially in a field which requires medical and
scientific knowledge and expertise for its proper
implementation.
B. Because the provisions under challenge make ART
processes extremely onerous, cumbersome as well
as expensive for childless couples/women and

53
hence is counterproductive and has virtually brought
third party donor cycles in the entire country to a
standstill, adding to the miseries and woes of
couples already reeling under the trauma of
infertility.
C. Because the restrictive regime brought about by the
ART Act, 2021has had the effect of confining it to a
miniscule upper class of the citizenry, which is
discriminatory and a regressive move in the realm of
reproductive rights, considering infertility affects
almost 27 million couples in India and around 20%
women in the reproductive age groups, making it
violative of Articles 14 and 21 of the Constitution.
D. Moreover the provisions under challenge have the
effect of infringing upon reproductive autonomy of
egg donors and donees by restricting the number of
egg donations to one and imposing age restrictions
for availing ART services even in case of third party
donations.
54
E. Because the provisions under challenge have been
incorporated without taking into account the ICMR
guidelines of 2010, which was formulated by experts
in the field, thus having a scientific backing and was
being followed by IVF practitioners throughout the
country provisions as model rules till the time the
ART Act and Rules came into force.
F. Because the ART Act, 2021 is also not in consonance
with international treaty obligations and international
best practices when it comes to oocyte donations.
UNREASONABLE RESTRICTIONS ON NUMBER OF
OOCYTE DONATIONS:
G. Because Section 27(4)of the ART Act arbitrarily
impose several restrictions on oocyte donors, which
apart from being unscientific and economically
unviable, are also ICMR guidelines of 2010 and
international best practices in IVF apart from being
an infringement upon the eggdonor‟s reproductive
autonomy which is guaranteed as part of Article 21 of

55
the Constitution. Section 27 of the ART Act is
reproduced hereinbelow:
“27. (1) The screening of gamete donors, the
collection, screening and storage of semen; and
provision of oocyte donor, shall be done only by a
bank registered as an independent entity under the
provisions of this Act.
(2) The banks shall—
(a) obtain semen from males between twenty-
one years of age and fifty-five years of age, both
inclusive;
(b) obtain oocytes from females between twenty-
three years of age and thirty-five years of age;
and
(c) examine the donors for such diseases, as may
be prescribed.
(3) A bank shall not supply the sperm or oocyte of a
single donor to more than one commissioning
couple.
(4) An oocyte donor shall donate oocytes only once
in her life and not more than seven oocyte shall

56
be retrieved from the oocyte donor.
(5) All unused oocytes shall be preserved by the
banks for use on the same recipient, or given for
research to an organisation registered under this
Act after seeking written consent from the
commissioning couple.
(6) A bank shall obtain all necessary information in
respect of a sperm or oocyte donor, including the
name, Aadhaar number as defined in clause (a)
of section 2 of the Aadhaar (Targeted Delivery of
Financial and other Subsidies, Benefits and
Services) Act, 2016, address and any other
details of such donor, in such manner as may be
prescribed, and shall undertake in writing from
such donor about the confidentiality of such
information.
Explanation.—For the purposes of this section,
the expressions— (i) "retrieval" means a
procedure of removing oocytes from the ovaries
of a woman; (ii) "screening" means the genetic
test performed on embryos produced through in-

57
vitro fertilisation. ”
H. Because the restrictions provided in the ART Act
as regards oocyte donors pose many questions on
its implementation and viability. Under
Section27(4) of the ARTA ct, an oocyte donor can
donate only once in her life time. This implies that
the number of egg donors will be totally
restricted, which will only result in a huge
wastage of oocytes and an astronomical increase
in costs and waiting time. Furthermore, while
sperm quality can be tested through a simple
semen analysis, there is no test as of date to
check the quality of eggs, thereby making this
provision impracticable and expensive, for the
middle and lower classes.
I. Because the aforesaid provision seems to have
been incorporated without proper application of
mind and without taking into account a woman‟s
basic physiology. There there is enough research
to show that oocyte donation is safe, devoid of any

58
long-term effects on the donor‟s fertility or life
span and does not entail removal of an organ.
According to a recent study conducted by the
American Society of Reproductive Medicine, that
egg donors who undergo up to six cycles do not
have any evidence of depleting their ovarian
reserve, which bodes well for their future fertility.
While women are born with a finite number of
eggs (with about 300,000 left at puberty), the
overwhelming majority of those eggs will die
without being used, and only about 300 to 400 will
be ovulated. Donating eggs requires a very small
fraction of that reserve, and the ovary stimulation
process makes use of some of the eggs that would
die off anyway. In fact, as per research, women
can typically donate eggs up to six times as long
as they are clinically approved for repeat
procedures. This number was also approved by
the ICMR and was followed by IVF practitioners
till the passing of the impugned Act.

59
J. Because it is pertinent to mention here that oocyte
donation is not like liver and kidney
transplantation where organs are to be removed.
Oocytes are aspirated every month during a
natural menstrual cycle of a woman so retrieving
oocytes from an egg donor does not have any
short or long-term adverse effects on the female
body. Another analogy can be drawn with blood
donation, which is altruistic vis-à-vis oocyte
donation. It is important to take into consideration
that oocyte donation is not the same as blood
donation. While blood donation requires some 60
minutes, egg donation is a process which takes 2
weeks, multiple visits to the clinics as well as
daily injections. Furthermore, most patients do
not have a younger sister or friend who would be
willing to donate oocytes altruistically, and
therefore would inevitably need a donor from the
ART bank, which will be extremely restricted
owing to the requirement provided under Section
27(2) of the ART Act and the unavailability of ART

60
banks at present. The aforesaid provision is
thusviolative of a woman‟s reproductive rights
which have been time and again recognized by
the Hon‟ble Supreme Court as being an essential
component of the right to life under Article 21 of
the Constitution.
K. Because there is no scientific basis for cutting
down the number of egg donations from 6 (as
allowed by ICMR guidelines) to just one in an
entire lifetime of a donor. The scientific basis for
allowing 6 donations is to reduce the risk of
consanguinity in the general population and
reduce the cumulative risk involved to a donor by
repeated egg donations.
L. Because additionally, the screening process that
egg donor undergo to determine their eligibility
provides information about their fertility, which
can help them plan for their own family
building in the future and hence is beneficial for
them even in that sense.

61
M. Because in current practice, especially with the
long waiting and difficulties with adoption,
embryo donation remains one of the most cost
effective and successful modalities of treating
couples who have failed IVF or cannot afford
repeated cycles. There would be a great increase
in treatment costs and huge shortage of donors if
an oocyte donor is allowed to donate only once, if
the oocytes are to be used for only one recipient
and if only 7 oocytes are to be retrieved, as is
provided under Section 27(4) of the Act. This
would put IVF with oocyte donation (which is
required by almost 40% of patients in any IVF
clinic) out of reach of the entire middle and lower
income group of patients (there would be almost
1.5-2 Crore patients who require egg donation at
a reasonable and affordable budget). Thus the
aforesaid provision creates an artificial distinction
between childless couples on the basis of their
economic status, making it violative of Article 14
of the Constitution.
62
N. Because furthermore, even with the lowest of
doses for ovarian stimulation most donors would
yield about 10-20 oocytes which is medically
proven to be required for a successful in-vitro
fertilization. Most successful pregnancies require
2-3 cycles. Hence the aforesaid requirement
under Section 27(4) of the ART Act of extracting
only seven oocytes is medically impossible to
achieve, which will result in bringing third party
donor cycles to a standstill.
O. Because imposing restrictions on an oocyte
donor‟s right to donate her eggs for the benefit of
another childless couple is a violation of
reproductive autonomy of women as laid down by
this Hon‟ble Court in a catena of judgments
including the choice to donate her eggs to help
infertile couples start a family. Such a restriction is
ultra virus as being violative of Articles 14 and 21
of the Constitution of India. It is strange that while
there is no restriction on the number of children

63
that a couple can bear, nor is there a “One Child
Policy” in India, restrictions have been imposed
on the number of oocyte donations.
P. Because in the case of Gobind v. State of
M.P.,(1975) 2 SCC148, this Hon‟ble Court stated
that “nothing would advance women's welfare
more than respecting their reproductive
autonomy. Such autonomy must encompass and
protect the personal intimacies of marriage,
motherhood, procreation, and child-rearing”.
That thereafter in in Suchita
Srivastava v. Chandigarh Admn.(2009) 9 SCC 1,
this Hon‟ble Court observed that a woman's right
to make reproductive choices has been
interpreted as a dimension of “personal liberty”
as understood under Article 21 of the Constitution
of India. Further, in Devika Biswas v. Union of
India, (2016) 10 SCC 726 the Hon‟ble Supreme
Court held that the right to reproduction is an
important component of the “right to life” under
Article 21. Reproductive rights of a woman

64
include the right to carry a baby, give birth, and
raise children. Rights to privacy, dignity, and
integrity are also included.Hence, the above
judgments indicate that a woman's right to make
a reproductive choice is a part of her liberty
under Article 21. Thus imposing a restriction on
egg donors and lack of monetary compensation
for egg donation is in stark violation of
reproduction autonomy of women.
Q. Because a nine-judge bench of this Hon‟ble Court
in K S Puttaswamyv. Union of India, recognized
the right to privacy as a constitutionally protected
right under Article 21 of the Constitution. In
Puttaswamy(supra), this Court held that the right
to privacy enables individuals to retain and
exercise autonomy over the body and mind. The
autonomy of the individual was defined as “the
ability to make decision on vital matters of
concern to life.”The judgement delivered on
behalf of four judges described the right to
privacy in the following terms:

65
“297. ... Privacy postulates the reservation of a
private space for the individual, described as the
right to be let alone….The ability of an individual to
make choices lies at the core of the human
personality. The notion of privacy enables the
individual to assert and control the human element
which is inseparable from the personality of the
individual. The inviolable nature of the human
personality is manifested in the ability to make
decisions on matters intimate to human life. The
autonomy of the individual is associated over
matters which can be kept private. These are
concerns over which there is a legitimate
expectation of privacy. The body and the mind are
inseparable elements of the human personality. The
integrity of the body and the sanctity of the mind can
exist on the foundation that each individual
possesses an inalienable ability and right to
preserve a private space in which the human
personality can develop. Without the ability to make
choices, the inviolability of the personality would be

66
in doubt.”
R. Because more recently, this Hon‟ble Court has
most recently in X. v. Principal Secretary, 2022
SCC Online SC 905 has discussed the wide ambit
of the right to reproductive autonomy. The same is
quoted hereinbelow:
“96. The ambit of reproductive rights is not
restricted to the right of a woman to have or not
have children. It also includes the constellation of
freedoms and entitlements that enable a woman to
decide freely on all matters relating to her sexual
and reproductive health. Reproductive rights
include the right to access education and
information about contraception and sexual health,
the right to decide whether and what type of
contraceptives to use, the right to decide whether
and what type of contraceptives to use, the right to
choose whether and when to have children, the
right to choose the number of children, the right to
access safe and legal abortions, and the right to
reproductive healthcare. Women must also have

67
the autonomy to make decisions concerning these
rights, free from coercion or violence.”
LACK OF MONETARY CONSIDERATION FOR
OOCYTE DONORS:
S. Because Section 22(1)(b) of the ART Act provides
for an insurance coverage for an oocyte donor for
a period of 12 months. Section 22 is reproduced
hereinbelow:
(1) The clinic shall not perform any treatment or
procedure without— (a) the written informed
consent of all the parties seeking assisted
reproductive technology;
(b) an insurance coverage of such amount as may
be prescribed for a period of twelve months in
favour of the oocyte donor by the commissioning
couple or woman from an insurance company or an
agent recognised by the Insurance Regulatory and
Development Authority established under the
provisions of the Insurance Regulatory and
Development Authority Act, 1999.
(2) The clinics and banks shall not cryo-preserve

68
any human embryos or gamete, without specific
instructions and consent in writing from all the
parties seeking assisted reproductive technology,
in case of death or incapacity of any of the parties.
(3) The clinic shall not use any human reproductive
material, except in accordance with the provisions
of this Act to create a human embryo or use an in-
vitro human embryo for any purpose without the
specific consent in writing of all the concerned
persons to whom the assisted reproductive
technology relates.
(4) Any of the commissioning couple may withdraw
his or her consent under sub-section (1), any time
before the human embryos or the gametes are
transferred to the concerned woman's uterus.
Explanation.—For the purposes of this section, the
expressions— (i) "cryo-preserve" means the
freezing and storing of gametes, zygotes, embryos,
ovarian and testicular tissues;
(ii) "insurance" means an arrangement by which a
company, individual or commissioning couple

69
undertake to provide a guarantee of compensation
for specified loss, damage, complication or death of
oocyte donor during the process of oocyte retrieval;
and
(iii) "parties" includes the commissioning couple or
woman and the donor.
It is submitted that while there is a provision of
insurance coverage for the oocyte donor, the Act
does not have a provision for any kind of
monetary consideration for oocyte donors. The
lack of any provision for consideration is a major
oversight of the rights of egg donors and the fact
thatan egg donor would lose time from work and
entail some expenditure on medical, travel, loss
of time, loss of wages and hence should be aptly
compensated in money for undergoing a surgical
procedure of egg retrieval. Moreover, while the
objective of the Act is to prevent commercial
transactions leading to monetary gains in favour
of egg donors, it nowhere debars an egg donor
from receiving reimbursement for expenses

70
incurred even though it does not expressly
provide for the same, making it open to judicial
scrutiny.
T. Because the decision of an adult consenting
woman to donate oocytes is a part of the
reproductive rights guaranteed to women under
Article 21 of the Constitution and has been upheld
by the Hon‟ble Supreme Court time and again in a
catena of judgments. That oocyte donation to
childless couples for IVF cycles is nothing short
of a noble task and hence introducing some
element of compensation would not make it any
less noble. In fact such compensation should be
viewed as a recognition and reward for the time,
effort and potential health hazards that an egg
donor agrees to subject herself to, in order to
bring a ray of hope for a childless couple.
U. Because as per studies conducted in some major
developing countries of the world, there is a
presumption that compensation to individuals for

71
reproductive and other tissues is inconsistent with
maintaining important values related to respect
for human life and dignity. Arguably, this view is
reflected in laws prohibiting direct compensation
to individuals providing organs and tissues for
transplantation. Yet, such laws generally permit
organ and tissue donors to receive
reimbursement for expenses and other costs
associated with the donation procedure. These
facts support the compensation of oocyte donors
as well. That in countries like UK, egg donors are
allowed compensation of upto £750 per donation
„cycle‟ to cover their costs (a donation cycle is
one complete round of treatment, at the end of
which the eggs are collected and donated), and
any further expenses for travel, accommodation
and childcare. A similar provision should be
brought about in India laws, considering it would
be almost impossible to find an egg donor without
any consideration whatsoever, bringing third
party donor cycles to a standstill.

72
V. Because Section 2(e) defines "commissioning
couple" as any infertile married couple who
approach an assisted reproductive technology
clinic or assisted reproductive technology bank
for obtaining the services authorised of the said
clinic or bank. Thus there is no bar on foreign
commissioning couples to avail ART services,
thereby allowing the government to benefit from
international medical services. This is likely to
increase demand for ART services and drive up
the prices, as foreign commissioning couples
arguably have the resources to bear high tariffs
put in place by private clinics. Meanwhile, the
sector seeks to rely on the altruism of gamete
donors, which will reduce the supply of gametes,
thereby producing a shortage in gamete supply.
This will result in higher prices for gametes,
which is highly likely to incentivise an
underground market in gametes. In the absence
of pricing regulation for ART clinics and banks,
these organisations will continue to grow

73
unbridled such that only the wealthiest can access
ARTs excluding millions from non-elite socio-
economic groups who aspire to form families.
Meanwhile, oocyte donors will continue to be
devalued, uncompensated and unprotected as
underground markets for egg donors and
surrogacy thrive. Hence the aforesaid provision is
violative of an egg donor‟s constitutional rights
under Article 14 and 21 of the constitution.
BAN ON TRANSFER OF DONOR EMBRYOS:
W. Because Section 29 of the ART Act prohibits sale,
transfer or use of gametes, zygotes and embryos,
to any party within or outside India except in the
case of transfer of own gametes and embryos for
personal use with the permission of the National
Board. It reads as follows:
29. The sale, transfer or use of gametes, zygotes
and embryos, or any part thereof or information
related thereto, directly or indirectly to any party
within or outside India shall be prohibited except in
the case of transfer of own gametes and embryos for

74
personal use with the permission of the National
Board.
Explanation.—For the purposes of this section, the
expression "zygote" means the fertilised oocyte
prior to the first cell division.
X. Because such a prohibition on transfer of embryos
obtained out of third party donor gametes under
Section 29 of the ART Act has made it impossible
for couples to avail ART Servicesusing embryos
which have been frozen prior to the passing of the
ART Act. In the absence of transitory provisions
and in the absence of setting up State Boards in
most states of India, commissioning couples are
facing huge difficulties in procuring such frozen
embryos for continuation of IVF procedures. The
intention of the legislature is to prevent/restrict
sale of human gametes but such blanket ban on
third party embryo transfer for IVF is causing
unnecessary difficulties for commissioning
couples in availingART services which is neither
desirable not in consonance with the object

75
sought to be achieved by the Act. In fact many
couples are approaching different High Courts for
transfer of frozen embryos, which in addition to
leading to multiplicity of litigation, is causing
unnecessary harassment, wastage of time and
money as well as disclosure of their identities,
which is an infringement of their right to privacy
under Article 21.
Y. Because in a recent judgment passed on
21.06.2022 by the Hon‟ble Kerala High Court in a
Writ Petition being W.P.(C) No.19184 of
2022wherein a couple challenged the denial by
one hospital to transfer embryos to another
hospital of the couple„s choice as being barred
under Section 29 of the ART Act, the Learned
Single Judge while allowing the transfer of the
said embryos to the hospital of the couple„s
choice held as follows:
“In my considered opinion, Section 29 does not
interdict such transfer. A close scrutiny of the
provision shows that the intention is to

76
prevent/restrict sale etc. of human gametes,
zygotes and embryos. In the case at hand, there
is no such transfer, since no donor or third party
is involved and the embryos are that of the
commissioning couple. Apart from the
aspirations of the first petitioner to conceive and
the second petitioner, to beget a child, the right
of the life inside the embryo, which is kept frozen
for the past 8years, to develop into a foetus and
be born, cannot be stultified by relying on a
provision which has no application. The primary
objective of the Act is the regulation and
supervision of the assisted reproductive
technology clinics and banks, by preventing
misuse and ensuring safe and ethical practice of
assisted reproductive technology services. The
Act is not intended to create difficulties for
persons opting assisted reproductive
procedure.”
ARBITRARY AGE RESRICTION FOR COUPLES
AVAILING ART SERVICES:

77
Z. Because Section 21(g) of the ART Act States as
follows:
21(g). The clinics shall apply the assisted
reproductive technology services,
(i) to a woman above the age of twenty-one
years and below the age of fifty years;
(ii) to a man above the age of twenty-one years and
below the age of fifty-five years;
That there is no rationale for having such
restrictions on the basis of age to avail IVF. In fact
with the advancement in science and technology,
there has been some modification in the natural
limits of reproduction for women and with the help of
hormonal treatments and donation, women who have
achieved menopause can also pursue pregnancy.
According to The Indian Council of Medical
Research (ICMR) guidelines of 2005, the woman
carrying the baby “should be a healthy woman
(determined by medical and psychological

78
examination) having normal genitalia (as determined
by physical examination).” Therefore, the aforesaid
provision of the ART Act and is contrary to the
guidelines of 2005 of ICMR. It is submitted that the
ICMR is specialized body who has issued guidelines
taking note of ground realities. Hence, there seems
to be no justification to make provisions contrary to
and in violation of such guidelines.
AA. Because even as per the guidelines of the Ministry
of Health, Government of India, 2005, when it
comes to reception of donated embryos, there was
no upper age limit for IVF in India. Similarly, there
is no official age limit for IVF treatment in the
United Kingdom. However, it is not recommended
to attempt IVF over the age of 45 years usingones
own eggs, as very few women conceive and have a
baby using their own eggs at that age. However, in
the case of use of donor eggs from a younger
female, there are no such risks involved and hence
such age restriction is completely unjustified. In
fact the decision to conduct an IVF procedure on a

79
patient should lie with the medical practitioners
depending on the health risks involved and should
be treated as contract between the doctor and
patient.
BB. Moreover, since IVF is not funded by the
government, they have no locus to bring about age
restrictions in an arbitrary fashion. It is therefore
humbly submitted that the decision on part of the
legislature to set age limits by way of Section 21(g)
of the ART Act is absolutely unreasonable and
arbitrary. In fact, the State under the garb of
regulating ART processes is exercising pervasive
control over family domains of its citizens, which is
a direct infringement of Article 21 of the
Constitution.
CC. Because there is no rationale for having different
age limits for availing ART and surrogacy services.
It is undeniable that there can be no surrogacy
without ART. While a woman is eligible to opt for

80
ART services (i.e., if using her own eggs) at 21
years, she can opt for surrogacy only when she is
23 years. Moreover, while single women can avail
of ART services, she cannot go in for surrogacy.
The situation is worse for a widow or a divorcee
who can opt for surrogacy only after she has
attained 35 years of age. The ART Act is the
umbrella legislation under which surrogacy also
operates and such inconsistencies between the
two acts are bound to create implementation
difficulties thus negating the object of the Acts.
MANDATORY COLLECTION OF DONOR GAMETES BY
A DONOR BANK:
DD. BECAUSE section 21(b) r/w 27(1) of the ART Act,
2021 provides for screening, collection and
storage of semen and oocyte provision only by a
bank, and not by an ART clinic:
21. The clinics and banks shall perform the following
duties, namely:— (a) the clinics and banks shall

81
ensure that commissioning couple, woman and
donors of gametes are eligible to avail the assisted
reproductive technology procedures subject to such
criteria as may be prescribed;
(b) the clinics shall obtain donor gametes from the
banks and such banks shall ensure that the donor
has been medically tested for such diseases as may
be prescribed;
27. (1) The screening of gamete donors, the
collection, screening and storage of semen; and
provision of oocyte donor, shall be done only by a
bank registered as an independent entity under the
provisions of this Act.
However, with the advent of ART Clinic Rules
which were notified on 07.06.2022, the functions of
ART Banks have been further classified. The same
is reproduced hereinbelow
Rule 3: Assisted Reproductive Technology (ART)
clinics and banks.- (1) These shall be two levels of
clinics, namely:-
82
EE. (i) Level 1 ART Clinics, where only intrauterine
insemination (IUI) procedure is carried out as part
of treatment;
(ii) Level 2 ART clinics, where the procedures, or
as the case may be, techniques, that attempt to
obtain a pregnancy shall be carried out by any or
all of the following, namely:-
(a) surgical retrieval of gametes;
(b) handling the oocyte outside the human
body;
(c) use sperms for fertilization of oocytes;
(d) transfer of the embryo into the reproductive
system of a woman;
Provided that such clinics may also undertake
research.
(2). ART banks shall-
(i) be responsible for screening, collection
and registration of the semen donor and

83
cryopreservation of sperms;
(ii) perform screening and registration of oocyte
donor;
(iii) operate as semen banks or oocyte banks or
both;
(iv) maintain the records or data of all the donors
and shall regularly update the National Registry as
provided in sections 23, 27, 28 of the Act.
FF. Because after the coming into force of the ART
Rules, the ART banks have been merely reduced
to an egg donor registry, recruiting donors and
sending them to ART clinics, which is an
unnecessary procedural roadblock serving no
legitimate purpose. There seems to be no rational
basis of having separate ART Banks and ART
Clinics. Moreover, when the identity of the donor
is already known, the ART Banks have no real
function and the entire process of recruiting
donors and carrying out IVF can be done by ART
clinics themselves. In factwith the present dual set

84
up, the ART Banks have little or no accountability
and have become a source of corruption and the
ART Clinics are being penalized for the mistakes
done by ART Banks. A better recourse would be to
have the ART Banks housed in ART Clinics. In this
way the entire responsibility and accountability
shall fall on ART Clinics which in turn will help in
streamlining of the entire process of donor egg
recruitment, which is the object of the legislature
for enacting the said provision.
GG. Because although the object of the legislature is to
streamline and regulate the process of Assisted
Reproduction, the mandatory provision of gamete
collection by an ART Bank makes the entire
process of obtaining donor gametes more
complicated and expensive and hence is not in
consonance with the object and purpose of the Act.
HH. Because since no such ART banks have been
approved till date, it is impossible for clinics to
carry out donor cycles despite having the

85
available donors, due to the procedural
obstruction created by insertion of Section 27(1)
and Section 21(b) of the ART Act alongwith Rule 3.
Such a roadblock is adding to the problems of
couples desirous of having a baby through third
party donor eggs.
EXCLUDES SAME SEX COUPLES AND LIVE-IN
COUPLES:
II. Because Section 2(1) (e) defines a "commissioning
couple" as follows:
a. “Commissioning couple means an infertile
married couple who approach an assisted
reproductive technology clinic or assisted
reproductive technology bank for obtaining
the services authorised of the said clinic or
bank”. The definition of commissioning
couples excludes from within its ambit same
sex couples as well as live in couples creating
discrimination between individuals on the
basis of their sex and marital status which is

86
against the spirit of the constitution as well as
some landmark judgments delivered by this
Hon‟ble Court as elaborated in the succeeding
paragraphs.
JJ. Because the ART Act restricts right of availing
artificial reproductive technologies only to
commissioning couple i.e. an infertile married
couple, as defined u/s 2(1)(e) and woman as
defined u/s 2(1)(u). It is submitted while the
relatively broad definition of “woman” in 2(1)(u)
may allow a single woman to avail the options
under the ART Act, these restrictive definitions
entirely side step live-in couples, even though a
woman in live-in relationship had all rights
available to any other woman under other laws
including with regards maintenance, domestic
violence and medical termination of pregnancy.
KK. Because the Act completely ignore the rights of a
single man to have a child by availing any of the
assisted reproductive techniques including

87
surrogacy. It is pertinent to mention here that
section 7 of the Hindu Adoptions and Maintenance
Act, 1956 expressly permits a Hindu male of sound
mind, and who is not a minor, to adopt. Similarly,
there exist no restrictions in other personal laws
from individual men of sound mind to have
children. However, the impugned legislation fail to
provide for a man to have children to assisted
techniques.
LL. Because the ART Act also envisages within its
scope a “married couple”, while other progressive
legislations such as recently amended Medical
Termination of Pregnancy Act recognized a woman
and her “partner”. This Hon„ble Court in X v.
Principal Secretary, Health and Family Welfare
Department &Anr, while interpreting the Medical
Termination of Pregnancy Act has held that the use
of the term “partner” shows parliamentary
intention to recognize situations beyond
matrimonial relationship and to recognize
reproductive choice of a woman as also her bodily

88
integrity and autonomy.
It is submitted that in this transformative
constitutional era that is marching toward the
ideals of liberty and equality, these loopholes
would be constitutional hurdles.
MM. BECAUSE the ART Act fixes the minimum age for a
woman to access ARTs at 21, rather than linking it
to the age at marriage. Thus, single women who
are unmarried, divorced or separated can access
ARTs. Yet, when those very women enter into
relationships (that is, as live-in couples or same-
sex couples), their rights cease to be of
consequence making the Act is self contradictory
and discriminatory and alters women‟s
reproductive rights according to their relationship
status. “The social condition of childlessness is
thus constructed as a “problem” towards which
ARTs are to be geared, albeit selectively.
Technology is prevented from being used to
redefined families or imagine any alternatives.

89
Rather, it is viewed as a mere instrument to
reproduce in a manner licensed by patriarchy.”
(Regulating Reproductive Technologies- Sneha
Bannerjee and Pratibha Kotiswaran)
NN. Because the ART Act disentitles same-sex couples
from commissioning IVF is also in violation of the
decision of this Hon„ble Court in Navtej Singh Johar
v. Union of India (2018 10 SCC 1) whereby
recognition and legitimacy were granted to same-
sex couples even though same-sex marriage is still
to be recognized.
OO. Because this Hon„ble Court had held in Navtej
Singh Johar case (supra),
“108. The concept of transformative
constitutionalism has at its kernel a pledge, promise
and thirst to transform the Indian society so as to
embrace therein, in letter and spirit, the ideals of
justice, liberty, equality and fraternity as set out in
the Preamble to our Constitution. The expression
transformative constitutionalism„ can be best

90
understood by embracing a pragmatic lens which
will help in recognizing the realities of the current
day. Transformation as a singular term is
diametrically opposed to something which is static
and stagnant, rather it signifies change, alteration
and the ability to metamorphose. Thus, the concept
of transformative constitutionalism, which is an
actuality with regard to all Constitutions and
particularly so with regard to the Indian
Constitution, is, as a matter of fact, the ability of the
Constitution to adapt and transform with the
changing needs of the times.
116. Equality does not only imply recognition of
individual dignity but also includes within its sphere
ensuring of equal opportunity to advance and
develop their human potential and social, economic
and legal interests of every individual and the
process of transformative constitutionalism is
dedicated to this purpose. It has been observed by
Albertyn & Goldblatt:-
"The challenge of achieving equality within this

91
transformation project involves the eradication of
systemic forms of discrimination and material
disadvantage based on race, gender, class and
other forms of inequality. It also entails the
development of opportunities which allow people to
realise their full human potential within positive
social relationships."
128. It is the concept of constitutional morality which
strives and urges the organs of the State to maintain
such a heterogeneous fibre in the society, not just in
the limited sense, but also in multifarious ways. It is
the responsibility of all the three organs of the State
to curb any propensity or proclivity of popular
sentiment or majoritarianism. Any attempt to push
and shove a homogeneous, uniform, consistent and
a standardised philosophy throughout the society
would violate the principle of constitutional morality.
Devotion and fidelity to constitutional morality must
not be equated with the popular sentiment prevalent
at a particular point of time.”

92
PUNISHMENT PRESCRIBED FOR MEDICAL
PRACTITIONERS IS EXTREMELY ONEROUS AND
UNJUSTIFIED:
PP. Because Section 33 of the ART Act prescribes a
penalty of Rs. 5 lakhs to upto 20 lakhs, as well as
imprisonment for medical practitioners, who are
found in contravention of the provisions
prescribed therein, which is unheard of , and will
pose to be a serious deterrent discouraging
doctors from performing their professional duties.
Section 33 of the ART Act is quoted here in below:
33.(1)Any medical geneticist, gynaecologist,
registered medical practitioner or any person shall
not- (a) abandon, disowner exploiter cause to be
abandoned, disowned or exploited in any form the
child or children born through assisted reproductive
technology; (b) sell human embryos or gametes, run
an agency, aracke to ran organisation for selling, 73
purchasing or trading in human embryos or
gametes; (c) import or help in getting imported in

93
what so ever manner, the human embryos or human
gametes; (d) exploit the commissioning couple,
woman or the gamete donor in any form; (e) transfer
human embryo into a male person or an animal; (f)
sell any human embryo or gamete for the purpose of
research; or (g) use any intermediates to obtain a
gamete donors or purchase gamete donors.
(2) Whoever contravenes the provisions of
clauses (a)to(g)of subsection (1), shall be
punishable with a fine which shall not be less than
five lakh rupees but may extend to ten lakh rupees
for the first contravention and for subsequent
contravention, shall be punishable with
imprisonment for a term which shall not beless than
three years but may extend to eight years and with
fine which shall not be less than ten lakh rupees but
may extend to twenty lakh rupees.
That the aforesaid provision is extremely harsh
and will have the effect of discouraging doctors
from undertaking IVF procedures. It is pertinent to

94
mention here that no other country in the world has
such a harsh punishment for medical practitioners.
QQ. Because medical complications or grievances
arising from the technical part of the various
procedures already come under the purview of
Medical Council of India Consumer Court / Civil
Court, and the same should be applicable to IVF
practitioners under the ART Act. Bringing the IVF
practitioners within the purview of the IPC would
create unnecessary fear amongst medical
practitioners.
RR. Because this Hon‟ble Court in the recent landmark
judgment of X vs. Principal Secretary Health and
Family Welfare (MTP Judgment) has made certain
glaring observations as regards the cascading
effects of fear of prosecution amongst registered
medical practitioners. The relevant extract is
quoted hereinbelow:
“20. Presently, under the MTP Act, the opinion

95
of an RMP (in accordance with the restrictions and
grounds laid down in the Act) is decisive. It is on the
basis of the opinion formed by RMP(s), either under
Section 3 or under Section 5, that a woman can
terminate a pregnancy under the MTP Act. This
makes the MTP Act a provider-centric law. Since
women’s right to access abortion is conditional on
the approval by an RMP, the denial of services by an
RMP compels women to approach courts or seek
abortions in unsafe conditions.A fear of prosecution
under this complex labyrinth of laws, including
linking of the MTP Act with the IPC, acts as a major
barrier to safe abortion access, by having a chilling
effect on the behaviour of RMPs. The chilling effect
— historically associated with protection of freedom
of speech and expression under Article19— has an
impact on the decision-making of medical
professionals acting under the MTP Act and
consequently impedes access to safe and legal
abortions and the actualization of women’s
fundamental right to reproductive autonomy.

96
21. In Navtej Singh Joharv. Union of India a
Constitution Bench of this Court held that Section
377 had a chilling effect on the exercise of freedom
of individuals, which posed a grave danger to the
unhindered fulfilment of one’s sexual orientation, as
an element of dignity and privacy. One of us, Dr. DY
Chandrachud, J., recognized the impact of the
criminalization of homosexuality on the spread of
HIV/AIDS and how fear of prosecution and stigma
created barriers to accessing HIV prevention
services, in his concurring opinion. This Court
observed that:
“508. The silence and secrecy that accompanies
institutional discrimination may foster conditions
which encourage escalation of the incidence of
HIV/AIDS. The key population is stigmatized by
health providers, employers and other service
providers. As a result, there exist serious obstacles
to effective HIV prevention and treatment as
discrimination and harassment can hinder access to

97
HIV and sexual health services and prevention
programmes.”
22. Although the actions of RMPs done in good
faith under the MTP Act are protected under Section
8, the spectre of criminalization casts a chilling effect
on them. The fear faced by RMPs of prosecution
under the penal provisions often leads to
unnecessary delays. It is a common yet lamentable
practice for RMPs to insist on compliance with extra-
legal conditions such as consent from the woman’s
family, documentary proofs, or judicial
authorisation. If the woman fails to comply with these
additional requirements, RMPs frequently decline to
provide their services in conducting legal
abortions.”
SS. Because prescribing the punishment under
Section 33 of the ART Act as being a cognizable
offence is extremely harsh for medical
practitioners and would have a chilling effect on
doctors bringing the entire IVF sector to a

98
standstill. Offences are of a cognizable nature
usually when they are heinous in nature and in
view of the same, applying the same to doctors
and ART clinics is extremely unjustified and in a
way treats medical professionals as criminals and
hence is in violation of freedom of speech and
expression under Articles 19 and freedom of life
under Article 21 of the constitution.
TT. Because this Hon‟ble court has recently issued
notice in a PIL titled Arun Muthuvel vs. Union of
India, challenging several provisions of the
Surrogacy(Regulation) Act, 2021 as well as the ART
(Act) 2021 as well as the corresponding rules
framed therein. That the issues under challenge in
the present Writ Petition are connected to the
issues raised in the aforementioned PIL and hence
require the kind consideration of this Hon‟ble
Court for complete justice.
UU. Because Petitioners have no other alternative and
efficacious remedy other than approaching this

99
Hon‟ble Court under Artcile 32 of the constitution
and the petitioners as representative of their
patients as well as in their personal capacity will
suffer an irreparable injury and harm if the relief
prayed for is not granted.
VV. Because the balance of convenience lies in favour
of the Petitioners.
WW. The Petitioner craves leave of this Hon‟ble Court to
add/modify the contentions and prayers at the
time of arguments
28. The Petitioners have not filed any other similar writ
petition before this Hon‟ble Court or before the Hon‟ble
High Courts for similar reliefs.
29. That the petitioners have not approached any of the
respondent or other authority for similar relief.
PRAYERS:
A) Issue a writ in the nature of mandamus of any other
appropriate writ, direction or order to strike down
Section 27(4) of the ART Act as being violative of

100
reproductive autonomy of woman and hence
unconstitutional;
B) Issue an appropriate writ, direction or order to direct
the Central government to make a specific provision
for monetary consideration to egg donors apart from
insurance coverage provided under the Act, to cover
for the loss of time, loss of job, transportation costs
and additional incidental expenses.
C) Issue a writ in the nature of mandamus of any other
appropriate writ, direction or order to direct the
Central Government to allow transport of Frozen
Gametes (Oocytes/Sperms) and Embryos (other than
own) within the country on a case to case basis after
due discussion with State Board.
D) Issue an appropriate writ, direction or order reading
down the provision of Section 21(b) of the ART Act, to
allow IVF clinics to do donor cycles themselves,
instead of mandating an IVF bank to be involved in
the process;
101
E) In the alternative, Issue an appropriate writ,
direction or order to have ART banks housed in ART
Clinics, shifting the entire responsibility on ART
Clinics for better accountability.
F) Issue a writ in the nature of mandamus or any other
appropriate writ, direction or order to strike down
Section 21(g) of the ART Act imposing unreasonable
age restrictions on couples availing ART services in
case of third party donations as unconstitutional;
G) In the alternative, issue an appropriate writ, direction
or order reading down Section 21(g) of the ART Act
so as to leave it to the discretion of the doctor based
upon the health condition of the woman in need of
ART services.
H) Issue an appropriate writ, direction or order to direct
the Central government to bring insurance for egg
donors and infertile couples under the Aayushman
Bharat Scheme to make it affordable, as WHO has
now classified infertility as a disease and not a
disorder;
102
I) Issue an appropriate writ, direction or order to direct
the Central government to issue clarification about
the insurance policy which is to be procured for egg
donors and further direct the DHR/appropriate
authority to request IRDA to issue a circular to
insurance companies to develop insurance covers
for the infertile couples as well as donors as per the
requirement of the Act.
J) Issue an appropriate writ, direction or order striking
down the provision of Section 2(1)(e) of the ART Act
as it is discriminatory on grounds of sex and marital
status and hence unconstitutional;
K) Issue an appropriate writ, direction or order to strike
down the Section 33 of the ART Act prescribing
stringent penalties and imprisonment for medical
practitioners and bringing them within the purview
of the IPC as unconstitutional;

103
AND FOR THIS ACT OF KINDNESS YOUR HUMBLE
PETITIONERS AS IN DUTY BOUND SHALL EVER PRAY.
DRAWN & FILED BY
(MOHINI PRIYA)
ADVOCATE FOR THE PETITIONER
Drawn On: 24.11.2022
Filed On: 03.12.2022

104
IN THE SUPREME COURT OF IN DIA
CML ORIGINAL JURISDICTION
WRIT PETITION (CML) N O. OF2022

IN THE MATTER OF:
Aniruddha N arayan Malpani & Ors. . .. Petitioners
VERSUS
Union of India & Ors. . .. Respondents
AFFIDAVIT
I, Aniruddha Narayan Malpani, S/o. Narayan Malpani age about
61 years Rio. Flat No. 604, Jamuna Sagar, 6th Floor, Shahid
Bhagat Singh Road, Colaba Bus Station, Colaba, Murnbai-400005
(Maharashtra) presently at Mumbai do hereby solemnly affirm
and declare as follows:
1. That I am one of the Petitioner in the above mentioned Writ

Petition and duly authorized by the other petitioners, I am
well conversant with the facts and circumstances of the
present case and as such competent to swear this affidavit.
2. I state that I have read and understood the contents of the

accompanying Writ Petition from Para 1 to _29 pages 1 to
_
105, Synopsis & List of Dates from Pages B to _P as have
been drafted under my instruction and that I have read

and understood the same and that I state that the facts
stated therein are true to the best of my knowledge and
belief and rest are submissions based on legal advice
which I believe to be true and correct.
105
3. I say that the Annexures annexed along with the Writ
Petition are true copy of its respective original.
3. I say that the averments of facts stated herein above are

true to my knowledge, no part of it is false and nothing
material has been concealed therein.
W-A..CJv-i~~\
DEPON EN T
VERiflCATION :
I, the deponent above named do hereby verify that the contents
of the above affidavit are true to my knowledge, no part of it is
false and nothing material :t:tas been concealed therefrom.
.. ,.~ii , \ .
Verified at ~'-l. i; on this day of November, 2022.
i hi
° ' M ~ ~ ~·
DEPON EN T
aE O~f,~
__.;,..,_.iJU..,1~~~100
_ _ _OTARY JlJ~ \ \\ \,ryz_
Government of lnd'ra
M~m~ai & Thane Dist
. 2 4 NOV 2021/.
NOTED & REGI JERED

Sr. N .... .... Page N .• • : ..
Annexure P/1
106
Convention on the Elimination of All Forms of Discrimination against Women
Adopted and opened for signature, ratification and accession by General Assembly
resolution 34/180 of 18 December 1979
entry into force 3 September 1981, in accordance with article 27(1)
The States Parties to the present Convention,
Noting that the Charter of the United Nations reaffirms faith in fundamental human rights, in the
dignity and worth of the human person and in the equal rights of men and women,
Noting that the Universal Declaration of Human Rights affirms the principle of the inadmissibility of
discrimination and proclaims that all human beings are born free and equal in dignity and rights and
that everyone is entitled to all the rights and freedoms set forth therein, without distinction of any
kind, including distinction based on sex,
Noting that the States Parties to the International Covenants on Human Rights have the obligation to
ensure the equal rights of men and women to enjoy all economic, social, cultural, civil and political
rights,
Considering the international conventions concluded under the auspices of the United Nations and the
specialized agencies promoting equality of rights of men and women,
Noting also the resolutions, declarations and recommendations adopted by the United Nations and the
specialized agencies promoting equality of rights of men and women,
Concerned, however, that despite these various instruments extensive discrimination against women
continues to exist,
Recalling that discrimination against women violates the principles of equality of rights and respect for
human dignity, is an obstacle to the participation of women, on equal terms with men, in the political,
social, economic and cultural life of their countries, hampers the growth of the prosperity of society
and the family and makes more difficult the full development of the potentialities of women in the
service of their countries and of humanity,
Concerned that in situations of poverty women have the least access to food, health, education,
training and opportunities for employment and other needs,
Convinced that the establishment of the new international economic order based on equity and justice
will contribute significantly towards the promotion of equality between men and women,
Emphasizing that the eradication of apartheid, all forms of racism, racial discrimination, colonialism,
neo-colonialism, aggression, foreign occupation and domination and interference in the internal affairs
of States is essential to the full enjoyment of the rights of men and women,
Affirming that the strengthening of international peace and security, the relaxation of international
tension, mutual co-operation among all States irrespective of their social and economic systems,
general and complete disarmament, in particular nuclear disarmament under strict and effective
international control, the affirmation of the principles of justice, equality and mutual benefit in relations
among countries and the realization of the right of peoples under alien and colonial domination and
foreign occupation to self-determination and independence, as well as respect for national sovereignty
and territorial integrity, will promote social progress and development and as a consequence will
contribute to the attainment of full equality between men and women,
Convinced that the full and complete development of a country, the welfare of the world and the cause
of peace require the maximum participation of women on equal terms with men in all fields,
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107
Bearing in mind the great contribution of women to the welfare of the family and to the development
of society, so far not fully recognized, the social significance of maternity and the role of both parents
in the family and in the upbringing of children, and aware that the role of women in procreation should
not be a basis for discrimination but that the upbringing of children requires a sharing of responsibility
between men and women and society as a whole,
Aware that a change in the traditional role of men as well as the role of women in society and in the
family is needed to achieve full equality between men and women,
Determined to implement the principles set forth in the Declaration on the Elimination of
Discrimination against Women and, for that purpose, to adopt the measures required for the
elimination of such discrimination in all its forms and manifestations,
Have agreed on the following:
PART I
Article 1
For the purposes of the present Convention, the term "discrimination against women" shall mean any
distinction, exclusion or restriction made on the basis of sex which has the effect or purpose of
impairing or nullifying the recognition, enjoyment or exercise by women, irrespective of their marital
status, on a basis of equality of men and women, of human rights and fundamental freedoms in the
political, economic, social, cultural, civil or any other field.
Article 2
States Parties condemn discrimination against women in all its forms, agree to pursue by all
appropriate means and without delay a policy of eliminating discrimination against women and, to this
end, undertake:
(a) To embody the principle of the equality of men and women in their national constitutions or other
appropriate legislation if not yet incorporated therein and to ensure, through law and other appropriate
means, the practical realization of this principle;
(b) To adopt appropriate legislative and other measures, including sanctions where appropriate,
prohibiting all discrimination against women; (c) To establish legal protection of the rights of women
on an equal basis with men and to ensure through competent national tribunals and other public
institutions the effective protection of women against any act of discrimination;
(d) To refrain from engaging in any act or practice of discrimination against women and to ensure that
public authorities and institutions shall act in conformity with this obligation;
(e) To take all appropriate measures to eliminate discrimination against women by any person,
organization or enterprise;
(f) To take all appropriate measures, including legislation, to modify or abolish existing laws,
regulations, customs and practices which constitute discrimination against women;
(g) To repeal all national penal provisions which constitute discrimination against women.
Article 3
States Parties shall take in all fields, in particular in the political, social, economic and cultural fields, all
appropriate measures, including legislation, to en sure the full development and advancement of
women , for the purpose of guaranteeing them the exercise and enjoyment of human rights and
fundamental freedoms on a basis of equality with men.
Article 4
3
108
1. Adoption by States Parties of temporary special measures aimed at accelerating de facto equality
between men and women shall not be considered discrimination as defined in the present Convention,
but shall in no way entail as a consequence the maintenance of unequal or separate standards; these
measures shall be discontinued when the objectives of equality of opportunity and treatment have
been achieved.
2. Adoption by States Parties of special measures, including those measures contained in the present
Convention, aimed at protecting maternity shall not be considered discriminatory.
Article 5
States Parties shall take all appropriate measures:
(a) To modify the social and cultural patterns of conduct of men and women, with a view to achieving
the elimination of prejudices and customary and all other practices which are based on the idea of the
inferiority or the superiority of either of the sexes or on stereotyped roles for men and women;
(b) To ensure that family education includes a proper understanding of maternity as a social function
and the recognition of the common responsibility of men and women in the upbringing and
development of their children, it being understood that the interest of the children is the primordial
consideration in all cases.
Article 6
States Parties shall take all appropriate measures, including legislation, to suppress all forms of traffic
in women and exploitation of prostitution of women.
PART II
Article 7
States Parties shall take all appropriate measures to eliminate discrimination against women in the
political and public life of the country and, in particular, shall ensure to women, on equal terms with
men, the right:
(a) To vote in all elections and public referenda and to be eligible for election to all publicly elected
bodies;
(b) To participate in the formulation of government policy and the implementation thereof and to hold
public office and perform all public functions at all levels of government;
(c) To participate in non-governmental organizations and associations concerned with the public and
political life of the country.
Article 8
States Parties shall take all appropriate measures to ensure to women, on equal terms with men and
without any discrimination, the opportunity to represent their Governments at the international level
and to participate in the work of international organizations.
Article 9
1. States Parties shall grant women equal rights with men to acquire, change or retain their
nationality. They shall ensure in particular that neither marriage to an alien nor change of nationality
by the husband during marriage shall automatically change the nationality of the wife, render her
stateless or force upon her the nationality of the husband. 2. States Parties shall grant women equal
rights with men with respect to the nationality of their children.
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109
PART III
Article 10
States Parties shall take all appropriate measures to eliminate discrimination against women in order
to ensure to them equal rights with men in the field of education and in particular to ensure, on a basis
of equality of men and women:
(a) The same conditions for career and vocational guidance, for access to studies and for the
achievement of diplomas in educational establishments of all categories in rural as well as in urban
areas; this equality shall be ensured in pre-school, general, technical, professional and higher technical
education, as well as in all types of vocational training;
(b) Access to the same curricula, the same examinations, teaching staff with qualifications of the same
standard and school premises and equipment of the same quality;
(c) The elimination of any stereotyped concept of the roles of men and women at all levels and in all
forms of education by encouraging coeducation and other types of education which will help to achieve
this aim and, in particular, by the revision of textbooks and school programmes and the adaptation of
teaching methods;
(d ) The same opportunities to benefit from scholarships and other study grants;
(e) The same opportunities for access to programmes of continuing education, including adult and
functional literacy programmes, particulary those aimed at reducing, at the earliest possible time, any
gap in education existing between men and women;
(f) The reduction of female student drop-out rates and the organization of programmes for girls and
women who have left school prematurely;
(g) The same Opportunities to participate actively in sports and physical education;
(h) Access to specific educational information to help to ensure the health and well-being of families,
including information and advice on family planning.
Article 11
1. States Parties shall take all appropriate measures to eliminate discrimination against women in the
field of employment in order to ensure, on a basis of equality of men and women, the same rights, in
particular:
(a) The right to work as an inalienable right of all human beings;
(b) The right to the same employment opportunities, including the application of the same criteria for
selection in matters of employment;
(c) The right to free choice of profession and employment, the right to promotion, job security and all
benefits and conditions of service and the right to receive vocational training and retraining, including
apprenticeships, advanced vocational training and recurrent training;
(d) The right to equal remuneration, including benefits, and to equal treatment in respect of work of
equal value, as well as equality of treatment in the evaluation of the quality of work;
(e) The right to social security, particularly in cases of retirement, unemployment, sickness, invalidity
and old age and other incapacity to work, as well as the right to paid leave;
(f) The right to protection of health and to safety in working conditions, including the safeguarding of
the function of reproduction.
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110
2. In order to prevent discrimination against women on the grounds of marriage or maternity and to
ensure their effective right to work, States Parties shall take appropriate measures:
(a) To prohibit, subject to the imposition of sanctions, dismissal on the grounds of pregnancy or of
maternity leave and discrimination in dismissals on the basis of marital status;
(b) To introduce maternity leave with pay or with comparable social benefits without loss of former
employment, seniority or social allowances;
(c) To encourage the provision of the necessary supporting social services to enable parents to
combine family obligations with work responsibilities and participation in public life, in particular
through promoting the establishment and development of a network of child-care facilities;
(d) To provide special protection to women during pregnancy in types of work proved to be harmful to
them.
3. Protective legislation relating to matters covered in this article shall be reviewed periodically in the
light of scientific and technological knowledge and shall be revised, repealed or extended as necessary.
Article 12
1. States Parties shall take all appropriate measures to eliminate discrimination against women in the
field of health care in order to ensure, on a basis of equality of men and women, access to health care
services, including those related to family planning.
2. Notwithstanding the provisions of paragraph I of this article, States Parties shall ensure to women
appropriate services in connection with pregnancy, confinement and the post-natal period, granting
free services where necessary, as well as adequate nutrition during pregnancy and lactation.
Article 13
States Parties shall take all appropriate measures to eliminate discrimination against women in other
areas of economic and social life in order to ensure, on a basis of equality of men and women, the
same rights, in particular:
(a) The right to family benefits;
(b) The right to bank loans, mortgages and other forms of financial credit;
(c) The right to participate in recreational activities, sports and all aspects of cultural life.
Article 14
1. States Parties shall take into account the particular problems faced by rural women and the
significant roles which rural women play in the economic survival of their families, including their work
in the non-monetized sectors of the economy, and shall take all appropriate measures to ensure the
application of the provisions of the present Convention to women in rural areas.
2. States Parties shall take all appropriate measures to eliminate discrimination against women in rural
areas in order to ensure, on a basis of equality of men and women, that they participate in and benefit
from rural development and, in particular, shall ensure to such women the right:
(a) To participate in the elaboration and implementation of development planning at all levels;
(b) To have access to adequate health care facilities, including information, counselling and services in
family planning;
(c) To benefit directly from social security programmes;

6
111
(d) To obtain all types of training and education, formal and non-formal, including that relating to
functional literacy, as well as, inter alia, the benefit of all community and extension services, in order
to increase their technical proficiency;
(e) To organize self-help groups and co-operatives in order to obtain equal access to economic
opportunities through employment or self employment;
(f) To participate in all community activities;
(g) To have access to agricultural credit and loans, marketing facilities, appropriate technology and
equal treatment in land and agrarian reform as well as in land resettlement schemes;
(h) To enjoy adequate living conditions, particularly in relation to housing, sanitation, electricity and
water supply, transport and communications.
PART IV
Article 15
1. States Parties shall accord to women equality with men before the law.
2. States Parties shall accord to women, in civil matters, a legal capacity identical to that of men and
the same opportunities to exercise that capacity. In particular, they shall give women equal rights to
conclude contracts and to administer property and shall treat them equally in all stages of procedure in
courts and tribunals.
3. States Parties agree that all contracts and all other private instruments of any kind with a legal
effect which is directed at restricting the legal capacity of women shall be deemed null and void.
4. States Parties shall accord to men and women the same rights with regard to the law relating to the
movement of persons and the freedom to choose their residence and domicile.
Article 16
1. States Parties shall take all appropriate measures to eliminate discrimination against women in all
matters relating to marriage and family relations and in particular shall ensure, on a basis of equality
of men and women:
(a) The same right to enter into marriage;
(b) The same right freely to choose a spouse and to enter into marriage only with their free and full
consent;
(c) The same rights and responsibilities during marriage and at its dissolution;
(d) The same rights and responsibilities as parents, irrespective of their marital status, in matters
relating to their children; in all cases the interests of the children shall be paramount;
(e) The same rights to decide freely and responsibly on the number and spacing of their children and
to have access to the information, education and means to enable them to exercise these rights;
(f) The same rights and responsibilities with regard to guardianship, wardship, trusteeship and
adoption of children, or similar institutions where these concepts exist in national legislation; in all
cases the interests of the children shall be paramount;
(g) The same personal rights as husband and wife, including the right to choose a family name, a
profession and an occupation;
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112
(h) The same rights for both spouses in respect of the ownership, acquisition, management,
administration, enjoyment and disposition of property, whether free of charge or for a valuable
consideration.
2. The betrothal and the marriage of a child shall have no legal effect, and all necessary action,
including legislation, shall be taken to specify a minimum age for marriage and to make the
registration of marriages in an official registry compulsory.
PART V
Article 17
1. For the purpose of considering the progress made in the implementation of the present Convention,
there shall be established a Committee on the Elimination of Discrimination against Women
(hereinafter referred to as the Committee) consisting, at the time of entry into force of the Convention,
of eighteen and, after ratification of or accession to the Convention by the thirty-fifth State Party, of
twenty-three experts of high moral standing and competence in the field covered by the Convention.
The experts shall be elected by States Parties from among their nationals and shall serve in their
personal capacity, consideration being given to equitable geographical distribution and to the
representation of the different forms of civilization as well as the principal legal systems.
2. The members of the Committee shall be elected by secret ballot from a list of persons nominated by
States Parties. Each State Party may nominate one person from among its own nationals.
3. The initial election shall be held six months after the date of the entry into force of the present
Convention. At least three months before the date of each election the Secretary-General of the United
Nations shall address a letter to the States Parties inviting them to submit their nominations within two
months. The Secretary-General shall prepare a list in alphabetical order of all persons thus nominated,
indicating the States Parties which have nominated them, and shall submit it to the States Parties.
4. Elections of the members of the Committee shall be held at a meeting of States Parties convened by
the Secretary-General at United Nations Headquarters. At that meeting, for which two thirds of the
States Parties shall constitute a quorum, the persons elected to the Committee shall be those
nominees who obtain the largest number of votes and an absolute majority of the votes of the
representatives of States Parties present and voting.
5. The members of the Committee shall be elected for a term of four years. However, the terms of
nine of the members elected at the first election shall expire at the end of two years; immediately after
the first election the names of these nine members shall be chosen by lot by the Chairman of the
Committee.
6. The election of the five additional members of the Committee shall be held in accordance with the
provisions of paragraphs 2, 3 and 4 of this article, following the thirty-fifth ratification or accession.
The terms of two of the additional members elected on this occasion shall expire at the end of two
years, the names of these two members having been chosen by lot by the Chairman of the Committee.
7. For the filling of casual vacancies, the State Party whose expert has ceased to function as a member
of the Committee shall appoint another expert from among its nationals, subject to the approval of the
Committee.
8. The members of the Committee shall, with the approval of the General Assembly, receive
emoluments from United Nations resources on such terms and conditions as the Assembly may decide,
having regard to the importance of the Committee's responsibilities.
9. The Secretary-General of the United Nations shall provide the necessary staff and facilities for the
effective performance of the functions of the Committee under the present Convention.
8
113
Article 18
1. States Parties undertake to submit to the Secretary-General of the United Nations, for consideration
by the Committee, a report on the legislative, judicial, administrative or other measures which they
have adopted to give effect to the provisions of the present Convention and on the progress made in
this respect:
(a) Within one year after the entry into force for the State concerned;
(b) Thereafter at least every four years and further whenever the Committee so requests.
2. Reports may indicate factors and difficulties affecting the degree of fulfilment of obligations under
the present Convention.
Article 19
1. The Committee shall adopt its own rules of procedure. 2. The Committee shall elect its officers for a
term of two years.
Article 20
1. The Committee shall normally meet for a period of not more than two weeks annually in order to
consider the reports submitted in accordance with article 18 of the present Convention.
2. The meetings of the Committee shall normally be held at United Nations Headquarters or at any
other convenient place as determined by the Committee.
Article 21
1. The Committee shall, through the Economic and Social Council, report annually to the General
Assembly of the United Nations on its activities and may make suggestions and general
recommendations based on the examination of reports and information received from the States
Parties. Such suggestions and general recommendations shall be included in the report of the
Committee together with comments, if any, from States Parties.
2. The Secretary-General of the United Nations shall transmit the reports of the Committee to the
Commission on the Status of Women for its information.
Article 22
The specialized agencies shall be entitled to be represented at the consideration of the implementation
of such provisions of the present Convention as fall within the scope of their activities. The Committee
may invite the specialized agencies to submit reports on the implementation of the Convention in areas
falling within the scope of their activities.
PART VI
Article 23
Nothing in the present Convention shall affect any provisions that are more conducive to the
achievement of equality between men and women which may be contained:
(a) In the legislation of a State Party; or
(b) In any other international convention, treaty or agreement in force for that State.
Article 24
9
114
States Parties undertake to adopt all necessary measures at the national level aimed at achieving the
full realization of the rights recognized in the present Convention.
Article 25
1. The present Convention shall be open for signature by all States.
2. The Secretary-General of the United Nations is designated as the depositary of the present
Convention.
3. The present Convention is subject to ratification. Instruments of ratification shall be deposited with
the Secretary-General of the United Nations.
4. The present Convention shall be open to accession by all States. Accession shall be effected by the
deposit of an instrument of accession with the Secretary-General of the United Nations.
Article 26
1. A request for the revision of the present Convention may be made at any time by any State Party by
means of a notification in writing addressed to the Secretary-General of the United Nations.
2. The General Assembly of the United Nations shall decide upon the steps, if any, to be taken in
respect of such a request.
Article 27
1. The present Convention shall enter into force on the thirtieth day after the date of deposit with the
Secretary-General of the United Nations of the twentieth instrument of ratification or accession.
2. For each State ratifying the present Convention or acceding to it after the deposit of the twentieth
instrument of ratification or accession, the Convention shall enter into force on the thirtieth day after
the date of the deposit of its own instrument of ratification or accession.
Article 28
1. The Secretary-General of the United Nations shall receive and circulate to all States the text of
reservations made by States at the time of ratification or accession.
2. A reservation incompatible with the object and purpose of the present Convention shall not be
permitted.
3. Reservations may be withdrawn at any time by notification to this effect addressed to the Secretary-
General of the United Nations, who shall then inform all States thereof. Such notification shall take
effect on the date on which it is received.
Article 29
1. Any dispute between two or more States Parties concerning the interpretation or application of the
present Convention which is not settled by negotiation shall, at the request of one of them, be
submitted to arbitration. If within six months from the date of the request for arbitration the parties
are unable to agree on the organization of the arbitration, any one of those parties may refer the
dispute to the International Court of Justice by request in conformity with the Statute of the Court.
2. Each State Party may at the time of signature or ratification of the present Convention or accession
thereto declare that it does not consider itself bound by paragraph I of this article. The other States
Parties shall not be bound by that paragraph with respect to any State Party which has made such a
reservation.
10
115
3. Any State Party which has made a reservation in accordance with paragraph 2 of this article may at
any time withdraw that reservation by notification to the Secretary-General of the United Nations.
Article 30
The present Convention, the Arabic, Chinese, English, French, Russian and Spanish texts of which are
equally authentic, shall be deposited with the Secretary-General of the United Nations. IN WITNESS
WHEREOF the undersigned, duly authorized, have signed the present Convention.
//true copy//
Annexure P/2 116
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ESHRE PAGES
Survey on ART and IUI: legislation,

regulation, funding and registries in
European countries
The European IVF-monitoring Consortium (EIM) for the
European Society of Human Reproduction and
Embryology (ESHRE)
C. Calhaz-Jorge 1,2,*, Ch De Geyter3 , M.S. Kupka4 , C. Wyns5 ,
E. Mocanu6 , T. Motrenko7 , G. Scaravelli8 , J. Smeenk9 , S. Vidakovic10 ,
and V. Goossens 2
1
Faculdade de Medicina, Universidade de Lisboa, Lisbon, Portugal 2 ESHRE Central Office, Belgium 3 Institute of Reproductive Medicine
and Gynecological Endocrinology (RME), Basel, Switzerland 4 Center for Reproductive Medicine, Gynaekologicum Hamburg, Hamburg,
Germany 5 Cliniques Universitaires Saint Luc, Université Catholique de Louvain, Brussels, Belgium 6 Rotunda Hospital and Royal College of
Surgeons in Ireland, Dublin, Ireland 7 Human Reproduction Center Budva, Budva, Montenegro 8 Registro Nazionale della Procreazione
Medicalmente Assistita, Istituto Superiore di Sanità, Roma, Italy 9 Department of Obstetrics and Gynaecology, Elisabeth Twee Steden
Hospital, Tilburg, The Netherlands 10 Clinical Center Serbia, “GAK” Institute for Obstetrics and Gynecology, Belgrade, Serbia
*Correspondence address. Faculdade de Medicina da Universidade de Lisboa, Avenida Professor Egas Moniz, 1649-028 Lisboa, Portugal.
Tel: +351217805180; E-mail: [email protected] https://orcid.org/0000-0003-2941-113X
Submitted on October 14, 2019; resubmitted on October 14, 2019; editorial decision on November 9, 2019
STUDY QUESTION: How are ART and IUI regulated, funded and registered in European countries?
SUMMARY ANSWER: Of the 43 countries performing ART and IUI in Europe, and participating in the survey, specific legislation exists in
only 39 countries, public funding (also available in the 39 countries) varies across and sometimes within countries and national registries are in
place in 31 countries.
WHAT IS KNOWN ALREADY: Some information devoted to particular aspects of accessibility to ART and IUI is available, but most is
fragmentary or out-dated. Annual reports from the European IVF-Monitoring (EIM) Consortium for ESHRE clearly mirror different approaches
in European countries regarding accessibility to and efficacy of those techniques.
STUDY DESIGN, SIZE, DURATION: A survey was designed using the online SurveyMonkey tool consisting of 55 questions concerning
three domains—legal, funding and registry. Answers refer to the countries’ situation on 31 December 2018.
PARTICIPANTS/MATERIALS, SETTINGS, METHODS: All members of EIM plus representatives of countries not yet members of the
Consortium were invited to participate. Answers received were checked, and initial responders were asked to address unclear answers and
to provide any additional information they considered important. Tables of individual countries resulting from the consolidated data were then
sent to members of the Committee of National Representatives of ESHRE, asking for a second check. Conflicting information was clarified by
direct contact.
MAIN RESULTS AND THE ROLE OF CHANCE: Information was received from 43 out of the 44 European countries where ART and
IUI are performed. Thirty-nine countries reported specific legislation on ART, and artificial insemination was considered an ART technique in
35 of them. Accessibility is limited to infertile couples in 11 of the 43 countries. A total of 30 countries offer treatments to single women and
18 to female couples. In five countries ART and IUI are permitted for treatment of all patient groups, being infertile couples, single women
and same sex couples, male and female. Use of donated sperm is allowed in 41 countries, egg donation in 38, the simultaneous donation of
sperm and egg in 32 and embryo donation in 29. Preimplantation genetic testing (PGT) for monogenic disorders or structural rearrangements
is not allowed in two countries, and PGT for aneuploidy is not allowed in 11; surrogacy is accepted in 16 countries. With the exception of
marital/sexual situation, female age is the most frequently reported limiting criteria for legal access to ART—minimal age is usually set at
.
© The Author(s) 2020. Published by Oxford University Press on behalf of the European Society . of Human Reproduction and Embryology.
.
. Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/), which per-
This is an Open Access article distributed under the terms of the Creative Commons Attribution
.
mits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact [email protected]
2 Calhaz-Jorge et al.118
18 years and maximum ranging from 45 to 51 years with some countries not using numeric definition. Male maximum age is set in very few
countries. Where permitted, age is frequently a limiting criterion for third-party donors (male maximum age 35 to 55 years; female maximum
age 34 to 38 years). Other legal constraints in third-party donation are the number of children born from the same donor (in some countries,
number of families with children from the same donor) and, in 10 countries, a maximum number of egg donations. How countries deal with the
anonymity is diverse—strict anonymity, anonymity just for the recipients (not for children when reaching legal adulthood age), mixed system
(anonymous and non-anonymous donations) and strict non-anonymity.
Public funding systems are extremely variable. Four countries provide no financial assistance to patients. Limits to the provision of funding
are defined in all the others i.e. age (female maximum age is the most used), existence of previous children, maximum number of treatments
publicly supported and techniques not entitled for funding. In a few countries, reimbursement is linked to a clinical policy. The definition of the
type of expenses covered within an IVF/ICSI cycle, up to what limit and the proportion of out-of-pocket costs for patients is also extremely
dissimilar.
National registries of ART and IUI are in place in 31 out of the 43 countries contributing to the survey, and a registry of donors exists in 18 of
them.
LIMITATIONS, REASONS FOR CAUTION: The responses were provided by well-informed and committed individuals and submitted to
double checking. Since no formal validation was in place, possible inaccuracies cannot be excluded. Also, results are a cross section in time and
ART and IUI legislations within European countries undergo continuous evolution. Finally, several domains of ART activity were deliberately
left out of the scope of this ESHRE survey.
WIDER IMPLICATIONS OF THE FINDINGS: Results of this survey offer a detailed view of the ART and IUI situation in European
countries. It provides updated and extensive answers to many relevant questions related to ART usage at national level and could be used by
institutions and policymakers in planning services at both national and European levels.
STUDY FUNDING/COMPETING INTEREST(S): The study has no external funding, and all costs were covered by ESHRE. There were
no competing interests.
ESHRE Pages are not externally peer reviewed. This article has been approved by the Executive Committee of ESHRE.
Key words: ART / IVF / ICSI / IUI / gamete donation / embryo donation / surrogacy / legislation / public funding / European
registries
.
Introduction .
.
and IUI activity have been published that mirror the huge diversity
. of the use of these therapeutic techniques in Europe. In spite of the
.
IVF started more than 40 years ago, and it is estimated that more . well-accomplished International Federation of Fertility Societies (IFFS)
.
than 8 million human beings resulted from ART techniques so far. . Surveillance that was made public some years ago (IFFS, 2016), a
.
It started as a therapeutic treatment for infertile couples with irre- . detailed survey was organized under the umbrella of the EIM with the
.
.
versible tubal factor and expanded to infertility situations caused by . aim to fill the relevant recognized gaps and update the information on
.
other factors (and even to unexplained infertility) and to cases of . these topics.
.
impairment of a person’s capacity to reproduce (single women, same . The present paper provides a global picture of the legislation, regu-
.
sex couples). Owing to many political, social and sensitive ethical . lations, public funding and registry systems on ART and IUI in Europe
.
issues related to ART and IUI practice, it is not unexpected that .
. on 31 December 2018.
.
different societies have adhered to these techniques from many diverse .
.
perspectives. .
Many factors have been studied and accepted as contributing to
.
. Materials and Methods
.
those very important differences among countries. Some are related . Relevant questions were defined by the Steering Committee of EIM. A
.
.
to financial issues, for example affordability, treatment costs and out- . survey was then designed using the online SurveyMonkey tool including
.
of-pocket payment by users. Others refer to cultural and belief dimen- . a total of 55 questions divided into three domains—legal frame, funding
.
sions (i.e. level of acceptance by the society, customary law and . frame and registry. All members of EIM (plus representatives of coun-
.
religious pattern of the community). Finally, individual decisions and . tries not yet members of the Consortium) were invited to participate.
.
professional options (postponement of reproductive desire, fertility .
. The survey was performed in two steps, ending with referring to the
.
preservation) are not equally valued in every society. Several publica- . countries’ situation on 31 December 2018.
.
tions have already approached many of the issues in this complex field . Answers were transposed to an Excel file and checked. Initial respon-
.
(Adamson, 2009; Balbo et al., 2013; Präg and Mills, 2017). . ders were asked to clarify doubtful points and to provide any additional
.
In 1999, the European IVF Monitoring (EIM) Consortium was estab- . information they considered important. Tables of individual countries
.
.
lished by ESHRE with the mission to organize an IVF data collection . resulting from the consolidated data were sent to members of the
.
programme for Europe. In 2002, IUI data started to be collected as . Committee of National Representatives (CNR) of ESHRE, asking for
.
well. Over the years, the Consortium included representatives of an . a second check. The rationale was to do external auditing since, with
.
increasing number of European countries, reaching a total of 43 at . a few exceptions, members of the CNR are not members of EIM.
.
present (De Geyter et al., 2018). So far, 18 annual reports on ART .
. Conflicting information was clarified by direct contact.
ART and IUI regulation, funds and registers in Europe, 2018 119
3
.
Results . also a legal limit in 18 countries, ranging from 45 years in Denmark
.
. and Belgium (in the latter, this limit applies to oocyte retrievals while
Information was received from 43 out of the 44 European countries .
. embryo replacement and insemination are allowed up to 47 years)
in which ART and IUI is performed (Azerbaijan missing). Bosnia and .
. to 51 in Bulgaria. In Austria, ‘natural cycle available’ is an undefined
.
Herzegovina consist of two individual political entities—Federation . criterion for a maximum age. Male maximum age is legally set in
.
of Bosnia and Herzegovina, and Republika Srpska. Their answers are .
. Portugal (60 years) and is recommended in Finland (60 years) and
presented separately when appropriate. Occasionally countries could .
. Sweden (56 years). According to Swiss regulations, ‘the potential father
not provide complete responses to all queries. .
. should be able to be alive until the child is 18 years-old’. A particular
.
. case is France where no definition of numerical age limits exists, and it
.
Legal framework . is the responsibility of the centres to define in practice the legal concept
.
Most countries referred to having specific legislation on ART. Excep- . of ‘normal reproductive age’. Other potential legal/regulatory limi-
.
.
tions were Albania, Bosnia and Herzegovina (Federation), Ireland, . tations were explored—maximum BMI, female active smoking, male
.
Romania and Ukraine. . active smoking and previous children of the couple/woman. None of
.
Accessibility is legally restricted to heterosexual couples in 11 coun- . these potential legal/regulatory limitations was reported to be a legal
.
tries—Albania, Bosnia and Herzegovina, Czech Republic, France, Italy, . constraint for access to ART. In Lithuania, ART is not permitted if the
.
Lithuania, Poland, Slovakia, Slovenia, Switzerland and Turkey. In five, . patients have medical contraindications listed in the specific ART law.
.
ART and IUI techniques are also permitted for single women and . In Germany, ART is not reimbursed for individuals after sterilisation,
.
.
same sex couples. Most countries are somewhere between these two . such as vasectomy and tubal ligation.
.
extremes with a total of 30 offering treatments to single women and .
.
18 to female couples. . Legal limits in third-party donations
.
Use of donated sperm in ART and IUI is allowed in the majority . Sperm donation is limited to men over 18 years in 16 out of the
.
of countries except Bosnia and Herzegovina and Turkey. However, .
. 41 countries where the donation is permitted (Table III). No minimal
participants from Croatia and Montenegro stated that no local donors .
. age is defined in other countries where the procedure is allowed. A
.
are available in their countries and in Croatia sperm may be imported . maximum male age for donors is established in 21 countries, ranging
.
from abroad. Egg donation is not permitted in Bosnia and Herzegovina, . from 35 years old in Hungary, Kazakhstan, Russia and Slovakia to
.
Germany, Norway, Switzerland and Turkey. Although accepted in . 55 years old in Slovenia. The most common maximum age is 40 years
.
Croatia, Ireland, Italy and Montenegro, no local donations are per- . old. Some limitations in the number of infants originating from the
.
formed. The simultaneous donation of sperm and egg is not permitted .
. same donor are in place in 30 countries, although in five of them
in the countries where egg donation is forbidden and also in Armenia, .
. it is just a recommendation and not a legal obligation. This number
.
Croatia, France, Montenegro, Slovenia and Sweden. Embryo donation . ranges from 1 in Cyprus to 25 in The Netherlands. In 7 out of the
.
is not allowed in 14 countries (Austria, Armenia, Belarus, Bosnia and . 30 countries (Belgium, Denmark, Finland, Portugal, Slovenia, Sweden
.
Herzegovina, Bulgaria, Denmark, Iceland, Italy, Kazakhstan, Norway, . and UK), there is a maximal number of families/women that may have
.
Slovenia, Sweden, Switzerland and Turkey). Information on individual .
. children resulting from the same donor (ranging from two for Slovenia
countries is shown in Table I. .
. to 12 for Denmark).
.
Countries also differ with regards to some particular techniques . Egg donors must be over 18 years old in 15 out of the 36 countries
.
(Supplementary Table SI). It is the case for preimplantation genetic . where the donation is performed. A maximum age for donors is
.
testing (PGT) for monogenic disorders/chromosome structural rear- . established in 25 countries, ranging from 34 years in Serbia to 38 years
.
rangements (PGT-M/SR; formerly PGD), which is allowed in all coun- . in France, with the vast majority of countries setting the limit at
.
tries except Bosnia and Herzegovina and Malta. PGT for aneuploidies .
. 35 years. Bulgaria and Denmark are less restrictive about the donor’s
(PGT-A; formerly preimplantation genetic screening) is not permit- .
. maximum age if the donors/relatives are known to one another. In
.
ted in Bosnia and Herzegovina and Malta, as well as in Denmark, . Belarus, Bulgaria, Hungary and Ukraine, egg donors must have at least
.
France, Germany, Hungary, Lithuania, Norway, Slovenia, Sweden and . one child. This condition is considered desirable but not mandatory in
.
The Netherlands. Surrogacy is allowed in Albania, Armenia, Belarus, . the selection of egg donors in Romania and Sweden. The maximum
.
Belgium, Cyprus, Czech Republic, Georgia, Greece, Kazakhstan, Mace- . number of donations is specified in 10 countries—from one (two in
.
donia, Romania, Russia, The Netherlands, UK and Ukraine. .
. rare exceptions) in Slovenia to 20 in Belarus; most common numbers
Embryo sex selection (outside PGT-M for sex-linked diseases) is not .
. are between four and six. A maximum number of infants originating
.
allowed in any of the 43 countries. . from the same donor is defined in 25 countries, although in 3 of them it
.
IUI is considered an ART technique under the national legislation of . is just a recommendation and not a legal requirement. This value ranges
.
35 countries. Additional information will be presented in an individual . from 2 in Montenegro to 10 in France, Greece, Kazakhstan and Italy. In
.
subsection. .
. 6 out of the 25 countries (Belgium, Finland, Serbia, Slovenia, Sweden
.
. and UK), there is a maximal number of families/women that may have
Legal limits for ART access .
. children resulting from the same egg donor (ranging from one for Serbia
.
Marital status and sexual orientation are often seen as limitations for . to 10 for UK).
.
ART. However, 34 out of the 43 countries have also legal age limits .
.
for candidates to ART (Table II). In 21, males and females must be . The anonymity issue
.
above 18 years. Belgium, Kazakhstan and Malta define a minimal female . The issue of anonymity is addressed in very diverse ways across Europe
.
age but have no such limitation for males. Maximum female age is . (Supplementary Table SII). As regards gamete donation, four different
.
120
4
Table I Legislation on ART in European countries—third-party donation.
Countries Is Who can have access to IVF/ICSI

there a ..........................................................................................................................................................................................................
specific with donated sperm? with donated eggs? with donated sperm plus donated with donated embryos
ART eggs?
law? ................................................. ................................................. ................................................. .................................................
Hetero- Female Single Male Hetero- Female Single Male Hetero- Female Single Male Hetero- Female Single Male
sexual couples women couples sexual couples women couples sexual couples women couples sexual couples women couples
couples couples couples couples
.................................................................................................................................................................................................................................................
Albania No x x x x
Austria Yes x x x x x x
Armenia Yes x x x
Belarus Yes x x x x x x
Belgium Yes x x x x x x x x x x x x x x x x
∗∗ Bosnia
and No
Herzegovina – Fed
Bosnia and Yes
Herzegovina – Rep
Bulgaria Yes x x x x x x x x x
Croatia Yes x x x x x
Cyprus Yes x x x x x x x x
Czech Republic Yes x x x x
Denmark Yes x x x x x x x x x
Estonia Yes x x x x x x x x x x x x
Finland Yes x x x x x x x x x x x x
France Yes x x x
Georgia Yes x x x x x x x x
Germany Yes x x∗ x∗ x
Greece Yes x x x x x x x x
Hungary Yes x x x x x x x
Iceland Yes x x x x x x x x x
Ireland No x x x x x x x x x x x x
Italy Yes x x x
Kazakhstan Yes x x x x x x
Latvia Yes x x x x x x x x x x x
Lithuania Yes x x x x
Calhaz-Jorge et al.
Macedonia Yes x x x x x x x x
Malta Yes x x x x x x x x x x x x x x x x
Moldova Yes x x x x x x x
(Continued)
121
ART and IUI regulation, funds and registers in Europe, 2018

Table I Continued
Countries Is Who can have access to IVF/ICSI

there a ..........................................................................................................................................................................................................
specific with donated sperm? with donated eggs? with donated sperm plus donated with donated embryos
ART eggs?
law? ................................................. ................................................. ................................................. .................................................
Hetero- Female Single Male Hetero- Female Single Male Hetero- Female Single Male Hetero- Female Single Male
sexual couples women couples sexual couples women couples sexual couples women couples sexual couples women couples
couples couples couples couples
.................................................................................................................................................................................................................................................
Montenegro Yes x x x x
Norway Yes x x
Poland Yes x x x x
Portugal Yes x x x x x x x x x x x x
Republic of Serbia Yes x x x x x
Romania No x x x x x x x x x x x x
Russia Yes x x x x x x x x
Slovakia Yes x x x x
Slovenia Yes x x
Spain Yes x x x x x x x x x x x x
Sweden Yes x x x x
Switzerland Yes x
The Netherlands Yes x x x x x x x x x x x x x x x x
Turkey Yes
UK Yes x x x x x x x x x x x x x x x x
Ukraine No x x x x x x x x
∗ Not possible in some areas

∗∗ Bosnia and Herzegovina consist of two individual political entities – Federation of Bosnia and Herzegovina (Fed) and Republika Srpska (Rep).
5
6 Calhaz-Jorge et al. 122
Table II Legal limits for ART access.
Countries Are there legal .............................................................

Female Male
.............................................................
limits?
Minimal age (years) Maximum age (years) Minimal age (years) Maximum age (years)
.........................................................................................................................................................................................
Albania x No 50 No No
Austria x 18 Natural cycle available 18 No
Armenia No
Belarus x 18 50 18 No
Belgium x 18 45 y for oocyte retrieval; 47 y No No
for embryo transfer
Bosnia and Herzegovina – Fed No
Bosnia and Herzegovina – Rep No
Bulgaria x 18 51 18 No
Croatia x 18 No 18 No
Cyprus x 18 50 18 No
Czech Republic x 18 49 18 No
Denmark x 18 45 18 No
Estonia x 18 50 18 No
Finland x No 40-45 (not in the law but in No 60 (not in the law but in
practice) practice)
France x ‘normal reproductive age’
Georgia Yes
Germany No
Greece x 18 50 18 No
Hungary x 18 49 18 No
Iceland No
Ireland No
Italy x No 46∗∗∗ No No
Kazakhstan x 19 No No No
Latvia x 18 18
Lithuania x 18 No 18 No
Macedonia x No No No No
Malta x 25 48 No No
Moldova No
Montenegro x 18 No 18 No
Norway x No No No No
Poland No
Portugal x 18 50 18 60
Republic of Serbia No
Romania x 18 48 (own eggs); 50 (donated 18 No
eggs)
Russia No
Slovakia x 18 50 18 No
Slovenia x 18 Reproductive age 18 No
Spain x 18 Age of menopause (50 x 2) 18 No
Sweden x 18 No 18 56 (not in the law;
recommendation)
Switzerland x No No No see foot-note∗∗
The Netherlands x No 49 No No
Turkey No
UK x 18 18
Ukraine x 18 No 18 No
∗ ‘normal reproductive age’, decided by the multidisciplinary staff of the centre, with valid consent of both members of the couple
∗∗ The potential father should be able to be alive until the child is 18 years old
∗∗∗ In all regions of the country with one exception where ART is allowed up to 50 years old
123

Table III Legal limits in third-party donation, where permitted.
Countries Age (years) Maximum no. of infants Age (years) Parity of Maximum no. Maximum no. of
........................................ from the same donor ...................................... donors of donations infants from the
Minimal Maximum Minimal Maximum same donor
.................................................................................................................................................................................................................................................
Albania 35
Austria 3 35 3
Armenia Internal protocol: no more than 35 Internal protocol: Internal protocol: 7
7 babies 10
Belarus 18 40 Up to 20 attempts of 18 35 1 child 20
fertilization minimum
Belgium Children in 6 families 18 Children in 6 families
Bulgaria 18 5 18 34 for anonymous; Minimum 1 6 5
37 for relatives born child
Croatia Legally 18 (no donors in practice – imported sperm) Legally 18 (no donors in practice – imported oocytes/going abroad)
Cyprus 45 1 35 1
Czech Republic 18 40 7 (recommended) 18 35 5 (recommended)
Denmark 45 Children in 12 families 35 unless known 6 No
donor
Estonia 40 6 35 6
Finland 18 No law. In practice 40 Same donor can produce 18 No law. Around 35 in Same donor can
children to max 5 women practice produce children to
max 5 women
France 45 10 38 2 10
Georgia No No No No No No
Germany 40 No Egg donation not allowed
Greece 40 10 35 10
Hungary 35 4 35 Donor must 4
have own
child
Iceland
Ireland 10 (embryologist regulated) All abroad
Italy 18 40 10 20 35 10
Kazakhstan 35 10 35 10
Latvia 18 45 3 18 35 3
Lithuania 18 5 18 5
Macedonia 2 2
Malta 18 36 18 36
Moldova 35
(Continued)
7
124
8
Table III Continued.
Countries Age (years) Maximum no. of infants Age (years) Parity of Maximum no. Maximum no. of
........................................ from the same donor ...................................... donors of donations infants from the
Minimal Maximum Minimal Maximum same donor
.................................................................................................................................................................................................................................................
Montenegro No local donors. Sperm imported 3 2
Norway 8 Egg donation not allowed
Poland 10 10
Portugal 18 45 Children in 8 families 18 35 4
Republic of 40 One donor for only one couple, 34 One donor for only
Serbia regardless of children number one couple, regardless
of children number
Romania 18 5 (recommended) 18 (mar- Preferably 2 5 (recommended)
ried) with children (recommended)
Russia 18 35 18 35
Slovakia 35 5 35 5 5
Slovenia 18 55 Children in 2 families 18 35 1 (rare Children in 2 families
exceptions 2)
Spain 18 50 6 18 35 6
Sweden 18 Children in 6 families 18 but we prefer Children in 6 families
that the
woman has
delivered.
Switzerland 8 Egg donation not allowed
The Netherlands not enforced by law, but 25
UK 18 40 Children in 10 families 18 35 Children in 10 families
Ukraine 40 36 At least one 8
healthy child
Iceland provided no information, except that gamete donations are allowed

refers to countries where egg donation is forbidden
Calhaz-Jorge et al.
9
.
scenarios were identified. Strict anonymity is the rule in 18 countries, . receptivity. In this country, surrogacy is also possible for cases of severe
.
although in 5 of these countries disclosure of donors’ identity is . somatic diseases in which pregnancy can endanger the future health or
.
possible in cases of severe health conditions of the child born. A . life of the recipient but does not affect the health of the future child.
.
particular situation is Lithuania where a donor’s identity can be known . Responders from Armenia and Russia reported that in their countries
.
for other (non-specified) important reasons, after a court decision. In . surrogate mothers must be under 35 years of age and have at least one
.
.
some countries (Estonia, Poland and Russia), general information about . healthy child themselves.
.
the donors (nationality, age, weight, height, education) is available .
. The particular situation of transgender
for recipients and children born. In a second group of countries, .
. Gender reassignment is permitted in 27 of the countries that con-
anonymity applies to recipients, but the born children can have access .
.
to donor identity when above a defined age (Austria, Croatia, Finland, . tributed to the survey (Supplementary Table SV). No information has
.
Malta, Portugal, UK). A third scenario is gamete donations under a . been obtained regarding the situation in Cyprus. Cryopreservation of
.
. gametes and/or gonadal tissue prior to reassignment is allowed in 20 of
mixed system (anonymous and non-anonymous) as was described in .
. the responding countries, is not allowed in Greece, Hungary, Slovenia
13 countries. In Bulgaria non-anonymity is exceptional and involves .
. and Turkey and is not regulated in Germany. Information is missing from
donors who are relatives, whereas in Germany and Switzerland the .
.
recipients may bring their own donor who donates just for that couple. . Denmark and Poland.
.
In Belgium, non-anonymous donation is only allowed when there is a . Transgender individuals can have access to ART techniques in
.
formal agreement between the donor and the recipient. In Hungary, . 21 countries. In 19 countries, previously cryopreserved gametes
.
. and/or gonadal tissue can be used. Transgenderism is not regulated in
egg donors must be a relative of the recipient but a sperm donor must .
. Germany.
be anonymous. In Romania, local donations must be non-anonymous .
.
but imported gametes can be from anonymous donors. Finally, non- .
.
anonymity is reported as the rule for gamete donations in Georgia and .
. Public Funding
The Netherlands. .
. The relative importance of public and private ART centres is extremely
.
Embryo donation is permitted in 29 countries under one of three . diverse across countries (Supplementary Table SVI). In Albania, Arme-
.
perspectives: strict anonymity, anonymity except for children born . nia, Georgia, Ireland, Bosnia-Herzegovina, Cyprus and Latvia only pri-
.
and non-anonymity. No country follows a mixed system in embryo . vately owned centres exist, although patients of the last three countries
.
donation. Five out of the 13 countries with a mixed situation for gamete .
. can get public funding for treatments performed in those centres. In
donation allow embryo donation under strict anonymity (Belgium, .
. Belgium, Bulgaria, Czech Republic, Finland, France, Iceland, Moldova,
Germany, Hungary, Ireland and Ukraine). In Romania embryo donation .
. Slovenia, UK and Ukraine, there is no separation between the private
.
is possible only with non-anonymous donors. Embryo donation is not . and public sector and either patients get funding for undergoing ART
.
performed in the seven remaining countries. . in private centres or public centres receive private patients. All the
.
. other countries have distinct publicly funded and completely private
.
Preservation of fertility potential .
. ART centres. The number of ART centres is limited by legislation in
Cryopreservation of gametes for medical conditions that jeopardize .
. France, Norway and The Netherlands.
fertility is allowed in all countries in spite of the absence of specific .
. Albania, Armenia, Georgia and Switzerland allocate no public funds
.
legislation in 17 of them (Supplementary Table SIII). The same is true . for ART patients.
.
for the cryopreservation of gonadal tissue (with the exception of .
.
Bosnia and Herzegovina, where the technique is not performed). .
.
Limits for public funding
Embryo cryopreservation for medical conditions is not permitted in . Access to public funding has some limiting criteria in 29 of the 39 coun-
.
Italy and Portugal, but it is possible only at the two-pronuclear stage in . tries with public financial support to ART (Table IV, Supplementary
.
Germany and is performed in all other countries. Non-medical oocyte . Table SVII). Austria, Belarus, Cyprus, Greece, Kazakhstan, Macedonia,
.
.
freezing is not permitted in Austria, France, Hungary, Lithuania, Malta, . Norway, Russia, Slovakia and Switzerland have no additional limitations
.
Norway, Serbia and Slovenia and is also not performed in Bosnia and . to the legal ones. Maximum female age is a limiting criterion for public
.
Herzegovina and Moldova in spite of the absence of legislation that . funding/reimbursement in 28 out of the 29 countries (the exception is
.
outlaws the technique. . Iceland). It ranges from 38 years in Latvia to 49 years in Czech Republic
.
. with no numeric limit in Finland and diversity across regions of Italy and
.
Surrogacy .
. the UK. Male maximum age is stated in a few countries only—49 years
.
Out of the 15 countries reporting that surrogacy is either allowed . in Germany and Austria, 55 years in Sweden and Spain and 60 years in
.
or performed in the absence of specific legislation, eight detailed . Portugal and Finland (not in law but in practice in the latter).
.
some criteria involved (Supplementary Table SIV). Applications must . Additional relevant limits for public funding relate to the existence
.
be approved by the Competent Authority and a Court in Cyprus, and . of previous children. In Denmark, Malta, Romania and Turkey a couple
.
a favourable Court decision is also required in Greece and Russia. In . (or single women, when applicable) with a child(ren) cannot receive
.
.
Belarus, partners in a couple must provide at least one of the gametes . public assistance for ART and IUI. In Spain and Iceland one child, and in
.
while in The Netherlands the beneficiary may or may not provide . Montenegro two, is the limit. In Portugal and Sweden, only one birth
.
the eggs. Ukraine has the least restrictive criteria as surrogacy can be . of a live child(ren) is reimbursed (although Portuguese patients in that
.
used not only when a uterus is absent or has congenital or surgical . situation can get reimbursement for frozen embryo replacement [FER)
.
deformities but also in the presence of structural–morphological or . of remaining embryos). A maximum female BMI is a limit for receiving
.
anatomic changes in the endometrium leading to so-called loss of . public funding for ART in Romania, Serbia, Spain, Sweden and UK.
.
126
10
Table IV Legal limits for public funding in ART.
Countries Are there Female Male Female BMI Parity

legal limits? ...................................................... ...................................................... kg/m2
Minimum Maximum age Minimum Maximum age
age (years) (years) age (years) (years)
.................................................................................................................................................................................................................................................
Albania No public funding at all
Austria x 39 49
Armenia No public funding at all
Belarus No
Belgium x 42
Bosnia and x No No No No
Herzegovina – Fed
Bosnia and x 42 No
Herzegovina – Rep
Bulgaria x 43 No
Croatia x 42 No
Cyprus No
Czech Republic x 49 No
Denmark x 40 No The couple or single women
cannot have children when
receiving public IVF; a couple
can have children with previous
partner. For IUI there are no
limitations
Estonia x 40 No
Finland x 40-45 (not in law but in 60 (not in law but in practice, in
practice) public centres only)
France x 43 "reproductive age"
Georgia
Germany x 25 39 25 49
Greece No
Hungary x 45 No
Iceland x No No No No 1
Ireland No public funding (except drugs)
Italy x 46 (homologous and donor
cycles)∗
Kazakhstan No
Calhaz-Jorge et al.
Latvia x 38 No
Lithuania x 42 No
(Continued)
127

Table IV Continued
Countries Are there Female Male Female BMI Parity
legal limits? ...................................................... ...................................................... kg/m2
Minimum Maximum age Minimum Maximum age
age (years) (years) age (years) (years)
.................................................................................................................................................................................................................................................
Macedonia No
Malta x 48 No Existence of previous children
of the couple
Moldova x 40 No
Montenegro x 44 No 2
Norway No
Poland x 40 No
Portugal x 40 60 Couples with one child resulting
from ART can only get
reimbursement to FER of
leftover embryos
Republic of Serbia x 42 No 30
Romania x 40 No 30 No living child
Russia No
Slovakia No
Slovenia x 42 No
Spain x 40 55 35 1
Sweden x 39 55 Only for Only one child reimbursed by
public funded public funding, No publicly
IVF funded IVF if children of their
own
Switzerland No
The Netherlands x 42 No
Turkey x 39 No No children
UK x According to NICE guidelines and diverse along the country
Ukraine x 40 No
∗ But there are differences on a regional basis generally lowering the “admission” age to treatments.
FER: frozen embryo replacement, NICE: The National Institute for Health and Care Excellence
11
12 128
Calhaz-Jorge et al.
.
In Belgium, Czech Republic, Slovenia, Sweden and The Netherlands, . publicly funded, and the Czech Republic and Slovakia that ICSI receives
.
public funding is linked to a clinical policy, namely the number of . no public financial support. In Austria, Latvia and Turkey, ‘add-on’ tech-
.
embryos transferred related to female age and the rank of the treat- . niques are out-of-pocket costs. Bosnia and Herzegovina-Federation,
.
ment attempt. With slight differences, elective single embryo transfer . Macedonia and UK stated that not all techniques are funded, but no
.
(eSET) in the first two ART cycles in women up to 35 years (38 years . details were provided.
.
.
in The Netherlands) is the rule. In the Netherlands, there are imposed . ART were considered not to be equally publicly funded across
.
limitations in the use of gonadotrophins. Austria and Malta offer public . the country in Belarus, Bosnia and Herzegovina-Federation, Esto-
.
funding combined with a clinical policy. In Austria, funding is only . nia, Denmark, Germany, Italy, Kazakhstan, Norway, Russia, Spain
.
available in the presence of a medical indication (bilateral tubal defect, . and UK.
.
endometriosis and/or polycystic ovary syndrome and/or male factor .
.
infertility). No details were given for Malta. In UK, the diversity of .
. What is public funding available for?
.
public funding across the country makes it impossible to obtain a clear . Considering the three main areas of expenses in an ART cycle—
.
picture. . medication costs, doctor/medical costs and laboratory costs—
.
To establish contracts with the public funding system, centres must . six different patterns can be identified across Europe: public
.
have a minimum success rate in Austria, Bulgaria, Finland, Romania .
. funding to all three areas of ART performed either in public
and UK. A special case is Hungary where no minimum success rate .
. or in private centres—23 countries; public funding for drugs in
is mandatory, but public centres receive a special amount of money .
. public and private centres, but for doctor/medical and laboratory
.
for each live birth resulting from ART. . costs only in public centres—6 countries; public funding for drugs,
.
The number of cycles publicly funded is quite different from country . doctor/medical and laboratory costs in public centres only—3
.
to country. Three is the most common limit (in 16 countries). In . countries; no reimbursement for medications but public financial
.
the Czech Republic, if the two first attempts end in an eSET, the .
. support for doctor/medical and laboratory supported costs in public
total number of cycles reimbursed increases from three to four. In .
. centres only—2 countries; no reimbursement for medications but
.
Finland, the limit is set case by case—in general three to five. Patients . public financial support for doctor/medical and laboratory costs in
.
in Moldova and Romania get public financial support for 1 cycle and . public and private centres—2 countries; and public funding just for
.
in Kazakhstan for 1 cycle per year. In Bosnia and Herzegovina, Latvia . medications—3 countries (in Poland and Ukraine only for treatments
.
and Lithuania 2 cycles is the limit. In Austria, Bulgaria, Croatia, France . performed in public centres). As already stated, no public funding
.
and Iceland, up to 4 cycles are publicly supported. Hungary offers .
. at all is available in Albania, Armenia, Georgia and Switzerland
support for up to 5 cycles, and Belgium and Slovenia up to six. .
. (Supplementary Table SVIII).
.
Again, the situation in UK, with its regional particularities, precludes .
.
valuable detailed information. In Norway, there are a limited number . Must patients pay a proportion of costs of ART publicly funded
.
of cycles under public financial support but the actual number was not . cycles?. Patients in Bosnia and Herzegovina-Republic, Bulgaria,
.
communicated. . Croatia, Kazakhstan, Serbia (with the exception of cryopreservation),
.
Information on some countries deserves additional details. In Aus- .
. Russia, Slovenia and Spain do not pay a proportion of costs
tria, the subsidised number of cycles is per clinical pregnancy with no .
. of ART publicly funded cycles. In France, Greece and Latvia,
.
defined limit for the number of pregnancies. In Bulgaria, the upper . there are no costs regarding medications and the laboratory, but
.
limit refers to stimulated cycles (FER cycles are not limited) and can . patients may have to pay costs related to doctor/medical services
.
be substituted by up to 16 unstimulated cycles if the cost does not . (Supplementary Table SIX).
.
exceed that of four stimulated cycles. The limit in Denmark is three . Countries with public funding for medication can follow different
.
fresh embryo transfers or five started cycles (FER cycles not included). .
. systems as far as costs paid by patients are concerned: a settled
In Ireland and Poland, the public funding available refers to medication .
. maximum amount to be paid—seven countries; a fixed proportion of
.
only; in Ireland, the state supports the cost of medication with a 144 . the total cost—eight countries; costs above a defined limit—four coun-
.
euro exemption per monthly prescription. In The Netherlands, the . tries; depending on insurance contracts—two countries; and depend-
.
maximum number of cycles (n = 3) includes thawed cycles. Several . ing on local/regional Health Authority—two countries. In Romania,
.
countries have specific stipulations for situations of live birth resulting . national public funding does not cover any medication (except in the
.
from ART: Macedonia offers public support for 3 cycles for a first baby, .
. Bucharest region). No details were provided by Lithuania, Moldova and
.
3 cycles for a second and 3 cycles for a third one; in France, Hungary . Poland.
.
and Slovenia, four additional cycles are publicly funded for a second . As regards the two other areas of an IVF/ICSI cycle costs—
.
child after a successful treatment. . doctor/medical costs and laboratory costs—the situation is even more
.
Not all ART performed are entitled to benefit from public financial . complex, as shown in Supplementary Table SIX.
.
support in 19 countries. PGT is not funded in Bulgaria, Greece, Italy, .
.
Russia and Spain (in Spain only not supported for cases of repeated .
. Tax deductions. The possibility of getting tax deductions for expenses
.
implantation failure). Expenses related to donor cycles get no financial . resulting from ART can be considered another facet of financial public
.
assistance in Estonia, Montenegro and Russia. Cryopreservation of . assistance. Respondents identified that possibility in Germany (about
.
gametes and embryos is not publicly funded in the Czech Republic, . 20%), Ireland (20%), Italy (up to 19%), Latvia (maximum 250 euros),
.
Lithuania, Montenegro and Russia. In cases of premature ovarian . Portugal (associated with all other health expenses, until a legal maxi-
.
failure, egg donation is not publicly supported in Spain for women over . mum), Russia (13%), Austria, Switzerland (depends on the Canton of
.
36 years old. Iceland and Ukraine stated that only standard IVF/ICSI is .
. residence) and Ukraine (no details provided).
.
Waiting lists for IVF/ICSI. Waiting time for treatment is a negative . of Billari et al. (2011) who have concluded that the higher the social
.
factor in accessibility to ART. Our survey found that, not unexpect- . age norm for childbearing, the greater the availability of ART clinics.
.
edly, public centres have far longer lists than private ones. For . Exploring another perspective, Kocourkova et al. (2014) have reported
.
public centres, waiting time is between 12 and 24 months in Italy, . that ART use and the total fertility rate in a country are correlated,
.
Spain, Ukraine and some areas of Portugal, and 6–12 months in . which can be interpreted as a sign of increasing demand for children
.
.
Estonia, Denmark and the rest of Portugal. For private centres, . in that society. The associations between demographic and cultural
.
waiting lists of 12–24-month duration were communicated in Latvia, . factors, and the prevalence of ART in 35 European countries were
.
6–12 months in Estonia and Russia and less than 6 months in . the subject of a recent paper (Präg and Mills, 2017). The authors
.
Belgium, Bosnia and Herzegovina-Republic, Iceland, Ireland, Serbia . described a strong positive linear trend between the average ART
.
and Romania. No waiting time was reported in the remaining countries. . normative approval in a country and the number of treatments there.
.
. Their data also suggest that the greater the number of Protestants in
.
IUI. IUI is considered an ART under the national legislation of 35 .
. a country, the higher the use of ART; no relation was found between
countries (Supplementary Table SX). Allowed beneficiaries and resort .
. the proportion of Catholics in a population and ART usage. Although
to donor gametes follow the already described national characteristics. .
. a link between women’s higher educational status and reproductive
Public financial support was reported to exist in 14 countries. Limits .
. postponement has been established (Balbo et al., 2013), and the vari-
for public funding were described by France (up to six IUIs), Italy and .
. ation in the proportion of highly educated women across nations is
Portugal (up to three attempts). .
. a reality, no statistically significant relation between the percentage
.
.
. of middle-aged women with tertiary education and ART usage was
.
Registries .
.
apparent in this study. In the end, using a multiple regression model, the
. authors concluded that ART societal approval is effective in increasing
Some type of national registry of ART activity is in place in 32 out of the .
. ART usage only when a certain wealth level is reached in a coun-
43 countries participating in the survey, many of them reporting also .
. try.
on IUI (Supplementary Table SXI). Exceptions are Albania, Armenia, .
.
. The above studies have not explored social, cultural or religious
Cyprus, Estonia, Ireland, Latvia, Lithuania, Montenegro, Poland, Serbia .
. implications in other domains beyond the number of treatment cycles.
and Slovakia. The registry is mandatory in 26 of the 32 countries and .
. Both the couple and the gender requirements have great social rele-
organized by a Competent Authority in nine countries, the Ministry .
. vance as they seem to govern access to ART and IUI treatments over
of Health in nine, another governmental body in four, a professional .
. and above financial restrictions (Berg Brigham et al., 2013). Therefore,
association in seven and a committed volunteer in Iceland. In Belgium, .
. information on permitted techniques and candidates’ profiling is pivotal
Croatia and Spain, more than one body participates in the organization .
.
. in comprehending usage of those techniques at national levels. In this
of the registry. .
. context, third-party donation is a clear example, as well as surro-
A registry of donors exists in 16 countries (in France for egg donors .
. gacy and reproductive services for the transgender population. Our
only) and is mandatory in all of them except Iceland. It is organized .
. data show how differently European countries have dealt with these
by a Competent Authority in six countries, the Ministry of Health in .
. issues.
three, another governmental body in two, a professional association in .
. Inquiring into the preservation of reproductive potential has
Sweden and a committed volunteer in Iceland; information was missing .
.
. highlighted interesting findings. Cryopreservation of gametes, gonadal
for three countries. .
. tissue and embryos is performed virtually all over Europe (with some
.
. exceptions as far as embryos are concerned), even if no specific
.
. legal dispositions are in place, and public financial support apparently
Discussion .
. follows the same rules as ‘classical’ ART. On the other hand, oocyte
.
EIM reports have shown a great diversity in ART and IUI practice across . cryopreservation for non-medical reasons is not allowed in eight
.
.
Europe, not only in terms of treatment outcomes and the organization . countries and the availability of public funding is not clear in others.
.
of registry systems but also regarding the availability of techniques . Apparently, no significant change has occurred in this particular field
.
for infertile individuals in need. This survey details and updates the . since a previous report on the oocyte cryopreservation situation
.
information on ART and IUI regulations, public financial assistance and . (Shenfield et al., 2017).
.
registries in European countries on 31 December 2018. . Public financial assistance (be it either any model of statutory health
.
.
The information gathered confirms marked variations across—and . insurance or direct state funding) is quite variable across countries
.
sometimes within—countries. This does not mean actual absence . (and within some of them) resulting in important access inequities.
.
of legislation, as the practice of ART and IUI is regulated by legal . Those differences are mainly related to affordability but also to
.
norms (including European Union directives in Member States) in all . (more or less) restrictive age limits, with the acceptance (or not)
.
European countries, in spite of the absence of specific legislation in a . of patients who have already had children and/or to the number of
.
few. . publicly funded treatments. Although a relation between the generosity
.
.
It is undisputable that ART acceptance and usage in a particular . of a public health system and a country’s wealth generally exists,
.
country depends on a complexity of various aspects—financial, social, . there are some exceptions. A practical consequence of accessibility
.
cultural and religious—which are virtually impossible to disentangle. . difficulties in some countries and disparities between countries is
.
Studies focusing on the relation of the above dimensions with the . the increasing movement of people seeking treatments abroad—the
.
frequency of the utilisation of these therapeutic techniques have sug- . so-called cross-border reproductive care. Lower treatment costs,
.
gested several cultural normative values as relevant. This is the case . access to techniques not possible in the home-country, donated
.
14 130
Calhaz-Jorge et al.
.
gametes being more readily available and expectations of better- . Acknowledgements
.
quality treatments are the key drivers for this phenomenon. Data .
. The authors express a deep gratitude to all the EIM and CNR
on these relevant social circumstances are very scarce and limited .
. members that participated in this survey. Their invaluable con-
to only empirical information (Nygren et al., 2010) and one limited .
.
study (Shenfield et al., 2010). However, this is a reality of increasing . tribution was seminal for the quality and completeness of data
.
. presented.
importance, which raises some concerns about the possibility of .
.
exposing people to less controlled clinical environments. Furthermore, .
.
it leads to lack of tracking of reproductive cells across borders .
.
and limited knowledge of outcomes and hampers biovigilance by .
. Authors’ roles
national authorities. To overcome this problem, a new Code System .
. V.G. collected all data. C.C-J. did the analysis and wrote the manuscript.
was recently proposed (De Geyter et al., 2016). This European .
. All other co-authors reviewed the final manuscript and made appropri-
.
Reproductive Coding System would identify individuals (and their .
. ate corrections and suggestions to improve it.
reproductive material) travelling across Europe within a system .
.
of case-to-case data reporting to national ART data collecting .
.
institutions. .
.
The present paper is a descriptive approach to a very complex .
. Funding
reality, and the authors acknowledge some of its limitations. First, the .
. The study did not receive any external funding. All costs were covered
.
responses were provided by well-informed committed individuals but, . by ESHRE.
.
in spite of the checking and double-checking procedures adopted, we .
.
cannot assume that proper formal validation was in place. So, they .
.
mostly represent the perspective of clinicians and laboratory special- .
.
.
ists, i.e. they mirror the interpretation of the legislative documents .
. Conflict of interest
by hands-on experts, and possible inaccuracies cannot be excluded. .
. There are no competing interests.
Therefore, the data must be considered with some caution. Second, .
.
our results are a cross section in time as ART legislations undergo .
.
continuous evolution. For instance, Swedish law changed as recently as .
.
1 January 2019. Planned updates will yield important insights into the .
.
evolution of ART regulations over time, besides allowing correction of .
.
References
.
any inconsistencies. Third, in a few countries there is a distinction to be . Adamson GD. Global cultural and socioeconomic factors that influ-
.
made between current legislation and its application because ensuing . ence access to assisted reproductive technologies. Womens Health
.
regulation is not yet defined. This means that, in those countries, . 2009;5:351–358.
.
results presented may not necessarily imply the performance of a . Balbo N, Billari FC, Mills M. Fertility in advanced societies: a review of
.
technique (or its relevant usage) but rather a regulatory framework. . research. Eur J Population 2013;29:1–38.
.
Finally, several domains of ART and IUI activity were left out of the . Berg Brigham K, Cadier B, Chevreul K. The diversity of regulation and
.
.
scope of this ESHRE survey, such as donor/surrogate compensations, . public financing of IVF in Europe and its impact on utilization. Hum
.
monitoring mechanisms for governance and centre inspections or the . Reprod 2013;28:666–675.
.
definition of required couple characteristics (marriage, living in stable . Billari FC, Goisis A, Liefbroer AC, Settersten RA, Aassve A, Hagestad
.
relationship, for instance). Their inclusion will be considered for the . G, Spéder Z. Social age deadlines for the childbearing of women and
.
future. . men. Hum Reprod 2011 2011;26:616–622.
.
Notwithstanding, we obtained data from every European country in . De Geyter C, Wyns C, Mocanu E, de Mouzon J, Calhaz-Jorge C. Data
.
.
which ART is performed except one. Thus, this work represents the . collection systems in ART must follow the pace of change in clinical
.
most complete up-to-date overview of the European situation refer- . practice. Hum Reprod 2016;31:2160–2163.
.
ring to legislation, regulations, public financial assistance and registry . De Geyter C, Calhaz-Jorge C, Kupka MS, Wyns C, Mocanu E,
.
systems on ART and IUI in Europe so far. Furthermore, having been . Motrenko T, Scaravelli G, Smeenk J, Vidakovic S, Goossens V. Euro-
.
provided mainly by experts involved in the daily performance of those . pean IVF-monitoring consortium (EIM) for the European Society of
.
.
techniques reinforces its value for use in real life. . Human Reproduction and Embryology (ESHRE). ART in Europe,
.
In conclusion, this survey attests that the practice of ART and IUI . 2014: results generated from European registries by ESHRE: the
.
in Europe is framed by an impressive diversity of social acceptance . European IVF-monitoring consortium (EIM) for the European Soci-
.
and public financial systems and provides updated extensive answers . ety of Human Reproduction and Embryology (ESHRE). Hum Reprod
.
to many relevant questions in the use of ART at national level, which . 2018;33:1586–1601.
.
may hopefully contribute to patients’ information and to enriching . IFFS Surveillance. Global Reproductive Health 2016;2016:1:e1.
.
.
institutional and policymakers’ work. . Kocourkova J, Burcin B, Kucera T. Demographic relevancy of increased
.
. use of assisted reproduction in European countries. Reprod Health
.
. 2014;11:37.
.
. Nygren K, Adamson D, Zegers-Hochschild F, de Mouzon J. Inter-
Supplementary data .
.
. national committee monitoring assisted reproductive technologies.
Supplementary data are available at Human Reproduction Open. . Cross-border fertility care–International Committee Monitoring
.
.
Assisted Reproductive Technologies global survey: 2006 data and . reproductive care. Cross border reproductive care in six European
.
estimates. Fertil Steril 2010;94:e4–e10. . countries. Hum Reprod 2010;25:1361–1368.
.
Präg P, Mills MC. Cultural determinants influence assisted reproduction . Shenfield F, de Mouzon J, Scaravelli G, Kupka M, Ferraretti AP, Prados
.
usage in Europe more than economic and demographic factors. Hum . FJ, Goossens V. The ESHRE Working Group on Oocyte Cryop-
.
Reprod 2017;32:2305–2314. . reservation in Europe. Oocyte and ovarian tissue cryopreservation
.
Shenfield F, de Mouzon J, Pennings G, Ferraretti AP, Andersen AN, . in European countries: statutory background, practice, storage and
.
.
de Wert G, Goossens V; The ESHRE taskforce on cross border . use. Hum Reprod Open 2017;1:1–9.
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Annexure P/3
132
Repetitive oocyte donation: a
committee opinion
Practice Committee of the American Society for Reproductive Medicine and Practice Committee of the
Society for Assisted Reproductive Technology
Practice Committees of the American Society for Reproductive Medicine and Society for Assisted Reproductive Technology,
Birmingham, Alabama
Donors should be advised of the number of cycles/donations that a given oocyte donor may undergo. Although existing data cannot
permit conclusive recommendations, concern for the issues of safety and well-being of oocyte donors warrants consideration. This
document replaces the document of the same name, previously published in 2014. (Fertil SterilÒ 2020;113:1150–3. Ó2020 by American
Society for Reproductive Medicine.)
El resumen está disponible en Español al final del artículo.
Discuss: You can discuss this article with its authors and other readers at https://www.fertstertdialog.com/users/16110-fertility-
and-sterility/posts/63745-30070
D
onor cycles are relatively com- through a sense of altruism and/or are the product of donated gametes
mon in assisted reproductive financial compensation for her ser- and maintaining a limit of no more
technology (ART), and the vices. Therefore, the question arises of than 25 pregnancies per sperm donor
number of donor cycles using fresh whether the number of times that a in a catchment area of 800,000 resi-
and frozen oocytes was more than given oocyte donor might donate her dences to minimize the risk of consan-
7,800 cycles in 2016 in the United gametes should be limited. Despite the guinity (2–4). Subsequent studies have
States (1). Women may choose to absence of definitive, long-term commented that additional factors,
donate oocytes more than one time, follow-up data, there has nonetheless including the lifting of donor
giving rise to concerns about the been motivation on the part of ART anonymity, genetic carrier screening,
optimal number of times that each practitioners to develop a consensus and social changes in mobility and
woman should donate, both to protect for a prudent approach. Unusual cir- attitude, could further reduce the risk
the health of the donor and to avoid is- cumstances should be considered on of inadvertent consanguinity (5–7).
sues of consanguinity. This discussion an individual basis before surpassing Given that oocyte donation is a
will address the issue of whether limits the maximum number of donations complex process and may result in
should be advised on the number of proposed by these suggested limits. cryopreserved oocytes, embryos, and
cycles/donations that a given oocyte an unpredictable number of
donor may undergo. Although existing pregnancies over a long period of time
data cannot permit conclusive recom- RISKS OF INADVERTENT and a wide geographical region, it is
mendations, concern for the safety CONSANGUINITY reasonable to also limit the number of
and the well-being of oocyte donors Inadvertent consanguinity resulting oocyte donations rather than the
warrants consideration. from oocyte donation could occur if a number of resulting pregnancies. The
The practice of oocyte donation has given donor has donated to two or suggestions outlined here may require
potential risks for the donor, including modification if the population using
more unrelated families and the
the risks associated with ovarian stimu- donor gametes represents an isolated
offspring are unaware of their specific
lation, the oocyte retrieval procedure, subgroup or the specimens are
genetic heritage. Previous documents
and anesthesia, among others. distributed over a particularly small
on donor insemination published by
Although the recipient derives a clear geographic area.
the American Society for Reproductive
and tangible benefit from oocyte dona-
Medicine (ASRM) and others have
tion, the donor derives benefit only
advised informing offspring that they HEALTH RISKS TO THE
Received March 17, 2020; accepted March 20, 2020. OOCYTE DONOR
Correspondence: Practice Committee, American Society for Reproductive Medicine, 1209 Montgom- Ovarian Stimulation
ery Highway, Birmingham, Alabama 35216 (E-mail: [email protected]).
Ovarian stimulation entails both
Fertility and Sterility® Vol. 113, No. 6, June 2020 0015-0282/$36.00
Copyright ©2020 American Society for Reproductive Medicine, Published by Elsevier Inc.
known and potential risks. The risk of
https://doi.org/10.1016/j.fertnstert.2020.03.030 severe ovarian hyperstimulation
1150 VOL. 113 NO. 6 / JUNE 2020

133
Fertility and Sterility®
syndrome (OHSS) is reported to be approximately 1% to 2% with children conceived from their gametes in the future.
per retrieval cycle. The incidence and severity of OHSS may These issues should be addressed during appropriate pretreat-
in fact be lower in oocyte donors (8), in part owing to the ment screening and counseling (20).
absence of conception after stimulation. The use of a
gonadotropin-releasing hormone (GnRH) agonist to induce RISK ASSESSMENT: MAXIMUM NUMBER OF
final oocyte maturation compared with the traditional use CYCLES PER OOCYTE DONOR
of human chorionic gonadotropin (hCG) has been shown to
Previous expert opinion has suggested a limit of six cycles per
dramatically reduce the risk of developing OHSS in oocyte
donor (21–24), a recommendation that this document
donors in both large retrospective and smaller prospective
continues to support. The basis for this recommendation is
studies (9–12).
rooted in a concern over the potential cumulative risk
accrued after a donor undergoes six ovarian-stimulation
Acute Procedural Risks and egg-retrieval procedures. In a single ovarian-
There are real, albeit small (<0.5%), risks of acute complica- stimulation cycle, the donor’s risk of severe OHSS is reported
tions, including pelvic infection, intraperitoneal hemorrhage, to be approximately 1% to 2% per retrieval cycle, and the risk
or ovarian torsion (9, 13, 14). The risks associated with the low of acute complications, including pelvic infection, intraperi-
levels of anesthesia generally employed for oocyte retrieval in toneal hemorrhage, or ovarian torsion, is estimated at
a young, healthy population should be very small. However, <0.5%. Cumulatively, after six donation cycles, these risks
idiosyncratic reactions to anesthetic agents and other anes- to an individual donor aggregate to an overall risk of 8% to
thetic complications (e.g., aspiration) may occur. 13% of a serious adverse event, recognizing that this will
vary among individuals. Further, it is reasonable to assume
Cancer that some egg donors will require fertility services themselves,
including in vitro fertilization, at a rate proportional to the
The preponderance of data does not demonstrate an associa- general population stratified by age. Therefore, it may be pru-
tion between the use of ovarian-stimulation agents and can- dent to limit the number of stimulated cycles for an individual
cer, including invasive ovarian and breast cancers (15–17). donor to no more than six.
Moreover, the current understanding of the pathogenesis of
ovarian cancer is rapidly evolving, calling into question
traditional theories of the relationship between nulliparity
SUMMARY
and ovarian cancer (18). Oocyte donors are exposed to the risks attendant to ovarian
stimulation, oocyte retrieval, and anesthesia.
Future Ovarian Reserve of the Donor Severe OHSS is estimated to occur in 1% to 2% of donation
It is not presently known whether repetitive follicular aspira- cycles, but the risk may be further reduced by the use of
tions affect the donor's future ovarian reserve. However, the GnRH agonists for triggering final oocyte maturation.
physiologic mechanism of oocyte recruitment in ovarian The risk of serious acute complications associated with
stimulation is a reduction in follicles destined for atresia. Pre- these procedures is small (<0.5%).
liminary data indicate that repetitive and multiple cycles of The preponderance of data does not demonstrate a signi-
oocyte donation do not decrease the donor's ovarian reserve, ficant risk of future cancers in women undergoing stimula-
as assessed by serum antim€ ullerian hormone levels (19). tion and egg retrieval.
The data are limited, but available evidence does not sug-
gest that oocyte donation is associated with changes in
Psychological Risks the donor's ovarian reserve.
Oocyte donation may entail potential psychological risks
(ambivalence, regret, etc.) that might occur around the time
of the procedure or years later. CONCLUSION
Currently, there are no clearly documented long-term risks
Loss of Intended Anonymity associated with oocyte donation, and as such, no definitive
data upon which to base absolute recommendations. Further-
Direct-to-consumer DNA testing, genealogy databases, and more, there is a paucity of long-term follow-up data for repeat
social media offer the opportunity to identify genetic connec- oocyte donors. However, because of the possible cumulative
tions to relatives with whom a consumer may or may not have risks to and future needs of an individual donor, as outlined
a personal relationship. Despite the intention of anonymity, in the preceding discussion, it may be reasonable and prudent
egg donors should be counseled that their anonymity could to limit the number of stimulated cycles for a given oocyte
be compromised if their DNA or that of a close relative is donor to no more than six. These recommendations will inev-
added to a database. Although donors have control over their itably be modified as new data become available.
own participation in direct-to-consumer DNA testing, rela-
tives of donors and donor-conceived offspring who choose Acknowledgments: This report was developed under the
to participate may find themselves linked. This may permit direction of the Practice Committee of the American Society
the recipient or donor-conceived offspring to deduce the for Reproductive Medicine (ASRM) in collaboration with the
identity of the donor, leading to unanticipated contact Society for Assisted Reproductive Technology (SART) as a
VOL. 113 NO. 6 / JUNE 2020 1151

ASRM PAGES 134
service to its members and other practicing clinicians. 6. Janssens PM. No reason for a reduction in the number of offspring per sperm
Although this document reflects appropriate management donor because of possible transmission of autosomal dominant diseases.
Hum Reprod 2003;18:669–71.
of a problem encountered in the practice of reproductive med-
7. Sawyer N, McDonald J. A review of mathematical models used to determine
icine, it is not intended to be the only approved standard of sperm donor limits for infertility treatment. Fertil Steril 2008;90:265–71.
practice or to dictate an exclusive course of treatment. Other 8. Sauer MV, Paulson RJ, Lobo RA. Rare occurrence of ovarian hyperstimulation
plans of management may be appropriate, taking into ac- syndrome in oocyte donors. Int J Gynaecol Obstet 1996;52:259–62.
count the needs of the individual patient, available resources, 9. Bodri D, Guillen JJ, Polo A, Trullenque M, Esteve C, Coll O. Complications
and institutional or clinical practice limitations. The Practice related to ovarian stimulation and oocyte retrieval in 2052 oocyte donor
Committees and the Board of Directors of ASRM and SART cycles. Reprod Biomed Online 2008;17:237–43.
10. Galindo A, Bodri D, Guillen JJ, Colodron M, Vernaeve V, Coll O. Ovulation
have approved this report.
triggering with GnRH agonist vs. hCG in the same egg donor population
This document was reviewed by ASRM members, and undergoing donor oocyte cycles with GnRH antagonist: a prospective
their input was considered in the preparation of the final randomized cross-over trial. J Assist Reprod Genet 2009;26:251–6.
document. The Practice Committee acknowledges the special 11. Melo M, Busso CE, Bellver J, Alama P, Garrido N, Meseguer M, et al. GnRH
contribution of Anthony Propst, M.D., in the preparation of agonist versus recombinant HCG in an oocyte donation programme: a
this document. The following members of the ASRM Practice randomized, prospective, controlled, assessor-blind study. Reprod Biomed
Online 2009;19:486–92.
Committee participated in the development of this document.
12. Practice Committee of the American Society for Reproductive Medicine. Pre-
All Committee members disclosed commercial and financial vention and treatment of moderate and severe ovarian hyperstimulation
relationships with manufacturers or distributors of goods or syndrome: a guideline. Fertil Steril 2016;106:1634–47.
services used to treat patients. Members of the Committee 13. Bennett SJ, Waterstone JJ, Cheng WC, Parsons J. Complications of transva-
who were found to have conflicts of interest based on the ginal ultrasound-directed follicle aspirations: a review of 2670 consecutive
relationships disclosed did not participate in the discussion procedures. J Assist Reprod Genet 1993;10:72–7.
or development of this document. 14. Ludwig AK, Glawatz M, Griesinger G, Diedrich K, Ludwig M. Perioperative
and post-operative complications of transvaginal ultrasound-guided oocyte
Alan Penzias, M.D.; Ricardo Azziz, M.D., M.P.H., M.B.A.;
retrieval: prospective study of >1000 oocyte retrievals. Hum Reprod 2006;
Kristin Bendikson, M.D.; Samantha Butts, M.D., M.S.C.E.; 21:3235–40.
Tommaso Falcone, M.D.; Susan Gitlin, Ph.D.; Clarisa Gracia, 15. Venn A, Watson L, Lumley J, Giles G, King C, Healy D. Breast and ovarian
M.D., M.S.C.E.; Karl Hansen, M.D., Ph.D.; Micah Hill, D.O.; cancer incidence after infertility and in vitro fertilization. Lancet 1995;346:
William Hurd, M.D., M.P.H.; Sangita Jindal, Ph.D.; Suleena 995–1000.
Kalra, M.D., M.S.C.E.; Jennifer Mersereau, M.D.; Randall 16. Brinton LA, Sahasrabuddhe VV, Scoccia B. Fertility drugs and the risk of
Odem, M.D.; Robert Rebar, M.D.; Richard Reindollar, M.D.; breast and gynecologic cancers. Semin Reprod Med 2012;30:131–45.
17. Practice Committee of the American Society for Reproductive Medicine.
Catherine Racowsky, Ph.D.; Mitchell Rosen, M.D.; Jay
Fertility drugs and cancer: a guideline. Fertil Steril 2016;106:1617–26.
Sandlow, M.D.; Peter Schlegel, M.D.; Anne Steiner, M.D., 18. Vaughan S, Coward JI, Bast RC Jr, Berchuck A, Berek JS, Brenton JD, et al.
M.P.H.; Dale Stovall, M.D.; and Cigdem Tanrikut, M.D. Rethinking ovarian cancer: recommendations for improving outcomes.
Nat Rev Cancer 2011;11:719–25.
19. Bukulmez O, Li Q, Carr BR, Leader B, Doody KM, Doody KJ. Repetitive oocyte
REFERENCES donation does not decrease serum anti-mu €llerian hormone levels. Fertil Steril
1. Society for Assisted Reproductive Technology. Clinic Summary Report 2015. 2010;94:905–12.
Available at: https://www.sartcorsonline.com/rptCSR_PublicMultYear. 20. Harper JC, Kennett D, Reisel D. The end of donor anonymity: how genetic
aspx?reportingYear¼2016. testing is likely to drive anonymous gamete donation out of business.
2. De Boer A, Oosterwijk JC, Rigters-Aris CA. Determination of a maximum Hum Reprod 2016;31:1135–40.
number of artificial inseminations by donor children per sperm donor. Fertil 21. Practice Committee of the American Society for Reproductive Medicine and
Steril 1995;63:419–21. Practice Committee of the Society for Assisted Reproductive Technology. Re-
3. Curie-Cohen M. The frequency of consanguineous matings due to multiple petitive oocyte donation: a committee opinion. Fertil Steril 2014;102:964–6.
use of donors in artificial insemination. Am J Hum Genet 1980;32:589–600. 22. Practice Committee of American Society for Reproductive Medicine. Repet-
4. Practice Committee of the American Society for Reproductive Medicine. itive oocyte donation. Fertil Steril 2008;90(Suppl):S194–5.
Guidelines for therapeutic donor insemination. Fertil Steril 1998;70:1–4. 23. Practice Committee of the American Society for Reproductive Medicine.
5. Ethics Committee of the American Society for Reproductive Medicine. Repetitive oocyte donation. Fertil Steril 2006;86(Suppl):S216–7.
Informing offspring of their conception by gamete or embryo donation: 24. Practice Committee of the American Society for Reproductive Medicine.
an Ethics Committee opinion. Fertil Steril 2018;109:601–5. Repetitive oocyte donation. Fertil Steril 2004;82(Suppl):S158–9.
1152 VOL. 113 NO. 6 / JUNE 2020

135
Donacion repetitiva de ovocitos: una opinion del comite

Las donantes deben de ser informadas sobre el nu mero de ciclos / donaciones a las que una donante de ovocitos puede someterse.
Aunque los datos existentes no permiten realizar recomendaciones concluyentes, la preocupaci on por los temas de seguridad y
bienestar de las donantes de ovocitos merecen tenerlo en consideraci on. Este documento reemplaza al documento del mismo
nombre, publicado anteriormente en 2014
VOL. 113 NO. 6 / JUNE 2020 1153

136
Repetitive oocyte donation: a
committee opinion
Practice Committee of the American Society for Reproductive Medicine and Practice Committee of the
Society for Assisted Reproductive Technology
Practice Committees of the American Society for Reproductive Medicine and Society for Assisted Reproductive Technology,
Birmingham, Alabama
Donors should be advised of the number of cycles/donations that a given oocyte donor may undergo. Although existing data cannot
permit conclusive recommendations, concern for the issues of safety and well-being of oocyte donors warrants consideration. This
document replaces the document of the same name, previously published in 2014. (Fertil SterilÒ 2020;113:1150–3. Ó2020 by American
Society for Reproductive Medicine.)
Discuss: You can discuss this article with its authors and other readers at https://www.fertstertdialog.com/users/16110-fertility-
and-sterility/posts/63745-30070
D
onor cycles are relatively com- through a sense of altruism and/or are the product of donated gametes
mon in assisted reproductive financial compensation for her ser- and maintaining a limit of no more
technology (ART), and the vices. Therefore, the question arises of than 25 pregnancies per sperm donor
number of donor cycles using fresh whether the number of times that a in a catchment area of 800,000 resi-
and frozen oocytes was more than given oocyte donor might donate her dences to minimize the risk of consan-
7,800 cycles in 2016 in the United gametes should be limited. Despite the guinity (2–4). Subsequent studies have
States (1). Women may choose to absence of definitive, long-term commented that additional factors,
donate oocytes more than one time, follow-up data, there has nonetheless including the lifting of donor
giving rise to concerns about the been motivation on the part of ART anonymity, genetic carrier screening,
optimal number of times that each practitioners to develop a consensus and social changes in mobility and
woman should donate, both to protect for a prudent approach. Unusual cir- attitude, could further reduce the risk
the health of the donor and to avoid is- cumstances should be considered on of inadvertent consanguinity (5–7).
sues of consanguinity. This discussion an individual basis before surpassing Given that oocyte donation is a
will address the issue of whether limits the maximum number of donations complex process and may result in
should be advised on the number of proposed by these suggested limits. cryopreserved oocytes, embryos, and
cycles/donations that a given oocyte an unpredictable number of
donor may undergo. Although existing pregnancies over a long period of time
data cannot permit conclusive recom- RISKS OF INADVERTENT and a wide geographical region, it is
mendations, concern for the safety CONSANGUINITY reasonable to also limit the number of
and the well-being of oocyte donors Inadvertent consanguinity resulting oocyte donations rather than the
warrants consideration. from oocyte donation could occur if a number of resulting pregnancies. The
The practice of oocyte donation has given donor has donated to two or suggestions outlined here may require
potential risks for the donor, including modification if the population using
more unrelated families and the
the risks associated with ovarian stimu- donor gametes represents an isolated
offspring are unaware of their specific
lation, the oocyte retrieval procedure, subgroup or the specimens are
genetic heritage. Previous documents
and anesthesia, among others. distributed over a particularly small
on donor insemination published by
Although the recipient derives a clear geographic area.
the American Society for Reproductive
and tangible benefit from oocyte dona-
Medicine (ASRM) and others have
tion, the donor derives benefit only
advised informing offspring that they HEALTH RISKS TO THE
Received March 17, 2020; accepted March 20, 2020. OOCYTE DONOR
Correspondence: Practice Committee, American Society for Reproductive Medicine, 1209 Montgom- Ovarian Stimulation
ery Highway, Birmingham, Alabama 35216 (E-mail: [email protected]).
Ovarian stimulation entails both
Fertility and Sterility® Vol. 113, No. 6, June 2020 0015-0282/$36.00
known and potential risks. The risk of
https://doi.org/10.1016/j.fertnstert.2020.03.030 severe ovarian hyperstimulation
1150 VOL. 113 NO. 6 / JUNE 2020

137
syndrome (OHSS) is reported to be approximately 1% to 2% with children conceived from their gametes in the future.
per retrieval cycle. The incidence and severity of OHSS may These issues should be addressed during appropriate pretreat-
in fact be lower in oocyte donors (8), in part owing to the ment screening and counseling (20).
absence of conception after stimulation. The use of a
gonadotropin-releasing hormone (GnRH) agonist to induce RISK ASSESSMENT: MAXIMUM NUMBER OF
final oocyte maturation compared with the traditional use CYCLES PER OOCYTE DONOR
of human chorionic gonadotropin (hCG) has been shown to
Previous expert opinion has suggested a limit of six cycles per
dramatically reduce the risk of developing OHSS in oocyte
donor (21–24), a recommendation that this document
donors in both large retrospective and smaller prospective
continues to support. The basis for this recommendation is
studies (9–12).
rooted in a concern over the potential cumulative risk
accrued after a donor undergoes six ovarian-stimulation
Acute Procedural Risks and egg-retrieval procedures. In a single ovarian-
There are real, albeit small (<0.5%), risks of acute complica- stimulation cycle, the donor’s risk of severe OHSS is reported
tions, including pelvic infection, intraperitoneal hemorrhage, to be approximately 1% to 2% per retrieval cycle, and the risk
or ovarian torsion (9, 13, 14). The risks associated with the low of acute complications, including pelvic infection, intraperi-
levels of anesthesia generally employed for oocyte retrieval in toneal hemorrhage, or ovarian torsion, is estimated at
a young, healthy population should be very small. However, <0.5%. Cumulatively, after six donation cycles, these risks
idiosyncratic reactions to anesthetic agents and other anes- to an individual donor aggregate to an overall risk of 8% to
thetic complications (e.g., aspiration) may occur. 13% of a serious adverse event, recognizing that this will
vary among individuals. Further, it is reasonable to assume
Cancer that some egg donors will require fertility services themselves,
including in vitro fertilization, at a rate proportional to the
The preponderance of data does not demonstrate an associa- general population stratified by age. Therefore, it may be pru-
tion between the use of ovarian-stimulation agents and can- dent to limit the number of stimulated cycles for an individual
cer, including invasive ovarian and breast cancers (15–17). donor to no more than six.
Moreover, the current understanding of the pathogenesis of
ovarian cancer is rapidly evolving, calling into question
traditional theories of the relationship between nulliparity
SUMMARY
and ovarian cancer (18). Oocyte donors are exposed to the risks attendant to ovarian
stimulation, oocyte retrieval, and anesthesia.
Future Ovarian Reserve of the Donor Severe OHSS is estimated to occur in 1% to 2% of donation
It is not presently known whether repetitive follicular aspira- cycles, but the risk may be further reduced by the use of
tions affect the donor's future ovarian reserve. However, the GnRH agonists for triggering final oocyte maturation.
physiologic mechanism of oocyte recruitment in ovarian The risk of serious acute complications associated with
stimulation is a reduction in follicles destined for atresia. Pre- these procedures is small (<0.5%).
liminary data indicate that repetitive and multiple cycles of The preponderance of data does not demonstrate a signi-
oocyte donation do not decrease the donor's ovarian reserve, ficant risk of future cancers in women undergoing stimula-
as assessed by serum antim€ ullerian hormone levels (19). tion and egg retrieval.
The data are limited, but available evidence does not sug-
gest that oocyte donation is associated with changes in
Psychological Risks the donor's ovarian reserve.
Oocyte donation may entail potential psychological risks
(ambivalence, regret, etc.) that might occur around the time
of the procedure or years later. CONCLUSION
Currently, there are no clearly documented long-term risks
Loss of Intended Anonymity associated with oocyte donation, and as such, no definitive
data upon which to base absolute recommendations. Further-
Direct-to-consumer DNA testing, genealogy databases, and more, there is a paucity of long-term follow-up data for repeat
social media offer the opportunity to identify genetic connec- oocyte donors. However, because of the possible cumulative
tions to relatives with whom a consumer may or may not have risks to and future needs of an individual donor, as outlined
a personal relationship. Despite the intention of anonymity, in the preceding discussion, it may be reasonable and prudent
egg donors should be counseled that their anonymity could to limit the number of stimulated cycles for a given oocyte
be compromised if their DNA or that of a close relative is donor to no more than six. These recommendations will inev-
added to a database. Although donors have control over their itably be modified as new data become available.
own participation in direct-to-consumer DNA testing, rela-
tives of donors and donor-conceived offspring who choose Acknowledgments: This report was developed under the
to participate may find themselves linked. This may permit direction of the Practice Committee of the American Society
the recipient or donor-conceived offspring to deduce the for Reproductive Medicine (ASRM) in collaboration with the
identity of the donor, leading to unanticipated contact Society for Assisted Reproductive Technology (SART) as a
VOL. 113 NO. 6 / JUNE 2020 1151

ASRM PAGES 138
service to its members and other practicing clinicians. 6. Janssens PM. No reason for a reduction in the number of offspring per sperm
Although this document reflects appropriate management donor because of possible transmission of autosomal dominant diseases.
Hum Reprod 2003;18:669–71.
of a problem encountered in the practice of reproductive med-
7. Sawyer N, McDonald J. A review of mathematical models used to determine
icine, it is not intended to be the only approved standard of sperm donor limits for infertility treatment. Fertil Steril 2008;90:265–71.
practice or to dictate an exclusive course of treatment. Other 8. Sauer MV, Paulson RJ, Lobo RA. Rare occurrence of ovarian hyperstimulation
plans of management may be appropriate, taking into ac- syndrome in oocyte donors. Int J Gynaecol Obstet 1996;52:259–62.
count the needs of the individual patient, available resources, 9. Bodri D, Guillen JJ, Polo A, Trullenque M, Esteve C, Coll O. Complications
and institutional or clinical practice limitations. The Practice related to ovarian stimulation and oocyte retrieval in 2052 oocyte donor
Committees and the Board of Directors of ASRM and SART cycles. Reprod Biomed Online 2008;17:237–43.
10. Galindo A, Bodri D, Guillen JJ, Colodron M, Vernaeve V, Coll O. Ovulation
have approved this report.
triggering with GnRH agonist vs. hCG in the same egg donor population
This document was reviewed by ASRM members, and undergoing donor oocyte cycles with GnRH antagonist: a prospective
their input was considered in the preparation of the final randomized cross-over trial. J Assist Reprod Genet 2009;26:251–6.
document. The Practice Committee acknowledges the special 11. Melo M, Busso CE, Bellver J, Alama P, Garrido N, Meseguer M, et al. GnRH
contribution of Anthony Propst, M.D., in the preparation of agonist versus recombinant HCG in an oocyte donation programme: a
this document. The following members of the ASRM Practice randomized, prospective, controlled, assessor-blind study. Reprod Biomed
Online 2009;19:486–92.
Committee participated in the development of this document.
12. Practice Committee of the American Society for Reproductive Medicine. Pre-
All Committee members disclosed commercial and financial vention and treatment of moderate and severe ovarian hyperstimulation
relationships with manufacturers or distributors of goods or syndrome: a guideline. Fertil Steril 2016;106:1634–47.
services used to treat patients. Members of the Committee 13. Bennett SJ, Waterstone JJ, Cheng WC, Parsons J. Complications of transva-
who were found to have conflicts of interest based on the ginal ultrasound-directed follicle aspirations: a review of 2670 consecutive
relationships disclosed did not participate in the discussion procedures. J Assist Reprod Genet 1993;10:72–7.
or development of this document. 14. Ludwig AK, Glawatz M, Griesinger G, Diedrich K, Ludwig M. Perioperative
and post-operative complications of transvaginal ultrasound-guided oocyte
Alan Penzias, M.D.; Ricardo Azziz, M.D., M.P.H., M.B.A.;
retrieval: prospective study of >1000 oocyte retrievals. Hum Reprod 2006;
Kristin Bendikson, M.D.; Samantha Butts, M.D., M.S.C.E.; 21:3235–40.
Tommaso Falcone, M.D.; Susan Gitlin, Ph.D.; Clarisa Gracia, 15. Venn A, Watson L, Lumley J, Giles G, King C, Healy D. Breast and ovarian
M.D., M.S.C.E.; Karl Hansen, M.D., Ph.D.; Micah Hill, D.O.; cancer incidence after infertility and in vitro fertilization. Lancet 1995;346:
William Hurd, M.D., M.P.H.; Sangita Jindal, Ph.D.; Suleena 995–1000.
Kalra, M.D., M.S.C.E.; Jennifer Mersereau, M.D.; Randall 16. Brinton LA, Sahasrabuddhe VV, Scoccia B. Fertility drugs and the risk of
Odem, M.D.; Robert Rebar, M.D.; Richard Reindollar, M.D.; breast and gynecologic cancers. Semin Reprod Med 2012;30:131–45.
17. Practice Committee of the American Society for Reproductive Medicine.
Catherine Racowsky, Ph.D.; Mitchell Rosen, M.D.; Jay
Fertility drugs and cancer: a guideline. Fertil Steril 2016;106:1617–26.
Sandlow, M.D.; Peter Schlegel, M.D.; Anne Steiner, M.D., 18. Vaughan S, Coward JI, Bast RC Jr, Berchuck A, Berek JS, Brenton JD, et al.
M.P.H.; Dale Stovall, M.D.; and Cigdem Tanrikut, M.D. Rethinking ovarian cancer: recommendations for improving outcomes.
Nat Rev Cancer 2011;11:719–25.
19. Bukulmez O, Li Q, Carr BR, Leader B, Doody KM, Doody KJ. Repetitive oocyte
REFERENCES donation does not decrease serum anti-mu €llerian hormone levels. Fertil Steril
1. Society for Assisted Reproductive Technology. Clinic Summary Report 2015. 2010;94:905–12.
Available at: https://www.sartcorsonline.com/rptCSR_PublicMultYear. 20. Harper JC, Kennett D, Reisel D. The end of donor anonymity: how genetic
aspx?reportingYear¼2016. testing is likely to drive anonymous gamete donation out of business.
2. De Boer A, Oosterwijk JC, Rigters-Aris CA. Determination of a maximum Hum Reprod 2016;31:1135–40.
number of artificial inseminations by donor children per sperm donor. Fertil 21. Practice Committee of the American Society for Reproductive Medicine and
Steril 1995;63:419–21. Practice Committee of the Society for Assisted Reproductive Technology. Re-
3. Curie-Cohen M. The frequency of consanguineous matings due to multiple petitive oocyte donation: a committee opinion. Fertil Steril 2014;102:964–6.
use of donors in artificial insemination. Am J Hum Genet 1980;32:589–600. 22. Practice Committee of American Society for Reproductive Medicine. Repet-
4. Practice Committee of the American Society for Reproductive Medicine. itive oocyte donation. Fertil Steril 2008;90(Suppl):S194–5.
Guidelines for therapeutic donor insemination. Fertil Steril 1998;70:1–4. 23. Practice Committee of the American Society for Reproductive Medicine.
5. Ethics Committee of the American Society for Reproductive Medicine. Repetitive oocyte donation. Fertil Steril 2006;86(Suppl):S216–7.
Informing offspring of their conception by gamete or embryo donation: 24. Practice Committee of the American Society for Reproductive Medicine.
an Ethics Committee opinion. Fertil Steril 2018;109:601–5. Repetitive oocyte donation. Fertil Steril 2004;82(Suppl):S158–9.
1152 VOL. 113 NO. 6 / JUNE 2020

139
Donacion repetitiva de ovocitos: una opinion del comite

Las donantes deben de ser informadas sobre el nu mero de ciclos / donaciones a las que una donante de ovocitos puede someterse.
Aunque los datos existentes no permiten realizar recomendaciones concluyentes, la preocupaci on por los temas de seguridad y
bienestar de las donantes de ovocitos merecen tenerlo en consideraci on. Este documento reemplaza al documento del mismo
nombre, publicado anteriormente en 2014
VOL. 113 NO. 6 / JUNE 2020 1153

ASRM PAGES 140
Oocyte or embryo donation to women
of advanced reproductive age:
an Ethics Committee opinion
Ethics Committee of the American Society for Reproductive Medicine
American Society for Reproductive Medicine, Birmingham, Alabama
Advanced reproductive age (ARA) is a risk factor for female infertility, pregnancy loss, fetal anomalies, stillbirth, and obstetric com-
plications. Oocyte donation reverses the age-related decline in implantation and birth rates of women in their 40s and 50s and restores
pregnancy potential beyond menopause. However, obstetrical complications in older patients remain high, particularly related to oper-
ative delivery and hypertensive and cardiovascular risks. Physicians should perform a thorough medical evaluation designed to assess
the physical fitness of a patient for pregnancy before deciding to attempt transfer of embryos to any woman of advanced reproductive
age (>45 years). Embryo transfer should be strongly discouraged or denied to women of ARA with underlying conditions that increase
or exacerbate obstetrical risks. Because of concerns related to the high-risk nature of pregnancy, as well as longevity, treatment of
women over the age of 55 should generally be discouraged. This statement replaces the earlier ASRM Ethics Committee document
of the same name, last published in 2013 (Fertil Steril 2013;100:337–40). (Fertil SterilÒ 2016;106:e3–7. Ó2016 by American Society
for Reproductive Medicine.)
Key Words: Ethics, third-party reproduction, complications, pregnancy, parenting
Discuss: You can discuss this article with its authors and with other ASRM members at https://www.fertstertdialog.com/users/
16110-fertility-and-sterility/posts/10968-oocyte-or-embryo-donation-to-women-of-advanced-reproductive-age-an-ethics-
committee-opinion
KEY POINTS Prospective ARA patients should be embryos to women over 55 years of
counseled about the increased medi- age, even when they have no under-
Oocyte and embryo donation is an cal risks related to pregnancy, and lying medical problems, should be
established standard of practice for that many of these risks are poorly discouraged.
the treatment of age-related infer- characterized due to lack of data. Multiple pregnancy significantly in-
tility and is associated with high The counseling process should creases the risks associated with
rates of pregnancy success. involve the participation of a physi- pregnancy and delivery; therefore,
Adverse obstetrical events and out- cian familiar with managing high- elective single embryo transfer
comes are associated with advanced risk pregnancy. (eSET) is the preferred method of
reproductive age (ARA), particularly Oocyte and embryo donation should treatment in ARA women.
related to operative delivery, hyper- be strongly discouraged if underly- Prospective older parents should be
tensive disorders, gestational dia- ing medical conditions that could counseled regarding short- and
betes, and perinatal mortality. further increase the obstetrical and long-term parenting and child-
Women of ARA considering oocyte neonatal risks are present, particu- rearing issues specific to their age.
or embryo donation should undergo larly hypertension or diabetes. The age and health of the partner, if
comprehensive medical testing In view of the limited data regarding present, should also be considered
focused on ascertaining cardiovas- maternal and fetal safety, as well as in this discussion.
cular and metabolic fitness, as well concerns related to longevity and It is ethically permissible for pro-
as a psychosocial evaluation to the need for adequate psychosocial grams to decline to provide treat-
determine if adequate supports are supports for raising a child to adult- ment to women of ARA based on
in place to raise a child to adulthood. hood, providing donor oocytes or concerns over the health and well-
being of the patient and offspring.
Received July 1, 2016; accepted July 1, 2016; published online July 20, 2016. The reported success of oocyte
Reprint requests: Ethics Committee, American Society for Reproductive Medicine, 1209 Montgomery
Hwy, Birmingham, Alabama 35216 (E-mail: [email protected]). donation to women in their 50s (1, 2)
and early 60s (3, 4) suggests that
Fertility and Sterility® Vol. 106, No. 5, October 2016 0015-0282/$36.00 pregnancy may be possible in
http://dx.doi.org/10.1016/j.fertnstert.2016.07.002 virtually any woman with a normal
VOL. 106 NO. 5 / OCTOBER 2016 e3

Downloaded for Anonymous User (n/a) at University of Alabama at Birmingham NAAL from ClinicalKey.com by Elsevier on April 17, 2017.
For personal use only. No other uses without permission. Copyright ©2017. Elsevier Inc. All rights reserved.
ASRM PAGES 141
uterus, regardless of age and even in the absence of ovaries are not prohibited from reproduction because of their short-
and ovarian function. A woman's reproductive lifespan, ened life expectancy. Given the possibility that postmeno-
once a dictate of nature, now can be artificially extended pausal reproduction may satisfy the strong desire of a
using hormone therapy and oocyte or embryo donation, or couple or individual for offspring, it would be wrong to
in other cases using autologous cryopreserved eggs or deny women the use of donated oocytes or embryos solely
embryos procured from earlier treatment cycles. In the because of their age.
United States nearly 20,000 embryo transfers using either
fresh or frozen donated eggs or embryos occur annually, ARGUMENTS AGAINST OOCYTE AND
and often to women of ARA. EMBRYO DONATION TO WOMEN OF
Oocyte donation to younger women with primary ovarian
ADVANCED REPRODUCTIVE AGE
insufficiency, gonadal dysgenesis, poor oocyte quality, or
diminished ovarian reserve falls into the conventional realm Arguments against oocyte and embryo donation to ARA
of medical treatment addressing the needs of individuals women are based on ideas about natural limits to reproduc-
suffering from pathological conditions. However, the practice tion, concerns about childrearing, longevity, and medical
of oocyte and embryo donation is more ethically challenged risks. Biologic naturalism contends that oocyte and embryo
when it is used as treatment for women who have experienced donation to older women breaches the ‘‘natural’’ limit to
natural menopause. The average age of spontaneous meno- reproductive capacity in humans and that limited reproduc-
pause in the United States is about 52 years, an age at which tive abilities defined by aging is intrinsic to being human.
most women neither desire nor expect to have children. None- Thus, to transcend this limit is ‘‘unnatural.’’ According to
theless, circumstances may lead some women beyond the nat- this view, the fact that some grandparents successfully raise
ural age of menopause to request oocyte or embryo donation. children would not necessarily be sufficient to justify using
For example, women with no children may find life partners assisted reproductive technologies to establish pregnancies
in their 50s and desire to start a family, or older couples in sec- after menopause.
ond marriages may wish to have children together. In other Another concern relates to the belief that ARA women
cases, the loss of a child may motivate couples to seek fertility and their partners may be unable to meet the emotional,
care. Women may wish to transfer cryopreserved embryos financial, and physical demands of raising a child and main-
from a prior in vitro fertilization (IVF) cycle performed years taining a long-term parental relationship. In addition, there is
before menopause occurred. Is the use of a technology that a greater likelihood with older parents that the children will
extends women's reproductive life beyond the age of natural suffer the loss of one or both parents before reaching adult-
menopause so unreasonable as to be denied, and, if not, hood (6). Data on obstetrical and neonatal outcomes associ-
should a recommended standard of practice for its application ated with pregnancy after age 50 remain preliminary and
be defined? concerns have been raised that the risks to mother and child
are too great to justify the provision of oocytes or embryos
to ARA women. Opponents to providing oocytes or embryos
ARGUMENTS IN FAVOR OF OOCYTE AND to women in their 50s and older argue that pregnancy at
EMBRYO DONATION TO WOMEN OF this age serves neither the interests of older women, nor the
ADVANCED REPRODUCTIVE AGE interests of the children they bear.
Arguments in favor of oocyte and embryo donation to ARA
women are based on medical efficacy and safety, societal MEDICAL AND OBSTETRICAL ISSUES
practices, gender equality, and reproductive freedom. Live- The medical and obstetrical risks associated with oocyte or
birth rates per embryo transfer in women undergoing egg embryo donation to women following natural menopause
and embryo donation are generally above 50% (5). Practices are still largely preliminary because of the limited amount
throughout the United States offering assisted reproduction of published data. It is well established that medical and
typically provide donor oocytes and embryos, making ser- obstetrical complications are significantly increased in preg-
vices readily accessible. In our society, it is not unusual for nant women over the age of 45 years, especially regarding
children to be raised by grandparents who take on most of adverse events occurring as a result of hypertensive disorders
the parenting role and often bring economic stability, and diabetes (7, 8). One report on the US experience with
parental responsibility, and maturity to the family unit. donor oocyte cycles from 1996–98 included 440 cycles with
There is, therefore, no reason to assume that society will be recipients aged 50–54 (9) but did not assess maternal
harmed by allowing ARA individuals to procreate, or that complications of pregnancy. High rates of pregnancy-
older women and their partners lack the physical and psy- induced hypertension, gestational diabetes, and cesarean sec-
chological stamina for raising children. Also, older men tions in recipients over 50 years old have also been noted (2,
may naturally father children and are not restricted from as- 10–13). In one series of 45 live births delivered by healthy
sisted reproductive care when seeking fertility services. women aged 50–63 who established pregnancy with
Therefore denying ARA women a successful alternative for donated oocytes, 35% experienced pregnancy-induced hy-
reproduction at ages equivalent to men appears prejudicial. pertension, 20% developed gestational diabetes, and 78% un-
Finally, our society respects the rights of individuals to derwent a cesarean section (11). The risks were even higher in
make reproductive choices regardless of age or life expec- women more than 55 years old, compared with those 50–
tancy. For example, individuals with life-limiting illnesses 54 years old. For example, the risk of pregnancy-induced
e4 VOL. 106 NO. 5 / OCTOBER 2016

142
hypertension was 26% in the 50–54 age group, but increased PARENTING ISSUES
to 60% in patients over 55 years of age. Only case reports Any serious discussion of the ethics of pregnancy at ARA
describe the outcome of pregnancies in women over age must focus on considerations of parenting and child support,
60 years (3). Multiple gestations increase obstetrical and especially in couples where there is only one parent or when
neonatal risk at all ages, and it is particularly important to both partners are older. Concerns include the possibility that
avoid in ARA women. In a report of obstetrical outcomes in one or both parents could die before the child reaches adult-
recipients 45 years and older, it was suggested that the high hood, the stresses of parenting as an older parent, and the dif-
rate of multiple pregnancies (39.2%) was a large contributing ficulties of meeting the emotional and physical demands of
factor to the high rate of antenatal complications (14). parenting.
Accordingly, increased use of multifetal pregnancy reduction Parental loss is one of the most stressful life events for
procedures has occurred in women over age 45 (15). children or adolescents to endure (27). Although a 50-year-
The effect on the offspring of ARA mothers conceiving old Caucasian woman in the United States has a life expec-
through oocyte and embryo donation is even less clear and tancy of over 80 years, on average, it is more likely that a
under-reported. Some studies suggest a higher risk of low woman who conceives at 50 rather than at 30 will die before
birth weight and fetal mortality in women over 50 years old her child reaches adulthood. The age and health of the partner
(16) while others show risks to be similar to those of younger and his or her life expectancy should therefore be discussed
women undergoing oocyte donation (17, 18). when considering oocyte and embryo donation procedures.
In general, the incidence of genetic abnormalities in the Under these circumstances, many of the children born from
offspring of women undergoing oocyte and embryo donation oocyte and embryo donation may not have siblings or
relates to the age of the oocyte donor and not to that of the extended family to support them after losing their parents
gestating mother. However, concerns have been raised that and may feel both physically and emotionally abandoned.
children conceived in this manner may face uncertain genetic Very few studies have been published about parenting in
risks when the male partner is older in age. Defining advanced women who conceived and delivered after natural meno-
paternal age is complicated and no clear agreement exists as pause. The limited data, however, do not support concerns
to an age threshold for suggesting a higher risk to offspring that older parents have reduced parenting capacity. Indeed,
(19). However, although relatively rare events, advanced the greater financial and emotional stability older parents
paternal age has been associated with disabilities and often offer (28) may be an advantage to children. Mental
disorders resulting from single-gene mutations and chromo- and physical functioning scores, as well as parenting stress
somal abnormalities (20, 21), new dominant mutations in women over age 50 receiving donated eggs, were the
resulting in congenital anomalies (22), and an increased risk same as in younger women undergoing the same treatment
of autism (23) and schizophrenia (24) in offspring. Clinical (29). Certainly, further studies are needed on the subject of
data have been difficult to evaluate because maternal age parenting in the sixth decade of life and beyond before the
often increases along with that of the male partner. When psychological and social impact on children can be fully
oocytes from a young woman are donated, the impact of assessed.
paternal age on abnormalities in the offspring can be Gestational carrier arrangements have been proposed as a
inferred. Two small studies suggest that fertilization, means to bypass the obstetrical and neonatal risks associated
pregnancy, and live-birth rates, and the risks of abnormalities with pregnancy in ARA patients. These proposals should also
of the offspring when the male partner is over age 50, are be evaluated carefully. If ARA women have underlying med-
identical to those with younger male partners when donor oo- ical disorders that render gestating a pregnancy too risky,
cytes are provided (25, 26). then they also are more likely to have significant physical im-
Potential medical consequences may be minimized by pairments or die before their children reach adulthood.
treating only healthy ARA women and following the standard
of practice of using eSET in order to eliminate multiple-birth
gestations. It is recognized that focusing on women over the ADDITIONAL CONSIDERATIONS AND
age of natural menopause is rather arbitrary, but age- SUMMATION
related medical complications of pregnancy likely follow a A central ethical issue is whether the interests of women and
continuum of increasing risk. As for other assisted reproduc- children are well served by the use of ART technology in this
tive technology (ART) candidates for whom pregnancy poses manner. These interests may be realized when the desire
particular and elevated risks to health, providers are obligated for a child and the ultimate bearing and rearing of a
to thoroughly and systematically evaluate the magnitude of child contribute to mutual well-being. The Committee
risks to the patient in pregnancy and beyond and to counsel believes that many ARA women, particularly in the age range
patients about these concerns. Inclusion of a physician expe- of 45–54, are healthy and well prepared for parenting, and
rienced in the care of high-risk obstetrical patients in the pro- therefore are reasonable candidates to receive donated oo-
cesses of preconception evaluation and counseling is the best cytes and embryos.
means to assure that these objectives are met. It is ethically Infertility is an expected characteristic of menopause. The
permissible for physicians to decline to provide treatment to Committee believes that achieving a pregnancy through
ARA women who have underlying medical or psychosocial oocyte and embryo donation after the occurrence of natural
conditions that may likely increase obstetrical, neonatal, menopause is not such a significant departure from other
and child-rearing risks. currently accepted fertility treatments as to be considered

ASRM PAGES 143
ethically inappropriate. However, physicians may not agree Barbara Koenig, Ph.D.; Andrew La Barbera, Ph.D., H.C.L.D.;
with extending fertility care to ARA women due to the Laurence McCullough, Ph.D.; Richard Reindollar, M.D.;
high-risk nature of pregnancy and uncertainties of childrear- Mark Sauer, M.D.; Rebecca Sokol, M.D., M.P.H.; Sean Tipton,
ing, and the Committee respects the right of practices not to M.A.; Lynn Westphal, M.D.
offer care and to refer such requests elsewhere.
The medical risks to the mother and child are of para-
REFERENCES
mount concern, but it will be many years before adequate
data are available to objectively evaluate these issues fully. 1. Sauer MV, Paulson RJ, Lobo RA. Pregnancy after 50: application of oocyte
donation to women after natural menopause. Lancet 1993;341:321–3.
Although the data on pregnancy outcome in older mothers
2. Kort DH, Gosselin J, Choi JM, Thornton MH, Cleary-Goldman J, Sauer MV.
and couples remain scant, the risks of gestational diabetes Pregnancy after age 50: defining risks for mother and child. Am J Perinatol
and pregnancy-induced hypertension in otherwise healthy 2012;29:245–50.
women are significantly higher as the age of mothers in- 3. Paulson RJ, Thornton MH, Francis MM, Salvador HS. Successful pregnancy in
creases and are particularly high after age 55. In most cases, a 63-year-old woman. Fertil Steril 1997;67:949–51.
however, these pregnancy-related complications are not se- 4. Antinori S, Gholami GH, Versaci C, Cerusico F, Dani L, Antinori M, et al. Ob-
stetric and prenatal outcome in menopausal women: a 12-year clinical
vere enough to compromise the long-term health of women
study. Reprod Biomed Online 2003;6:257–61.
and their ability to care for children. A careful medical eval- 5. Yeh JS, Steward RG, Dude AM, Shah AA, Goldfarb JM, Muasher SJ. Preg-
uation and age-appropriate health screenings should be per- nancy rates in donor oocyte cycles compared to similar autologous in vitro
formed before proceeding to treatment. Oocyte and embryo fertilization cycles: an analysis of 26,457 fresh cycles from the Society for As-
donation should be strongly discouraged if ARA patients sisted Reproductive Technology. Fertil Steril 2014;102:399–404.
have underlying medical problems that will further increase 6. Zweifel JE. Donor conception from the viewpoint of the child: positives, neg-
their obstetrical or neonatal risks. Prospective parents should atives, and promoting the welfare of the child. Fertil Steril 2015;104:513–9.
7. Grotegut CA, Chisholm CA, Johnson LN, Brown HL, Heine RP, James AH.
be counseled to expect greater risks for obstetrical complica-
Medical and obstetric complications among pregnant women aged 45
tions. Substantial caution should be exercised when consid- and older. PLoS One 2014;9:e96237.
ering these procedures, even in healthy older women, since 8. Sauer MV. Reproduction at an advanced maternal age and maternal health.
many of these medical problems are uniquely gestational. Fertil Steril 2015;103:1136–43.
Because obstetrical and neonatal risks may be directly related 9. Toner JP, Grainger DA, Frazier LM. Clinical outcomes among recipients of
to or increased by the occurrence of multiple gestations, eSET donated eggs: an analysis of the U.S. national experience, 1996-1998. Fertil
is recommended in all ARA patients. Steril 2002;78:1038–45.
10. Dulitski M, Soriano D, Schiff E, Chetrit A, Mashiach S, Seidman DS. Effect of
Finally, psychosocial counseling of ARA couples consid-
very advanced maternal age on pregnancy outcome and rate of cesarean
ering oocyte and embryo donation should include discussions delivery. Obstet Gynecol 1998;92:935–9.
of short- and long-term parenting and childrearing. The 11. Paulson RJ, Boostanfar R, Saadat P, Mor E, Tourgeman DE, Slater CC, et al.
health and age of the partner, if present, should be considered Pregnancy in the sixth decade of life: obstetric outcomes in women of
in these discussions. It is also ethically permissible for pro- advanced reproductive age. JAMA 2002;288:2320–3.
grams to decline to provide treatment to ARA women based 12. Vincent-Rohfritsch A, Le Ray C, Anselem O, Cabrol D, Goffinet F. Pregnancy
in women aged 43 years or older: maternal and perinatal risks. J Gynecol Ob-
on these concerns (30).
stet Biol Reprod (Paris) 2012;41:468–75.
13. Le Ray C, Scherier S, Anselem O, Marszalek A, Tsatsaris V, Cabrol D, et al.
Acknowledgments: This report was developed by the Ethics Association between oocyte donation and maternal and perinatal outcomes
Committee of the American Society for Reproductive Medi- in women aged 43 years or older. Hum Reprod 2012;27:896–901.
cine as a service to its members and other practicing clini- 14. Sauer MV, Paulson RJ, Lobo RA. Oocyte donation to women of advanced
cians. While this document reflects the views of members of reproductive age: pregnancy results and obstetrical outcomes in patients
that Committee, it is not intended to be the only approved 45 years and older. Hum Reprod 1996;11:2540–3.
15. Evans MI, Hume RF Jr, Polak S, Yaron Y, Drugan A, Diamond MP, et al. The
standard of practice or to dictate an exclusive course of treat-
geriatric gravida: multifetal pregnancy reduction, donor eggs, and aggres-
ment in all cases. This report was approved by the Ethics Com- sive infertility treatments. Am J Obstet Gynecol 1997;177:875–8.
mittee of the American Society for Reproductive Medicine 16. Salihu HM, Shumpert MN, Slay M, Kirby RS, Alexander GR. Childbearing
and the Board of Directors of the American Society for Repro- beyond maternal age 50 and fetal outcomes in the United States. Obstet Gy-
ductive Medicine. necol 2003;102:1006–14.
This document was reviewed by ASRM members and their 17. Sheffer-Mimouni G, Mashiach S, Dor J, Levran D, Seidman DS. Factors
input was considered in the preparation of the final docu- influencing the obstetric and perinatal outcome after oocyte donation.
Hum Reprod 2002;17:2636–40.
ment. The following members of the ASRM Ethics Committee
18. Abdalla HI, Billet A, Kan AK, Baig S, Wren M, Korea L, et al. Obstetrical
participated in the development of this document. All Com- outcome in 232 ovum donation pregnancies. Br J Obstet Gynaecol 1998;
mittee members disclosed commercial and financial relation- 105:332–7.
ships with manufacturers or distributors of goods or services 19. Ramasamy R, Chiba K, Butler P, Lamb DJ. Male biological clock: a critical
used to treat patients. Members of the Committee who were analysis of advanced paternal age. Fertil Steril 2015;103:1402–6.
found to have conflicts of interest based on the relationships 20. Fisch H, Hyun G, Golden R, Hensle TW, Olsson CA, Liberson GL. The influ-
ence of paternal age on Down syndrome. J Urol 2003;169:2275–8.
disclosed did not participate in the discussion or development
21. Lowe X, Eskenazi B, Nelson DO, Kidd S, Alme A, Wyrobek AJ. Frequency of
of this document. XY sperm increases with age in fathers of boys with Klinefelter syndrome.
Judith Daar, J.D.; Jean Benward, M.S.W.; Lee Collins, Am J Hum Genet 2001;69:1046–54.
J.D.; Joseph Davis, D.O.; Leslie Francis, Ph.D., J.D.; Elena 22. McIntosh GC, Olshan AF, Baird PA. Paternal age and the risk of birth defects
Gates, M.D.; Elizabeth Ginsburg, M.D.; Sigal Klipstein, M.D.; in offspring. Epidemiology 1995;6:282–8.

Fertility and Sterility® 144
23. Reichenberg A, Gross R, Weiser M, Bresnahan M, Silverman J, Harlap S, et al. 27. Dowdney L. Childhood bereavement following parental death. J Child Psy-
Advancing paternal age and autism. Arch Gen Psychiatry 2006;63:1026–32. chol Psychiatry 2000;41:819–30.
24. Sipos A, Rasmussen F, Harrison G, Tynelius P, Lewis G, Leon DA, et al. 28. Steiner AZ, Paulson RJ. Parenting issues among women of advanced repro-
Paternal age and schizophrenia: a population based cohort study. BMJ ductive age: Does age really matter? Fertil Steril 2006;85:S8.
2004;329:1070. 29. Steiner AZ, Paulson RJ. Motherhood after age fifty: An evaluation of
25. Gallardo E, Simon C, Levy M, Guanes PP, Remohi J, Pellicer A. Effect of age on parenting stress and physical functioning. Fertil Steril 2007;87:1327–32.
sperm fertility potential: oocyte donation as a model. Fertil Steril 1996;66:260–4. 30. Ethics Committee of the American Society for Reproductive Medicine. Child-
26. Paulson RJ, Milligan RC, Sokol RZ. The lack of influence of age on male rearing ability and the provision of fertility services. Fertil Steril 2009;92:
fertility. Am J Obstet Gynecol 2001;184:818–22. 864–7.

ASRM PAGES 145
Oocyte or embryo donation to women
of advanced reproductive age:
an Ethics Committee opinion
Ethics Committee of the American Society for Reproductive Medicine
Advanced reproductive age (ARA) is a risk factor for female infertility, pregnancy loss, fetal anomalies, stillbirth, and obstetric com-
plications. Oocyte donation reverses the age-related decline in implantation and birth rates of women in their 40s and 50s and restores
pregnancy potential beyond menopause. However, obstetrical complications in older patients remain high, particularly related to oper-
ative delivery and hypertensive and cardiovascular risks. Physicians should perform a thorough medical evaluation designed to assess
the physical fitness of a patient for pregnancy before deciding to attempt transfer of embryos to any woman of advanced reproductive
age (>45 years). Embryo transfer should be strongly discouraged or denied to women of ARA with underlying conditions that increase
or exacerbate obstetrical risks. Because of concerns related to the high-risk nature of pregnancy, as well as longevity, treatment of
women over the age of 55 should generally be discouraged. This statement replaces the earlier ASRM Ethics Committee document
of the same name, last published in 2013 (Fertil Steril 2013;100:337–40). (Fertil SterilÒ 2016;106:e3–7. Ó2016 by American Society
for Reproductive Medicine.)
Key Words: Ethics, third-party reproduction, complications, pregnancy, parenting
Discuss: You can discuss this article with its authors and with other ASRM members at https://www.fertstertdialog.com/users/
16110-fertility-and-sterility/posts/10968-oocyte-or-embryo-donation-to-women-of-advanced-reproductive-age-an-ethics-
committee-opinion
KEY POINTS Prospective ARA patients should be embryos to women over 55 years of
counseled about the increased medi- age, even when they have no under-
Oocyte and embryo donation is an cal risks related to pregnancy, and lying medical problems, should be
established standard of practice for that many of these risks are poorly discouraged.
the treatment of age-related infer- characterized due to lack of data. Multiple pregnancy significantly in-
tility and is associated with high The counseling process should creases the risks associated with
rates of pregnancy success. involve the participation of a physi- pregnancy and delivery; therefore,
Adverse obstetrical events and out- cian familiar with managing high- elective single embryo transfer
comes are associated with advanced risk pregnancy. (eSET) is the preferred method of
reproductive age (ARA), particularly Oocyte and embryo donation should treatment in ARA women.
related to operative delivery, hyper- be strongly discouraged if underly- Prospective older parents should be
tensive disorders, gestational dia- ing medical conditions that could counseled regarding short- and
betes, and perinatal mortality. further increase the obstetrical and long-term parenting and child-
Women of ARA considering oocyte neonatal risks are present, particu- rearing issues specific to their age.
or embryo donation should undergo larly hypertension or diabetes. The age and health of the partner, if
comprehensive medical testing In view of the limited data regarding present, should also be considered
focused on ascertaining cardiovas- maternal and fetal safety, as well as in this discussion.
cular and metabolic fitness, as well concerns related to longevity and It is ethically permissible for pro-
as a psychosocial evaluation to the need for adequate psychosocial grams to decline to provide treat-
determine if adequate supports are supports for raising a child to adult- ment to women of ARA based on
in place to raise a child to adulthood. hood, providing donor oocytes or concerns over the health and well-
being of the patient and offspring.
Received July 1, 2016; accepted July 1, 2016; published online July 20, 2016. The reported success of oocyte
Reprint requests: Ethics Committee, American Society for Reproductive Medicine, 1209 Montgomery
Hwy, Birmingham, Alabama 35216 (E-mail: [email protected]). donation to women in their 50s (1, 2)
and early 60s (3, 4) suggests that
Fertility and Sterility® Vol. 106, No. 5, October 2016 0015-0282/$36.00 pregnancy may be possible in
http://dx.doi.org/10.1016/j.fertnstert.2016.07.002 virtually any woman with a normal

ASRM PAGES 146
uterus, regardless of age and even in the absence of ovaries are not prohibited from reproduction because of their short-
and ovarian function. A woman's reproductive lifespan, ened life expectancy. Given the possibility that postmeno-
once a dictate of nature, now can be artificially extended pausal reproduction may satisfy the strong desire of a
using hormone therapy and oocyte or embryo donation, or couple or individual for offspring, it would be wrong to
in other cases using autologous cryopreserved eggs or deny women the use of donated oocytes or embryos solely
embryos procured from earlier treatment cycles. In the because of their age.
United States nearly 20,000 embryo transfers using either
fresh or frozen donated eggs or embryos occur annually, ARGUMENTS AGAINST OOCYTE AND
and often to women of ARA. EMBRYO DONATION TO WOMEN OF
Oocyte donation to younger women with primary ovarian
ADVANCED REPRODUCTIVE AGE
insufficiency, gonadal dysgenesis, poor oocyte quality, or
diminished ovarian reserve falls into the conventional realm Arguments against oocyte and embryo donation to ARA
of medical treatment addressing the needs of individuals women are based on ideas about natural limits to reproduc-
suffering from pathological conditions. However, the practice tion, concerns about childrearing, longevity, and medical
of oocyte and embryo donation is more ethically challenged risks. Biologic naturalism contends that oocyte and embryo
when it is used as treatment for women who have experienced donation to older women breaches the ‘‘natural’’ limit to
natural menopause. The average age of spontaneous meno- reproductive capacity in humans and that limited reproduc-
pause in the United States is about 52 years, an age at which tive abilities defined by aging is intrinsic to being human.
most women neither desire nor expect to have children. None- Thus, to transcend this limit is ‘‘unnatural.’’ According to
theless, circumstances may lead some women beyond the nat- this view, the fact that some grandparents successfully raise
ural age of menopause to request oocyte or embryo donation. children would not necessarily be sufficient to justify using
For example, women with no children may find life partners assisted reproductive technologies to establish pregnancies
in their 50s and desire to start a family, or older couples in sec- after menopause.
ond marriages may wish to have children together. In other Another concern relates to the belief that ARA women
cases, the loss of a child may motivate couples to seek fertility and their partners may be unable to meet the emotional,
care. Women may wish to transfer cryopreserved embryos financial, and physical demands of raising a child and main-
from a prior in vitro fertilization (IVF) cycle performed years taining a long-term parental relationship. In addition, there is
before menopause occurred. Is the use of a technology that a greater likelihood with older parents that the children will
extends women's reproductive life beyond the age of natural suffer the loss of one or both parents before reaching adult-
menopause so unreasonable as to be denied, and, if not, hood (6). Data on obstetrical and neonatal outcomes associ-
should a recommended standard of practice for its application ated with pregnancy after age 50 remain preliminary and
be defined? concerns have been raised that the risks to mother and child
are too great to justify the provision of oocytes or embryos
to ARA women. Opponents to providing oocytes or embryos
ARGUMENTS IN FAVOR OF OOCYTE AND to women in their 50s and older argue that pregnancy at
EMBRYO DONATION TO WOMEN OF this age serves neither the interests of older women, nor the
ADVANCED REPRODUCTIVE AGE interests of the children they bear.
Arguments in favor of oocyte and embryo donation to ARA
women are based on medical efficacy and safety, societal MEDICAL AND OBSTETRICAL ISSUES
practices, gender equality, and reproductive freedom. Live- The medical and obstetrical risks associated with oocyte or
birth rates per embryo transfer in women undergoing egg embryo donation to women following natural menopause
and embryo donation are generally above 50% (5). Practices are still largely preliminary because of the limited amount
throughout the United States offering assisted reproduction of published data. It is well established that medical and
typically provide donor oocytes and embryos, making ser- obstetrical complications are significantly increased in preg-
vices readily accessible. In our society, it is not unusual for nant women over the age of 45 years, especially regarding
children to be raised by grandparents who take on most of adverse events occurring as a result of hypertensive disorders
the parenting role and often bring economic stability, and diabetes (7, 8). One report on the US experience with
parental responsibility, and maturity to the family unit. donor oocyte cycles from 1996–98 included 440 cycles with
There is, therefore, no reason to assume that society will be recipients aged 50–54 (9) but did not assess maternal
harmed by allowing ARA individuals to procreate, or that complications of pregnancy. High rates of pregnancy-
older women and their partners lack the physical and psy- induced hypertension, gestational diabetes, and cesarean sec-
chological stamina for raising children. Also, older men tions in recipients over 50 years old have also been noted (2,
may naturally father children and are not restricted from as- 10–13). In one series of 45 live births delivered by healthy
sisted reproductive care when seeking fertility services. women aged 50–63 who established pregnancy with
Therefore denying ARA women a successful alternative for donated oocytes, 35% experienced pregnancy-induced hy-
reproduction at ages equivalent to men appears prejudicial. pertension, 20% developed gestational diabetes, and 78% un-
Finally, our society respects the rights of individuals to derwent a cesarean section (11). The risks were even higher in
make reproductive choices regardless of age or life expec- women more than 55 years old, compared with those 50–
tancy. For example, individuals with life-limiting illnesses 54 years old. For example, the risk of pregnancy-induced

147
hypertension was 26% in the 50–54 age group, but increased PARENTING ISSUES
to 60% in patients over 55 years of age. Only case reports Any serious discussion of the ethics of pregnancy at ARA
describe the outcome of pregnancies in women over age must focus on considerations of parenting and child support,
60 years (3). Multiple gestations increase obstetrical and especially in couples where there is only one parent or when
neonatal risk at all ages, and it is particularly important to both partners are older. Concerns include the possibility that
avoid in ARA women. In a report of obstetrical outcomes in one or both parents could die before the child reaches adult-
recipients 45 years and older, it was suggested that the high hood, the stresses of parenting as an older parent, and the dif-
rate of multiple pregnancies (39.2%) was a large contributing ficulties of meeting the emotional and physical demands of
factor to the high rate of antenatal complications (14). parenting.
Accordingly, increased use of multifetal pregnancy reduction Parental loss is one of the most stressful life events for
procedures has occurred in women over age 45 (15). children or adolescents to endure (27). Although a 50-year-
The effect on the offspring of ARA mothers conceiving old Caucasian woman in the United States has a life expec-
through oocyte and embryo donation is even less clear and tancy of over 80 years, on average, it is more likely that a
under-reported. Some studies suggest a higher risk of low woman who conceives at 50 rather than at 30 will die before
birth weight and fetal mortality in women over 50 years old her child reaches adulthood. The age and health of the partner
(16) while others show risks to be similar to those of younger and his or her life expectancy should therefore be discussed
women undergoing oocyte donation (17, 18). when considering oocyte and embryo donation procedures.
In general, the incidence of genetic abnormalities in the Under these circumstances, many of the children born from
offspring of women undergoing oocyte and embryo donation oocyte and embryo donation may not have siblings or
relates to the age of the oocyte donor and not to that of the extended family to support them after losing their parents
gestating mother. However, concerns have been raised that and may feel both physically and emotionally abandoned.
children conceived in this manner may face uncertain genetic Very few studies have been published about parenting in
risks when the male partner is older in age. Defining advanced women who conceived and delivered after natural meno-
paternal age is complicated and no clear agreement exists as pause. The limited data, however, do not support concerns
to an age threshold for suggesting a higher risk to offspring that older parents have reduced parenting capacity. Indeed,
(19). However, although relatively rare events, advanced the greater financial and emotional stability older parents
paternal age has been associated with disabilities and often offer (28) may be an advantage to children. Mental
disorders resulting from single-gene mutations and chromo- and physical functioning scores, as well as parenting stress
somal abnormalities (20, 21), new dominant mutations in women over age 50 receiving donated eggs, were the
resulting in congenital anomalies (22), and an increased risk same as in younger women undergoing the same treatment
of autism (23) and schizophrenia (24) in offspring. Clinical (29). Certainly, further studies are needed on the subject of
data have been difficult to evaluate because maternal age parenting in the sixth decade of life and beyond before the
often increases along with that of the male partner. When psychological and social impact on children can be fully
oocytes from a young woman are donated, the impact of assessed.
paternal age on abnormalities in the offspring can be Gestational carrier arrangements have been proposed as a
inferred. Two small studies suggest that fertilization, means to bypass the obstetrical and neonatal risks associated
pregnancy, and live-birth rates, and the risks of abnormalities with pregnancy in ARA patients. These proposals should also
of the offspring when the male partner is over age 50, are be evaluated carefully. If ARA women have underlying med-
identical to those with younger male partners when donor oo- ical disorders that render gestating a pregnancy too risky,
cytes are provided (25, 26). then they also are more likely to have significant physical im-
Potential medical consequences may be minimized by pairments or die before their children reach adulthood.
treating only healthy ARA women and following the standard
of practice of using eSET in order to eliminate multiple-birth
gestations. It is recognized that focusing on women over the ADDITIONAL CONSIDERATIONS AND
age of natural menopause is rather arbitrary, but age- SUMMATION
related medical complications of pregnancy likely follow a A central ethical issue is whether the interests of women and
continuum of increasing risk. As for other assisted reproduc- children are well served by the use of ART technology in this
tive technology (ART) candidates for whom pregnancy poses manner. These interests may be realized when the desire
particular and elevated risks to health, providers are obligated for a child and the ultimate bearing and rearing of a
to thoroughly and systematically evaluate the magnitude of child contribute to mutual well-being. The Committee
risks to the patient in pregnancy and beyond and to counsel believes that many ARA women, particularly in the age range
patients about these concerns. Inclusion of a physician expe- of 45–54, are healthy and well prepared for parenting, and
rienced in the care of high-risk obstetrical patients in the pro- therefore are reasonable candidates to receive donated oo-
cesses of preconception evaluation and counseling is the best cytes and embryos.
means to assure that these objectives are met. It is ethically Infertility is an expected characteristic of menopause. The
permissible for physicians to decline to provide treatment to Committee believes that achieving a pregnancy through
ARA women who have underlying medical or psychosocial oocyte and embryo donation after the occurrence of natural
conditions that may likely increase obstetrical, neonatal, menopause is not such a significant departure from other
and child-rearing risks. currently accepted fertility treatments as to be considered

ASRM PAGES 148
ethically inappropriate. However, physicians may not agree Barbara Koenig, Ph.D.; Andrew La Barbera, Ph.D., H.C.L.D.;
with extending fertility care to ARA women due to the Laurence McCullough, Ph.D.; Richard Reindollar, M.D.;
high-risk nature of pregnancy and uncertainties of childrear- Mark Sauer, M.D.; Rebecca Sokol, M.D., M.P.H.; Sean Tipton,
ing, and the Committee respects the right of practices not to M.A.; Lynn Westphal, M.D.
offer care and to refer such requests elsewhere.
The medical risks to the mother and child are of para-
REFERENCES
mount concern, but it will be many years before adequate
data are available to objectively evaluate these issues fully. 1. Sauer MV, Paulson RJ, Lobo RA. Pregnancy after 50: application of oocyte
donation to women after natural menopause. Lancet 1993;341:321–3.
Although the data on pregnancy outcome in older mothers
2. Kort DH, Gosselin J, Choi JM, Thornton MH, Cleary-Goldman J, Sauer MV.
and couples remain scant, the risks of gestational diabetes Pregnancy after age 50: defining risks for mother and child. Am J Perinatol
and pregnancy-induced hypertension in otherwise healthy 2012;29:245–50.
women are significantly higher as the age of mothers in- 3. Paulson RJ, Thornton MH, Francis MM, Salvador HS. Successful pregnancy in
creases and are particularly high after age 55. In most cases, a 63-year-old woman. Fertil Steril 1997;67:949–51.
however, these pregnancy-related complications are not se- 4. Antinori S, Gholami GH, Versaci C, Cerusico F, Dani L, Antinori M, et al. Ob-
stetric and prenatal outcome in menopausal women: a 12-year clinical
vere enough to compromise the long-term health of women
study. Reprod Biomed Online 2003;6:257–61.
and their ability to care for children. A careful medical eval- 5. Yeh JS, Steward RG, Dude AM, Shah AA, Goldfarb JM, Muasher SJ. Preg-
uation and age-appropriate health screenings should be per- nancy rates in donor oocyte cycles compared to similar autologous in vitro
formed before proceeding to treatment. Oocyte and embryo fertilization cycles: an analysis of 26,457 fresh cycles from the Society for As-
donation should be strongly discouraged if ARA patients sisted Reproductive Technology. Fertil Steril 2014;102:399–404.
have underlying medical problems that will further increase 6. Zweifel JE. Donor conception from the viewpoint of the child: positives, neg-
their obstetrical or neonatal risks. Prospective parents should atives, and promoting the welfare of the child. Fertil Steril 2015;104:513–9.
7. Grotegut CA, Chisholm CA, Johnson LN, Brown HL, Heine RP, James AH.
be counseled to expect greater risks for obstetrical complica-
Medical and obstetric complications among pregnant women aged 45
tions. Substantial caution should be exercised when consid- and older. PLoS One 2014;9:e96237.
ering these procedures, even in healthy older women, since 8. Sauer MV. Reproduction at an advanced maternal age and maternal health.
many of these medical problems are uniquely gestational. Fertil Steril 2015;103:1136–43.
Because obstetrical and neonatal risks may be directly related 9. Toner JP, Grainger DA, Frazier LM. Clinical outcomes among recipients of
to or increased by the occurrence of multiple gestations, eSET donated eggs: an analysis of the U.S. national experience, 1996-1998. Fertil
is recommended in all ARA patients. Steril 2002;78:1038–45.
10. Dulitski M, Soriano D, Schiff E, Chetrit A, Mashiach S, Seidman DS. Effect of
Finally, psychosocial counseling of ARA couples consid-
very advanced maternal age on pregnancy outcome and rate of cesarean
ering oocyte and embryo donation should include discussions delivery. Obstet Gynecol 1998;92:935–9.
of short- and long-term parenting and childrearing. The 11. Paulson RJ, Boostanfar R, Saadat P, Mor E, Tourgeman DE, Slater CC, et al.
health and age of the partner, if present, should be considered Pregnancy in the sixth decade of life: obstetric outcomes in women of
in these discussions. It is also ethically permissible for pro- advanced reproductive age. JAMA 2002;288:2320–3.
grams to decline to provide treatment to ARA women based 12. Vincent-Rohfritsch A, Le Ray C, Anselem O, Cabrol D, Goffinet F. Pregnancy
in women aged 43 years or older: maternal and perinatal risks. J Gynecol Ob-
on these concerns (30).
stet Biol Reprod (Paris) 2012;41:468–75.
13. Le Ray C, Scherier S, Anselem O, Marszalek A, Tsatsaris V, Cabrol D, et al.
Acknowledgments: This report was developed by the Ethics Association between oocyte donation and maternal and perinatal outcomes
Committee of the American Society for Reproductive Medi- in women aged 43 years or older. Hum Reprod 2012;27:896–901.
cine as a service to its members and other practicing clini- 14. Sauer MV, Paulson RJ, Lobo RA. Oocyte donation to women of advanced
cians. While this document reflects the views of members of reproductive age: pregnancy results and obstetrical outcomes in patients
that Committee, it is not intended to be the only approved 45 years and older. Hum Reprod 1996;11:2540–3.
15. Evans MI, Hume RF Jr, Polak S, Yaron Y, Drugan A, Diamond MP, et al. The
standard of practice or to dictate an exclusive course of treat-
geriatric gravida: multifetal pregnancy reduction, donor eggs, and aggres-
ment in all cases. This report was approved by the Ethics Com- sive infertility treatments. Am J Obstet Gynecol 1997;177:875–8.
mittee of the American Society for Reproductive Medicine 16. Salihu HM, Shumpert MN, Slay M, Kirby RS, Alexander GR. Childbearing
and the Board of Directors of the American Society for Repro- beyond maternal age 50 and fetal outcomes in the United States. Obstet Gy-
ductive Medicine. necol 2003;102:1006–14.
This document was reviewed by ASRM members and their 17. Sheffer-Mimouni G, Mashiach S, Dor J, Levran D, Seidman DS. Factors
input was considered in the preparation of the final docu- influencing the obstetric and perinatal outcome after oocyte donation.
Hum Reprod 2002;17:2636–40.
ment. The following members of the ASRM Ethics Committee
18. Abdalla HI, Billet A, Kan AK, Baig S, Wren M, Korea L, et al. Obstetrical
participated in the development of this document. All Com- outcome in 232 ovum donation pregnancies. Br J Obstet Gynaecol 1998;
mittee members disclosed commercial and financial relation- 105:332–7.
ships with manufacturers or distributors of goods or services 19. Ramasamy R, Chiba K, Butler P, Lamb DJ. Male biological clock: a critical
used to treat patients. Members of the Committee who were analysis of advanced paternal age. Fertil Steril 2015;103:1402–6.
found to have conflicts of interest based on the relationships 20. Fisch H, Hyun G, Golden R, Hensle TW, Olsson CA, Liberson GL. The influ-
ence of paternal age on Down syndrome. J Urol 2003;169:2275–8.
disclosed did not participate in the discussion or development
21. Lowe X, Eskenazi B, Nelson DO, Kidd S, Alme A, Wyrobek AJ. Frequency of
of this document. XY sperm increases with age in fathers of boys with Klinefelter syndrome.
Judith Daar, J.D.; Jean Benward, M.S.W.; Lee Collins, Am J Hum Genet 2001;69:1046–54.
J.D.; Joseph Davis, D.O.; Leslie Francis, Ph.D., J.D.; Elena 22. McIntosh GC, Olshan AF, Baird PA. Paternal age and the risk of birth defects
Gates, M.D.; Elizabeth Ginsburg, M.D.; Sigal Klipstein, M.D.; in offspring. Epidemiology 1995;6:282–8.

23. Reichenberg A, Gross R, Weiser M, Bresnahan M, Silverman J, Harlap S, et al. 27. Dowdney L. Childhood bereavement following parental death. J Child Psy-
Advancing paternal age and autism. Arch Gen Psychiatry 2006;63:1026–32. chol Psychiatry 2000;41:819–30.
24. Sipos A, Rasmussen F, Harrison G, Tynelius P, Lewis G, Leon DA, et al. 28. Steiner AZ, Paulson RJ. Parenting issues among women of advanced repro-
Paternal age and schizophrenia: a population based cohort study. BMJ ductive age: Does age really matter? Fertil Steril 2006;85:S8.
2004;329:1070. 29. Steiner AZ, Paulson RJ. Motherhood after age fifty: An evaluation of
25. Gallardo E, Simon C, Levy M, Guanes PP, Remohi J, Pellicer A. Effect of age on parenting stress and physical functioning. Fertil Steril 2007;87:1327–32.
sperm fertility potential: oocyte donation as a model. Fertil Steril 1996;66:260–4. 30. Ethics Committee of the American Society for Reproductive Medicine. Child-
26. Paulson RJ, Milligan RC, Sokol RZ. The lack of influence of age on male rearing ability and the provision of fertility services. Fertil Steril 2009;92:
fertility. Am J Obstet Gynecol 2001;184:818–22. 864–7.

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Financial compensation of oocyte
donors: an Ethics Committee opinion
The Ethics Committee of the American Society for Reproductive Medicine
Financial compensation of women donating oocytes for reproductive or research purposes is justified on ethical grounds and should
acknowledge the time, inconvenience, and discomfort associated with screening, ovarian stimulation, oocyte retrieval, and postre-
trieval recovery and not vary according to the planned use of the oocytes or the number or quality of oocytes retrieved. This document
replaces the document of the same name published in 2016. (Fertil SterilÒ 2021;116:319-25. Ó2021 by American Society for Repro-
ductive Medicine.)
Discuss: You can discuss this article with its authors and other readers at https://www.fertstertdialog.com/posts/32760
ESSENTIAL POINTS
Financial compensation of women donating oocytes for reproductive or research purposes is justified on ethical grounds.
Compensation is in accord with principles of fairness, occurring within the framework of a professional relationship.
Compensation should acknowledge the donor’s time, inconvenience, and discomfort associated with screening, ovarian stim-
ulation, oocyte retrieval, and postretrieval recovery. Compensation should not vary according to the planned use of the oo-
cytes (reproductive or research) or the number or quality of oocytes retrieved.
Compensation should be fair and should not be an undue enticement that negatively impacts a donor’s ability to make an
informed decision about the donation process and the risks involved with donation.
All oocyte-donor recruitment programs, including agencies, egg banks, and fertility clinics, should individually adopt and
implement effective processes for information disclosure and counseling in order to promote informed decision-making by
prospective donors.
Treating physicians owe the same professional duties to oocyte donors as to all other patients.
Programs should ensure equitable and fair provision of services to oocyte donors.
Programs should individually adopt and disclose policies regarding coverage of an oocyte-donor’s medical costs should she
experience complications associated with the oocyte retrieval process.
T
he practice of compensating to have children. Couples and individ- through their own offers of compensa-
women for undergoing ovarian uals in need of donor oocytes can pro- tion, typically accomplished through
stimulation and oocyte retrieval cure these gametes in a variety of advertising or other outreach efforts.
for the benefit of others is commonly ways. Prospective recipients can seek Most commonly, however, oocyte
referred to as oocyte or egg ‘‘donation,’’ out voluntary and often altruistic donation is arranged through recruit-
despite the mismatch between the plain donation of oocytes from friends and ment programs including agencies,
meaning of ‘‘donation’’ and the provi- relatives, although intended parents egg banks, and fertility clinics that
sion of compensation for such services. are cautioned to consider the impact facilitate the exchange of oocytes
Since its introduction in the 1980s, of intrafamilial donation on themselves from donors to recipients. In addition
oocyte donation has increasingly been and their offspring (1). In addition, cou- to procurement of oocytes for repro-
accepted as a method of assisting pro- ples and individuals may arrange ser- ductive use, oocyte donation has
spective parents without viable oocytes vices of oocyte donors directly become an important source of mate-
rial for use in research involving
Received March 24, 2021; accepted March 24, 2021; published online April 25, 2021. stem-cell therapy, regenerative medi-
Reprint requests: American Society for Reproductive Medicine, 1209 Montgomery Highway, Birmig-
ham, Albama 35216-2809 (E-mail: [email protected]). cine, and genetic-based reproductive
technologies (2–4).
Fertility and Sterility® Vol. 116, No. 2, August 2021 0015-0282/$36.00
https://doi.org/10.1016/j.fertnstert.2021.03.040
VOL. 116 NO. 2 / AUGUST 2021 319

ASRM PAGES 151
Three decades ago, when oocyte donation first became viduals and couples recruit women for oocyte donation
clinically available, sources of donor oocytes included women through advertising, often using online postings and notices
undergoing in vitro fertilization who produced more oocytes in college or other local media sources. The amount of
than could be reasonably employed for their own use (often compensation offered varies, and it may be difficult for pro-
termed ‘‘egg sharing’’), women undergoing an unrelated sur- spective donors to know exactly what the compensation
gical procedure who underwent ovarian stimulation so that would be for their donation based solely on the postings, no-
oocytes could be retrieved during surgery, and women who tices, or media sources. One study indicated that disclosure of
agreed to undergo ovarian stimulation and oocyte retrieval fee schedules varied depending on whether the recruiter was
specifically to provide oocytes to others. Today, the source an agency or an infertility clinic (10). At least one state has
of donor oocytes has shifted away from the first two groups enacted legislation requiring all advertising for egg donation
toward oocyte retrieval specifically for the purpose of dona- to include an express warning that ‘‘not all selected egg do-
tion. One reason for this shift is the clinical success of oocyte nors receive the monetary amounts or compensation adver-
and embryo cryopreservation that has led most women in the tised’’ (11). The Committee believes that oocyte donation
first group to choose to have all their oocytes frozen or fertil- advertising and remuneration representations made by any
ized and the resulting embryos stored for their own future use entity or individual recruiting donors should be accurate
(5). The evolution of the oocyte retrieval procedure from a and transparent.
more invasive laparoscopic surgery to a less invasive transva-
ginal needle aspiration introduced an acceptably safe and
attractive means for women to donate their oocytes. In the ETHICAL CONCERNS RAISED BY
face of a growing medical need for donor oocytes, financial REMUNERATION
compensation of oocyte donors in the third group has become Concerns surrounding financial compensation of oocyte do-
routine and generally accepted as ethically justified. Further- nors often focus on the welfare of women who agree to act
more, improvement in the cryopreservation of oocytes has al- as donors and on the impact of that compensation. Monetary
lowed for the development of ‘‘egg banks,’’ entities that compensation could create the possibility of undue induce-
receive and store cryopreserved oocytes for purchase by in- ment and exploitation of women participating in oocyte
tended parents (6, 7). donation. Women may agree to provide oocytes based on
The issue of financial compensation for oocyte donors their financial need. High levels of compensation also could
raises numerous ethical questions, three of which are dis- lead some prospective donors to conceal medical information
cussed in this opinion. Do recruitment practices incorporating relevant to their own health or that of their genetic offspring
remuneration sufficiently protect the health interests and in order to be more likely to be selected for oocyte donation.
safety of oocyte donors? Does financial compensation There is a possibility that women could discount the physical,
devalue human life by treating oocytes as property or com- social, and emotional risks of oocyte donation out of eager-
modities? Does prohibition of financial compensation to ness to address their personal financial interests. Financial
oocyte donors devalue the services women are uniquely posi- compensation could raise ethical issues on the grounds that
tioned to supply by creating a system of forced altruism? it conflicts with the prevailing belief that gametes should
not become products bought and sold in the marketplace. A
further ethical concern is that the commodification of gam-
THE PRACTICE OF REMUNERATION etes could translate into the devaluation of donor-conceived
In recognition of the significant time, inconvenience, and offspring who will be viewed in relation to their market value
discomfort associated with oocyte donation, remuneration rather than their intrinsic worth (12).
of donors has become a common practice. Oocyte donation Women undergoing retrieval purely to provide oocytes to
utilizing the services of paid donors is now established as a others are exposed to physical and psychological risks that
component of assisted reproductive technology (ART). In they would not otherwise face. There is some risk of uninten-
2016, approximately 9% of all ART cycles reported to the So- tional pregnancy, because hormonal contraceptives must be
ciety for Assisted Reproductive Technologies (SART) involved discontinued prior to participation. Donors also are exposed
the use of donor oocytes, including both fresh oocytes and oo- to risks of morbidity and a remote risk of mortality from
cytes that were previously frozen and thawed (8). An early sur- ovarian stimulation and oocyte retrieval (13). Although cur-
vey published in 1993 found that approximately 60% of rent data are reassuring, it is possible that fertility drugs
responding programs offered compensation to women under- and procedures involved in oocyte donation might increase
going oocyte retrieval solely to provide oocytes to others (9). In a woman’s future health risks, including the risk of impaired
2016, 88% of the 463 assisted reproduction programs report- fertility (14). Young women may be prone to dismiss the po-
ing to SART stated that they offered oocyte donation services tential psychological consequences of donation, particularly
(8). Although SART collects data on the use of donor oocytes in those that could arise if they later experience infertility prob-
ART cycles, it does not ask clinics to report on their donor- lems themselves. They may also underestimate the psycho-
compensation practices and policies. Decisions concerning logical and legal consequences of their agreement to
such policies and practices are for clinics to make individually. renounce parental rights and future contact with children
Although there is some variation in compensation ar- born to oocyte recipients. The renunciation of future contact
rangements, they have certain features in common. Egg may turn out to be illusory, however, as increasingly sophis-
donor agencies, egg banks, fertility clinics, and infertile indi- ticated genetic testing, coupled with the reach of the Internet,
320 VOL. 116 NO. 2 / AUGUST 2021

152
may enable donor-conceived offspring to contact their oocyte justified on several ethical grounds: 1) The existence of a sys-
donors long into the future, even if the donor made the deci- tem of fair recompense within the context of a professional
sion to keep the fact of her donation private. relationship shows respect for women’s autonomy and honors
Another ethical concern is that compensation for oocytes their capacity to make informed choices about their bodies
could imply that gametes are property or commodities that and economic lives. 2) Rather than regarding women and
can be bought and sold and thus could devalue their inherent their contributions as commodities, fair compensation for
linkage with human life. At the outset, it is noteworthy that oocyte donation is in line with routine reimbursement for
this critique is rarely, if ever, levied against the practice of medical services, including those in connection with repro-
sperm donation and appears uniquely in the realm of oocyte duction. 3) Providing compensation for donation may in-
donation. For some, the concern about human commodifica- crease the number of oocyte donors, which in turn, would
tion is based on the presumption that compensation to indi- allow greater options for infertile persons and provide more
viduals for reproductive and other tissues is inconsistent choice in selection of oocyte donors. 4) The provision of
with maintaining important values related to respect for hu- compensation does not necessarily discourage altruistic moti-
man life and dignity. Arguably, this view is reflected in state vations; indeed, in surveys of women receiving compensa-
and federal laws prohibiting direct compensation to individ- tion, most reported that helping childless persons remained
uals providing organs and tissues for transplantation. Yet, a significant factor in their decision to donate (16–20). In a
such laws generally permit organ and tissue donors to receive survey of donors who had been compensated by up to
reimbursement for expenses and other costs associated with $5,000, 88% of donors reported that the best thing about
the donation procedure. In the analogous circumstance of the donation experience was ‘‘being able to help someone’’
biomedical research, human subjects exposed to physical (18). 5) Financial compensation may be defended on the
and psychological risks are often reimbursed for expenses. grounds that it advances the ethical goal of fairness to
Moreover, they may receive additional compensation for donors. There is no doubt that oocyte donors bear burdens
the time and inconvenience associated with study participa- on behalf of recipients and society, and compensation for
tion. These facts support the compensation of oocyte donors bearing those burdens may be justified morally. Because the
regardless of the ultimate use of the oocytes (e.g., fertility burdens of donation are similar regardless of the ultimate
therapy or research). use of the oocytes, compensating donors of oocytes for
Compensation based on the time, inconvenience, and research is also ethically justified. There has been some
discomfort associated with oocyte retrieval can and should movement at the state level to permit compensation to
be distinguished from payment for the oocytes themselves. research donors, which stands in contrast to the approach
Such compensation is also consistent with sperm donation articulated by the National Academy of Sciences with
and with employment and other situations in which individ- respect to compensation for oocyte donation for stem-cell
uals are compensated for activities demanding time, physical research (21). In 2009, New York became the first US state
effort, and risk. to implement a policy permitting researchers to use public
Arguments that support a no-compensation policy often funds to reimburse women who donate oocytes directly and
focus on the perceived impact compensation will have on the solely for stem-cell research, not only for the woman’s out-
donors and on any offspring born of their donation. For of-pocket expenses, but also for the time, burden, and
example, some argue that as compensation to women discomfort associated with the donation process (22). A law
providing oocytes increases in amount, the ethical concerns enacted in California in 2019 likewise requires women who
will increase as well. The higher the compensation, arguably provide human oocytes for research to be compensated for
the greater the possibility that women will discount risks to their time, discomfort, and inconvenience in the same manner
themselves or be less forthcoming about their medical and so- as other research subjects, removing a previous prohibition of
cial history in order to be accepted as a donor. Higher levels of compensation of research donors (11).
compensation, particularly for women with specific charac- As an ethical matter, permitting compensation for oocyte
teristics, may also convey the idea that oocytes are commodi- donation for reproductive purposes but not research purposes
fiable. To the extent that such compensation may reflect an fails to recognize the donor’s significant contributions when
effort to promote the birth of persons with traits deemed so- donating oocytes for either of these uses. Such an approach
cially desirable, it may be seen as a form of positive eugenics. also would treat female gamete donors differently from sperm
Such efforts to enhance offspring are morally troubling to donors, who typically receive compensation (albeit a modest
some, insofar as they objectify children rather than assigning one) for a much less risky and invasive procedure. 6) The
them intrinsic dignity and worth. Finally, compensation emotional pressures created by financial incentives do not
could make donor oocytes available only to the very wealthy, necessarily exceed, and may actually be less than, those expe-
increasing social and distributive injustice related to access to rienced by women asked to make altruistic donations to rela-
fertility treatment (12, 15). tives or friends. Even if compensation were considered
unethical, there would still be a need for donor oocytes.
Such an approach would require infertile women to turn to
JUSTIFICATIONS FOR PERMITTING friends and relatives to supply the unique materials needed
REMUNERATION for their treatment, which can be demeaning and particularly
Although the potential for harm must be acknowledged and difficult for patients who already experience high levels of
addressed, financial compensation can be defended and is anxiety caused by infertility. Such an approach may also
VOL. 116 NO. 2 / AUGUST 2021 321

ASRM PAGES 153
leave potential donors more vulnerable to coercion than a providing information to allow her to assess her decision to
system in which compensation can help attract donation of donate her eggs, given the potential consequences of her
oocytes by others (23). donation and possible associated risks, and to ensure that
Although the physical and psychological risks entailed in she is not unduly influenced by financial hardships that might
oocyte donation are real, they are not so severe as to justify compel her to participate.
limiting the autonomous decision-making authority of adult Empiric data suggest that some oocyte donors may wish
women. Programs offering financial incentives should take to know whether children are born as a result of their dona-
steps to minimize the possibility of undue influence and tion. Others may have preferences about how their donated
exploitation by incorporating certain safeguards into the oocytes are used (25). For example, donors may not want their
disclosure and counseling processes. For example, agencies, oocytes to be provided to unmarried persons, same-sex cou-
egg banks, and infertility clinics should be encouraged to pro- ples, or persons of a different religion or race, or may not
vide written information to prospective donors setting out want unused embryos produced with their oocytes to be de-
their reimbursement structure and requirements for donors. stroyed or used for research. Program staff should discuss
They should also disclose any exclusion to becoming a donor, with prospective donors the amount of information they
such as age limits and medical contraindications. will be given about whether a birth occurs and any control
they will have over oocyte disposition. Women donating oo-
cytes specifically for research should be informed about po-
DISCLOSURE AND COUNSELING tential uses of their tissues. Explicit consent should be given
Prospective donors should be fully informed about the poten- when donors are providing embryos for research whose intent
tial medical and psychological risks of undergoing oocyte is to create embryos for study. In no case should research em-
retrieval for reproduction or research (10). This ethical obliga- bryos be used for reproductive purposes without prior
tion to ensure the informed consent of prospective donors at- informed consent of the donor.
taches to any party or program seeking the services of an
oocyte donor, including providers assisting intended parents, THE COMPENSATION STRUCTURE
fertility clinics, egg banks, and agencies involved in recruiting
Compensation to women providing oocytes should be fair and
or matching donors and recipients. Women donating oocytes
not used as an undue enticement that will lead prospective
for research should be afforded the additional protection of
donors to discount risks. Monetary compensation should
review by an institutional review board or other required
reflect the time, inconvenience, and physical and emotional
oversight body with authority for approval of the informed
demands associated with participating in oocyte donation.
consent process and documents.
Thus, each clinic or donor agency may decide for itself in
The potential negative health and psychological effects of
any particular case and in the exercise of its own judgment
oocyte donation should be openly acknowledged. Prospective
that a woman who withdraws from donation for medical or
donors should understand the measures they must take to
other reasons may be paid a portion of the fee proportionate
avoid unwanted pregnancy during a stimulation cycle. They
to the time and effort she contributed. To protect the donor’s
also should understand that they could later develop desires
right to withdraw, oocyte recipients must accept the risk that a
to establish contact with their genetically related children, de-
donor may change her mind at any time prior to egg retrieval.
sires that may be difficult to satisfy because of legal or other
In no circumstances should compensation be conditioned on
barriers. Alternatively, donors should be apprised that re-
successful retrieval of oocytes or the number of oocytes
maining anonymous to the recipient(s) or resulting offspring
retrieved. Likewise, donors should never be required to cover
may not be possible because of increasingly sophisticated ge-
the costs of the interrupted cycle. To avoid putting a price on
netic tracing and social-media technologies.
human oocytes, compensation should not vary according to
Donor candidates should be encouraged to explore their
the number or quality of oocytes retrieved (24).
possible emotional responses, particularly those that could
develop if they experience infertility problems themselves.
To reduce the incidence of subsequent psychological prob- ADDITIONAL ETHICAL CONSIDERATIONS
lems, it would be prudent to limit donors to women who are Once the donation process begins, oocyte donors become pa-
21 years old or older and who are more likely to possess the tients and are owed the same professional duties present in
emotional maturity to make such decisions (24). any physician–patient relationship. Programs should ensure
To enhance the likelihood that information relevant to that every donor has a physician whose primary responsibility
donation will be fully explored, programs are encouraged to is caring for her. The staff of oocyte-donor programs should
designate an individual with training and expertise in recognize that physicians providing services to both donors
mental-health care to be available to consult with prospective and recipients may encounter conflicts in promoting the
donors (24). This individual’s primary responsibilities should best interests of both parties and should create mechanisms
be to ensure that the prospective donor understands and ap- ensuring equitable and fair provision of services.
preciates the relevant information and that her consent is Programs offering oocyte donation should adopt and
freely given. She should be made aware that she may with- disclose policies regarding whether coverage exists of an
draw from the process at any point in time prior to egg oocyte-donor’s medical costs should she experience health
retrieval. The prospective donor’s motivation for participating complications from the procedure (24). Ideally, programs
should be explored during the session, with the goal of should ensure that donors are covered for any health care
322 VOL. 116 NO. 2 / AUGUST 2021

costs incurred as a result of participating. The limits and terms negatively impacts a donor’s ability to make an informed de-
of coverage need to be explained to and accepted by the cision about the donation process.
donor. Programs should also offer referral for psychological
services to donors who experience subsequent distress related Acknowledgments: This report was developed under the
to the procedure, including the experience of being excluded direction of the Ethics Committee of the American Society
from a potential donation (26). for Reproductive Medicine (ASRM) as a service to its members
All programs offering compensation for donation should and other practicing clinicians. Although it reflects appro-
ensure that advertisements for donors are accurate and priate management of a problem encountered in the practice
responsible (11). If compensation is noted in advertisements, of reproductive medicine, it is not intended to be the only
the existence of risks and burdens also should be acknowl- approved standard of practice or to dictate an exclusive
edged therein. Donors independently recruited by prospective course of treatment. Other plans of management may be
oocyte recipients, agencies, or egg banks should undergo the appropriate, taking into account the needs of the individual
same disclosure and counseling processes as donors recruited patient, available resources, and institutional or clinical prac-
by fertility practices. It is ethically permissible for a program tice limitations. The Ethics Committee and the Board of Direc-
to refuse to accept a prospective oocyte donor if they become tors of ASRM have approved this report.
aware that a prospective oocyte recipient or recruiting agency This document was reviewed by ASRM members, and
has offered gifts or payments that the program, in the exercise their input was considered in the preparation of the final
of its own ethical judgment, believes compromise the donor’s document. The following members of the ASRM Ethics Com-
free choice or are otherwise ethically inappropriate. Programs mittee participated in the development of this document: Si-
should not assume that known donors, such as family or gal Klipstein, M.D., Chair, Catherine Hammack-Aviran, M.A.,
friends, are not being financially compensated. In one study J.D., Catherine Racowsky, Ph.D., Chevis Shannon, Dr.P.H.,
of recipients using both known and anonymous donors, 19 M.P.H., M.B.A., David Shalowitz, M.D., Elizabeth Ginsburg,
of 20 of the known donors had been compensated, and there M.D., Jennifer Kawwass, M.D., Joseph Davis, D.O., Julianne
were no differences in the amounts provided to known and Zweifel, Ph.D., Katherine Cameron, M.D., Lynn Westphal,
anonymous donors (27). M.D., Mandy Katz-Jaffe, Ph.D., Mary Samplaski, M.D., Peter
To reduce the potential health risks of repeated donations Schlegel, M.D., Ricardo Azziz, M.D., M.P.H., M.B.A., Robert
and the risk of inadvertent consanguinity among offspring, Rebar, M.D., Ruth Farrell, M.D., Sean Tipton, M.A., Susan
programs may wish to limit the number of times a woman Crockin, J.D. All Committee members disclosed commercial
may undergo retrieval procedures purely to provide oocytes and financial relationships with manufacturers or distributors
to others. A good-faith effort should be made to avoid accept- of goods or services used to treat patients. Members of the
ing women who have already made a high number of dona- Committee who were found to have conflicts of interest based
tions elsewhere (24, 28). Finally, the Committee encourages on the relationships disclosed did not participate in the dis-
further study of the medical and psychological effects of cussion or development of this document.
oocyte donation on donors. Findings from such research
promise to improve understanding of risks and benefits and REFERENCES
allow programs to provide more accurate information to pro- 1. Ethics Committee of the American Society for Reproductive Medicine. Using
spective donors. family members as gamete donors or gestational carriers. Fertil Steril 2017;
107:1136–42.
2. Noggle S, Fung HL, Gore A, Martinez H, Satriani KC, Prosser R, et al. Human
oocytes reprogram somatic cells to a pluripotent state. Nature 2011;478:
CONCLUSIONS 70–7.
3. Tanaka AJ, Sauer MV, Egli D, Kort DH. Harnessing the stem cell potential:
The use of donor oocytes for reproductive and research pur-
the path to prevent mitochondrial disease. Nat Med 2013;19:1578–9.
poses is well established, resulting in family formation for 4. Ma H, Marti-Guitterez N, Park SW, Wu J, Lee Y, Suzuki K, et al. Correction of
couples and individuals who lack viable oocytes as well as a pathogenic gene mutation in human embryos. Nature 2017;548:413–9.
supporting potential advances in medical discoveries, treat- 5. Noyes N, Druckenmiller S, McCaffrey C, Labella P, Licciardi F, Grifo J. To
ments, and therapies. In the United States, it is common for freeze or not to freeze: that is the question. taking arms against the sea
women who provide oocytes for reproductive use to receive of reproductive aging through autologous oocyte cryopreservation (OC).
financial compensation. This remuneration compensates do- Fertil Steril 2017;108:e36.
6. Cobo A, Remohí J, Chang CC, Nagy ZP. Oocyte cryopreservation for donor
nors for the time, inconvenience, and discomfort associated
egg banking. Reprod Biomed Online 2011;23:341–6.
with the oocyte retrieval process and is ethically justified. 7. Kool EM, Bos AME, van der Graaf R, Fauser BCJM, Bredenoord AL. Ethics of
Compensation for donors of oocytes for research purposes is oocyte banking for third-party assisted reproduction: a systematic review.
also ethically justified. Concerns over the commodification Hum Reprod Update 2018;24:615–35.
of human gametes and its impact on human dignity are 8. Society for Assisted Reproductive Technology. 2016 Clinical summary
acknowledged; but, on balance, the need to respect women’s report. Available at: https://www.sartcorsonline.com/rptCSR_
PublicMultYear.aspx?reportingYear¼2016. Accessed March 24, 2021.
autonomy and their capacity to make informed choices com-
9. Mechanick Braverman A. Survey results on the current practice of ovum
pels support for a system of financial compensation for donation. Ovum Donor Task Force of the Psychological Special Interests
oocyte donors. Compensation should not vary according to Group of the American Fertility Society. Fertil Steril 1993;59:1216–20.
the number or quality of oocytes retrieved. Compensation 10. Holwell E, Keehn J, Leu CS, Sauer MV, Klitzman R. Egg donation brokers: an
should be fair and not become an undue enticement that analysis of agency versus IVF clinic websites. J Reprod Med 2014;59:534–41.
VOL. 116 NO. 2 / AUGUST 2021 323

ASRM PAGES 155
11. California code, health and safety code- HSC x 125325. Available at: https:// 19. Svanberg AS, Lampic C, Bergh T, Lundkvist O. Characterization of potential
codes.findlaw.com/ca/health-and-safety-code/hsc-sect-125325.html. Ac- oocyte donors in Sweden. Hum Reprod 2003;18:2205–15.
cessed March 24, 2021. 20. Pennings G, de Mouzon J, Shenfield F, Ferraretti AP, Mardesic T, Ruiz A, et al.
12. Bayefsky M, DeCherney A, Berkman B. Compensation for egg donation: a Socio-demographic and fertility-related characteristics and motivations of
zero-sum game. Fertil Steril 2016;105:1153–4. oocyte donors in eleven European countries. Hum Reprod 2014;29:
13. Levi-Setti PE, Cirillo F, Scolaro V, Morenghi E, Heilbron F, Girardello D, et al. 1076–89.
Appraisal of clinical complications after 23,827 oocyte retrievals in a large 21. Moreno JD, Hynes RO. Committee on Guidelines for Human Embryonic
assisted reproductive technology program. Fertil Steril 2018;109:1038– Stem Cell Research, National Research Council. Washington, DC: National
43.e1. Academies Press. 2005;23(7):793–794.
14. Williams CL, Jones ME, Swerdlow AJ, Botting BJ, Davies MC, Jacobs I, et al. 22. Roxland BE. New York State's landmark policies on oversight and compen-
Risks of ovarian, breast, and corpus uteri cancer in women treated with as- sation for egg donation to stem cell research. Regen Med 2012;7:397–408.
sisted reproductive technology in Great Britain, 1991–2010: data linkage 23. Kenney NJ, McGowan ML. Egg donation compensation: ethical and legal
study including 2.2 million person years of observation. Br Med J 2018; challenges. Medicoleg Bioeth 2014;2014:15–24.
362:k2644. 24. Practice Committee of the American Society for Reproductive Medicine.
15. Ethics Committee of the American Society for Reproductive Medicine. Dis- Guidance on gamete and embryo donation. Fertil Steril. In press.
parities in access to effective treatment for infertility in the United States: 25. Kalfoglou AL, Geller G. A follow-up study with oocyte donors exploring their
an Ethics Committee opinion. Fertil Steril 2015;104:1104–10. experiences, knowledge, and attitudes about the use of their oocytes and
16. Ahuja KK, Simons EG, Mostyn BJ, Bowen-Simpkins P. An assessment of the the outcome of the donation. Fertil Steril 2000;74:660–7.
motives and morals of egg share donors: policy of ‘payments’ to egg donors 26. Zweifel JE, Biaggio B, Schouweiler C, Lindheim SR. Follow-up assessment of
requires a fair review. Hum Reprod 1998;13:2671–8. excluded oocyte donor candidates. J Obstet Gynaecol Res 2009;35:320–5.
17. Ahuja KK, Mostyn BJ, Simons EG. Egg sharing and egg donation: attitudes 27. Greenfeld DA, Klock SC. Disclosure decisions among known and anony-
of British egg donors and recipients. Hum Reprod 1997;12:2845–52. mous oocyte donation recipients. Fertil Steril 2004;81:1565–71.
18. Klock SC, Stout JE, Davidson M. Psychological characteristics and factors 28. Practice Committee of the American Society for Reproductive Medicine. Re-
related to willingness to donate again among anonymous oocyte donors. petitive oocyte donation: a committee opinion. Fertil Steril 2020;113:
Fertil Steril 2003;79:1312–6. 1150–3.
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Compensacion economica en las donaciones de ovocitos: opini on del Comite de

Etica.
La compensaci on economica a las mujeres donantes de ovocitos con fines reproductivos o para investigaci on esta justificada por mo-
tivos eticos y debe reconocer el tiempo, los inconvenientes y las molestias asociadas con su cribado, la estimulaci
on ovarica, la punci
on
de ovocitos y la recuperacion posterior a la intervenci
on y no depender del uso planificado de los ovocitos o del n umero y la calidad de
los mismos. Este documento reemplaza el documento con el mismo nombre publicado en 2016.
//true copy//
VOL. 116 NO. 2 / AUGUST 2021 325

National Guidelines for Accreditation, Supervision & Regulation of
ART Clinics in India 157
Annexure P/4
Preliminary Pages
Corrigendum
Chapter 1 - Introduction, Brief history of ART and Requirement of ART Clinics
Chapter 2 - Screening of Patients for ART : Selection Criteria and Possible

Complications
Chapter 3 - Code of Practice, Ethical Considerations and Legal Issues
Chapter 4 - Sample Consent Forms
Chapter 5 - Training
Chapter 6 - Future Research Prospects
Chapter 7 - Providing ART Services to the Economically Weaker Sections of the Society
Chapter 8 - Establishing a National Database for Human Infertility
Chapter 9 - Composition of the National Accreditation Committee
Bibliography
Members of the Expert Group for Formulating the National Guidelines for Accredation,
Supervision and Regulation of ART Clinics in India
Indian Council of Medical Research | National Academy of Medical Sciences (India)
Home Page
158
National Guidelines for Accreditation,

Supervision and Regulation of
ART Clinics in India
Ministry of Health and Family Welfare

Government of India
Indian Council of Medical Research

National Academy of Medical Sciences (India), New Delhi - 110029
2005
i
159
National Guidelines for Accreditation, Supervision and
Regulation of ART Clinics in India
Drafting Committee
1. Dr Baidya N Chakravorty 2. Dr Pushpa M Bhargava

3. Dr Anand Kumar T C 4. Dr Sulochana Gunasheela
5. Dr Sudarsan G Dastidar 6. Dr Mohinder Kochhar
7. Dr Kamini Rao 8. Dr Mehroo D Hansotia
9. Dr Sadhana K. Desai 10. Dr Chander P Puri
11. Dr Firuza R. Parikh 12. Shri Rajeev Dhavan
13. Dr Mira Shiva 14. Dr Lalrintluangi
15. Dr Vikram K Behal 16. Dr Vasantha Muthuswamy
17. Shri Nirakar C Saxena 18. Dr Radhey S Sharma
19. Dr Nomita Chandhiok
Edited by
Dr Radhey S Sharma
Dr Pushpa M Bhargava
Dr Nomita Chandhiok
Shri Nirakar C Saxena

Government of India

National Academy of Medical Sciences (India), New Delhi - 110029
2005
ii
160
© 2005 Indian Council of Medical Research, New Delhi
Printed at S. Narayan & Sons, B-88, Okhla Indl. Area, Phase-II, New Delhi 110 020
iii
161
Contents
Forword xi - xii
Preface xiii - xv
Acknowledgement xvii
Abbreviations xix - xxi
Corrigendum xxiii-xxvi
Chapter 1 1 - 35
Introduction, Brief history of ART and Requirement of ART Clinics 1
1.0 Introduction 3
1.1 Brief History 4
1.1.1 ART – an alternative to reversal of Sterilization 5
1.2 Definitions 5
1.3 Minimal Physical Requirements for an ART Clinic 11
1.3.1 The non – sterile area 11
1.3.2 The sterile area 13
1.3.3 Ancillary laboratory facilities 15
1.4 Back-up Power Supply 17
1.5 Essential Qualifications of the ART Team 17
1.5.1 Gynaecologist 17
1.5.2 Andrologist 19
1.5.3 Clinical Embryologist 20
1.5.4 Counsellors 22
1.5.5 Programme co-ordinator/ director 23
1.6 ART Procedures 23
1.6.1 Artificial insemination with husband’s semen (AIH) 24
1.6.2 Artificial insemination with donor semen (AID) 24
1.6.3 Intrauterine insemination with husband’s or donor
semen (IUI-H or IUI-D) 25
1.6.4 In vitro fertilization and embryo transfer (IVF-ET) 26
iv
162
1.6.5 IVF- associated techniques 27
1.6.6 Intracytoplasmic sperm injection (ICSI) with ejaculated,
epididymal or testicular spermatozoa 27
1.6.7 Oocyte donation (OD) or embryo donation (ED) 28
1.6.8 Cryopreservation 30
1.6.9 In vitro culture media 31
1.6.10 The future ART technologies 32
1.6.11 Caution, precautions and concerns about ART practice 32
Chapter 2 37-53
Screening of Patients for ART: Selection Criteria and Possible
Complications 37
2.1 Patient Selection 39
2.1.1 Husband 39
2.1.2 Wife 39
2.2 Patient Selection for Treatment in Different Infertility
Care Units 40
2.2.1 Single defect in one of the partner 40
2.2.2 Multiple defects in one or both partners 41
2.2.3 No detectable defect in either partner
(Unexplained or idiopathic infertility) 41
2.3 Selection Criteria for ART 43
2.3.1 Selection criteria for in vitro fertilization and embryo
transfer (IVF-ET) 43
2.3.2 Selection criteria for gamete intra-fallopian transfer (GIFT) 45
2.3.3 Choosing between IVF-ET and GIFT 45
2.3.4 Micro-assisted fertilization (SUZI and ICSI) 46
2.4 Complications 46
2.4.1 Multiple gestation 46
v
163
2.4.2 Ectopic pregnancy 47
2.4.3 Spontaneous abortion 47
2.4.4 Preterm birth 47
2.4.5 Ovarian hyperstimulation syndrome 47
2.5 Categories of Infertility Care Units 48
2.5.1 Primary (Level 1A) infertility care units 48
2.5.2 Primary (Level 1B) infertility care units engaging in IUI 50
2.5.3 Secondary (Level 2) infertility care units 51
2.5.4 Tertiary (Level 3) infertility care units 52
Chapter 3 55-76
Code of Practice, Ethical Considerations and Legal Issues 55
3.1 Clinics which should be Licensed 57
3.2 Code of Practice 57
3.2.1 Staff 57
3.2.2 Facilities 58
3.2.3 Confidentiality 58
3.2.4 Information to patient 58
3.2.5 Consent 58
3.2.6 Counselling 58
3.2.7 Use of gametes and embryos 59
3.2.8 Storage and handling of gametes and embryos 59
3.2.9 Research 59
3.2.10 Complaints 59
3.3 Responsibilities of the clinic 60
3.4 Information and Counselling to be given to Patients 61
3.5 Desirable Practices/Prohibited Scenarios 62
3.6 Requirements for a Sperm Donor 65
3.7 Requirements for an Oocyte Donor 66
vi
164
3.8 Requirements for a Surrogate Mother 66
3.9 How may Sperm and Oocyte Donors and Surrogate
Mothers be Sourced? 66
3.9.1 Semen banks 66
3.9.2 Sourcing of oocytes and surrogate mothers 68
3.9.3 Oocyte sharing 68
3.10 Surrogacy: General Considerations 68
3.11 Preservation, Utilization and Destruction of Embryos 70
3.12 Rights of a Child Born through various ART Technologies 70
3.13 Responsibility of the Drug Industry 71
3.14 General Considerations 71
3.15 Responsibilities of the Accreditation Authority 73
3.16 Legal Issues 74
3.16.1 Legitimacy of the child born through ART 74
3.16.2 Adultery in case of ART 75
3.16.3 Consummation of marriage in case of AIH 75
3.16.4 Rights of an unmarried woman to AID 75
3.16.5 Posthumous AIH through a sperm bank 75
3.17 Institutional Ethics Committees 76
Chapter 4 77-97
Sample Consent Forms : 77
4.1 For the Couple 79
4.2 For Artificial Insemination with Husband’s Semen 81
4.3 For Artificial Insemination with Donor Semen 82
4.4 For Freezing of Embryos 84
4.5 For the Procedure of PESA & TESA 86
4.6 Oocyte Retrieval/ Embryo Transfer 88
4.7 Agreement for Surrogacy 91
4.8 For the Donor of Eggs 95
vii
165
4.9 For the Donor of Sperm 97
Chapter 5 99-101
Training 99
5.0 Training 101
Chapter 6 103-106
Future Research Prospects 103
6.0 Future Research Prospects 105
6.1 Preimplantation Genetic Diagnosis and Chromosomal
and Single-Gene Defects 106
Chapter 7 107-109
Providing ART Services to the Economically Weaker Sections
of the Society 107
7.0 Providing ART Services to the Economically Weaker
Sections of the Society 109
Chapter 8 111-113
Establishing a National Database for Human Infertility 111
8.0 Establishing a National Database for Human Infertility 113
Chapter 9 115-118
Composition of the National Accreditation Committee 115
9.0 Composition of the National Accreditation Committee 117
Bibliography 119-122
Members of the Expert Group for Formulating the National
Guidelines for Accreditation, Supervision and Regulation of
ART Clinics in India 123-126
viii
166
Foreword
Shri Prasanna Hota

Secretary
Government of India
Infertility, though not life threatening, can cause intense agony and trauma
to the infertile couples. No data on the extent of infertility prevalent in India is
available; but the multinational study carried out by WHO (Diagnosis and Treatment
of Infertility, ed. P. Rowe and E.N. Vikhlyaeva, 1988) that included India, places
the incidence of infertility between 10 and 15%. Out of the population of 1020
million Indians, an estimated 25% (about 250 million individuals) may be
conservatively estimated to be attempting parenthood at any given time. By
extrapolating the WHO estimates, approximately 13 to 19 million couples are
likely to be infertile in the country at any given time. These couples approach ART
Clinics.
The increasing demand for ART has resulted in mushrooming of infertility
clinics in India. The Assisted Reproductive Technology (ART) in India is being
provided by private sector only. Many of these technologies require enormous
technical expertise and infrastructure. However, the success rate is below 30%
under the best of circumstances. Moreover, it taxes the couple’s endurance
physically, emotionally and monetarily. Many of these clinics do not have adequate
trained manpower and infrastructure facilities to deliver these highly sophisticated
technologies and even services provided by some of these clinics are highly
questionable. In some cases, the infertile couple are being cheated by providing
relatively simple procedure and charged for complicated and expensive procedures.
The procedures, wherein Round Spermatid Nuclear Injection and Pre-implantation
ix
167
Genetic Diagnosis in gender selection of the embryo are used, have not been
universally accepted. These issues are of great concern to the society.
In order to regulate and supervise the ART clinics, the Indian Council of
Medical Research (ICMR) and National Academy of Medical Sciences (NAMS)
have come out with National Guidelines for Accreditation, Supervision and
Regulation of ART Clinics in India. These Guidelines have been evolved after
detailed discussion and debate by experts, practitioners of ART and public.
I take immense pleasure in presenting these Guidelines, which I strongly
feel, would be very useful in regulating and supervising the functioning of ART
Clinics and would be helping the ART Clinics in providing safe and ethical services
to the needy infertile couples. I also place on record our appreciation of the efforts
of the experts of ICMR & NAMS in bringing out these Guidelines.
(Prasanna Hota)
Secretary
Government of India
New Delhi-110011
168
Preface
Prof. N. K. Ganguly
Director General
The successful birth of the world’s first baby conceived by in vitro

fertilization (IVF) and embryo transfer occurred on July 25, 1978, in the UK.
The world’s second IVF baby was born 67 days later on October 3, 1978 in
Kolkata. India’s first scientifically documented IVF baby was, however, born
on August 6, 1986 in Mumbai through the support of the Indian Council of
Medical Research. Since then, over one and half million babies conceived by
Assisted Reproductive Technologies (ART) have reportedly been born
throughout the world.
The advent of any new technology that affects mankind raises several
technical and moral dilemmas and poses many ethical and technical challenges.
ART is no exception. In the Indian context where barrenness is looked down
upon, infertile patients look up to ART as the last resort to parenthood. Some
of them are prepared to go to any extent to achieve their life’s ambition.
Unfortunately, ART has not reached a stage where all forms of infertility can
be treated, nor can any clinic offer a 100% success if the couples were to
undergo any of the assisted reproductive technologies. The ART practitioner
is often faced with a technical challenge of trying to select the right treatment
for a particular type of infertility, knowing fully well that none of the available
techniques offer 100% success. The practitioner also faces moral responsibility
of trying to convince the infertile couple of this fact and let them know the
chances of success and failure by the particular treatment that is being offered.
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The increasing demand for ART has resulted in mushrooming of infertility
clinics in India. There is no reliable information on the number of ART clinics in
India in the absence of a national registry of ART clinics. There is no information
on the follow-up of babies born after the use of ART to know the incidence of
congenital malformation in them. There have been reports in the press of
malpractices carried out by some ART clinics.
Such malpractices are not unique to India but are a global phenomenon.
Many countries have taken steps to prevent such aberrant occurrences. Austria,
Australia, Brazil, Canada, the Czech Republic, Denmark, France, Germany,
Greece, Hungary, Iceland, Israel, Italy, Japan, Korea, Mexico, the Netherlands,
Norway, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland,
Taiwan and Turkey have legislations for the practice of ART. Scientific societies
in Finland, Poland, Portugal and the USA have drawn up guidelines for the practices
of ART. Argentina, Egypt and the UK have both guidelines and legislation.
Guidelines and/or legislation in these countries have been shown to improve the
process of patient care and procedure outcomes.
There are no guidelines for the practice of ART, accreditation of infertility
clinics and supervision of their performance in India. This document aims to fill
this lacuna and also provide a means of maintaining a national registry of ART
clinics in India. The document has been widely publicized, discussed and debated
by expert groups of the ICMR and the National Academy of Medical Sciences
and then by practitioners of ART and the public in Chennai, Jodhpur, Kolkata,
Bangalore, Hyderabad and Mumbai. These discussions involved over 4000
participants including doctors, scientists, bureaucrats, legal experts, infertile couples
and the general public. This document was also put on the Council’s website and
elicited many comments and responses.
All attempts have been diligently made to encompass all points of view
and bring out a document that conveys the views of the vast majority of participants
in the above mentioned discussions and debates.
This document should be useful to the infertility clinics as well as to those
who seek the services of such clinics. However, as ART is an evolving field, this
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document will need to be periodically reviewed. This will be a challenging task both
for the practitioners of ART and the regulatory authority that is yet to be established.
(Prof. N. K. Ganguly)
Director General
New Delhi-110029
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Guidelines for ART Clinics in India ICMR/NAMS
171
Acknowledgements
The Council gratefully acknowledges the valuable contribution of all the
members of the Expert Committee responsible for formulating these guidelines, for
providing continued guidance in drafting and finalizing the guidelines. We are extremely
grateful to the Chairpersons of the subcommittees of the Expert Committee for
conducting regional discussions and preparing the draft document on the respective
topics assigned to them.
This document is a concerted effort made possible by the advice, assistance
and co-operation of many individuals, institutions and government and non-governmental
organizations, specially the National Academy of Medical Sciences (NAMS), The
Medically Aware and Responsible Citizens of Hyderabad (The MARCH), Indian
Society for the Study of Reproduction and Fertility (ISSRF) and Federation of
Obstetrics and Gynaecology Society of India (FOGSI).
The suggestions and advice emerging from the workshop sponsored by the
National Academy of Medical Sciences held on 16th September 2001 at Bangalore
were of great significance. Therefore, the Council is particularly grateful to the
participants of the NAMS workshop (i.e. Manohar, Aruna Sivakami, J Mehta, S.
Narang, M. S. Sreenivas, M. Gourie Devi, B. Kalyan, N. Krishnan, N. Pandiyan, K.
S. Jayaraman, P. B. Seshagiri, R. H. Mehta, Seema Singh, P. V. Kulkarni, Lalitha, P.
Sarkar, M. Sarkar, M. Priya, K. Nath, M. Nirad, D. Raghunath, Gopinathan, R. S.
Sharma, N. C. Saxena, V. Muthuswamy, B. N. Chakravarthy, C. S. Bhaskaran, M.
Rajalakshmi and T. C. Anand Kumar).
Special thanks are due to Dr. P. M. Bhargava not only for his initiative,
professional and editorial inputs and consistent interest in and enthusiasm for the
guidelines, but also doing everything in good humour, inspite of continual office
interruptions and information overload on the various topics of the guidelines.
We are also grateful to the National Commission for Women and the
National Human Rights Commission for their valuable advise.
Secretarial assistance provided by Mr. Mahesh Kumar is gratefully
acknowledged.
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Abbreviations
AIDS - Acquired Immune Deficiency Syndrome
ASRM - American Society for Reproductive Medicine
AI - Artificial Insemination
AID - Artificial Insemination with Donor Semen
AIH - Artificial Insemination with Husband’s Semen
ART - Assisted Reproductive Technology
BBT - Basal Body Temperature
CO2 - Carbon Dioxide
CC - Clomiphene Citrate
CASA - Computer-Aided Sperm Analysis
CBAVD - Congenital Bilateral Absence of Vas Deferens
CMV - Cytomegalo Virus
DHEA - Dehydro-epiandrostendione
DNA - Deoxyribonucleic Acid
DMSO - Dimethylsulfoxide
ED - Embryo Donation
ELSNI - Elongated Spermatid Nuclear injection
ESHRE - European Society for Human Reproduction and Embryology
FISH - Fluorescent in situ Hybridization
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FSH - Follicle Stimulating Hormone
GIFT - Gamete Intrafallopian Transfer
GnRH - Gonadotropin Releasing Hormone
GLP - Good Laboratory Practices
HBV - Hepatitis B Virus
HCV - Hepatitis C Virus
hCG - Human Chorionic Gonadotropin
hMG - Human Menopausal Gonadotropin
HIV - Human Immunodeficiency Virus
HOST - Hypo-Osmotic Swelling Test
ICMR - Indian Council of Medical Research
ICPD - International Conference for Population and Development
IFFS - International Federation of Fertility Societies
ICSI - Intracytoplasmic Sperm Injection
IUI - Intra-uterine Insemination
IRR - Institute for Research in Reproduction, (now National Institute

for Research in Reproductive Health, NIRRH)
IVF-ET - In vitro Fertilization–Embryo Transfer
IVMTS - In vitro Maturation of Testicular Sperm
LH - Luteinizing Hormone
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OD - Oocyte Donation
OT - Operation Theatre
OHS - Ovarian Hyperstimulation Syndrome
PESA - Percutaneous Epididymal Sperm Aspiration
PGD - Pre–implantation Genetic Diagnosis
PCOS - Polycystic Ovarian Syndrome
PCR - Polymerase Chain Reaction
RNA - Ribonucleic Acid
SCMPT - Sperm Cervical Mucous Penetration Test
SOP - Standard Operating Procedure
TESA - Testicular Sperm Aspiration
TESE - Testicular Sperm Extraction
TSH - Thyroid Stimulating Hormone
TVS - Transvaginal Sonography
UPS - Uninterrupted Power Supply
WHO - World Health Organization
WMA - World Medical Assembly
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Corrigendum
(1) 1.2.1 Artificial Insemination (AI)
AI is the procedure of artificially transferring semen into

reproductive system of a woman. This technique comprises
artificial insemination with husband’s (AIH) or with donor sperm
(AID). (Page No. 5)
(2) 1.5.5 Programme co-ordinator/director
This should be a senior person who has had considerable

experience in handling all aspects of ART. (Page No. 23)
(3) 1.6 ART Procedure
“National Accreditation Committee” appearing in para

1.6 may be read as “National Advisory Committee”.
(Page No. 24)
(4) 1.6.10 The future ART technologies
“National Accreditation Committee” appearing in para

1.6.10 may be read as “National Advisory Committee”. (Page
No. 32)
(5) 3.14.7 The State Government would close down any unregulated clinics
not satisfying the above criteria. (Page No. 73)
(6) 3.15 Responsibilities of the Accreditation Authority
The para 3.15 may be read as follows:
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3.15 Responsibilities of the Accreditation/Appropriate
Authority
3.15.1 State Accreditation Authority :
A State Accreditation Authority will be set up by the

State /UT Governments through their Department of Health and
/or Family Welfare to oversee all matters relating to accreditation,
supervision and regulation of ART Clinics in the States/UTs in
accordance with the Guidelines. The functions of the
Accreditation Authority, inter-alia, include-
i) to review the activities of Appropriate Authorities

functioning in the State and take appropriate action
against them;
ii) to monitor the implementation of the provision of the
Guidelines by ART clinics;
iii) to order closure of an ART Clinic if the ethical Guidelines
and operative procedures laid down in the Guidelines
are not followed.
3.15.2 Appropriate Authority.
The State Government may also set up one or more

Appropriate Authorities for implementation of the Guidelines for
the whole or a part of the State having regard to the number of
ART Clinics. Functions of the Appropriate Authority are:
- to grant or suspend registration of an ART Clinic;

- to enforce the provisions of the Guidelines by ART
Clinics;
- to investigate complaints of breach of the Guidelines;
- to visit any ART Clinic/Centre accredited or not
accredited, once a year with or without prior information
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to the clinic/centre, to determine if the ethical guidelines
and operative procedures are being followed. If not,
the Authority will point out lapses to the clinic/centre in
writing. If these lapses continued for a maximum period
of six months (during which period that clinic shall not
engage in any activity related to the lapses), the
Appropriate Authority would recommend to the State
Accreditation Authority that the clinic/centre may be
ordered to be closed;
- to impose a fine or a penalty on the clinic/centre for
violation of any provisions of Guidelines as per
delegation of powers by the State Accreditation
Authority;
- to visit and regulate semen banks in the manner
mentioned above;
- any other function as directed by Accreditation Authority
3.15.3 Complaints Redressal Mechanism
A client of an ART Clinic or any other person can file a

complaint against an ART Clinic for breach of any provisions of
the Guidelines or in respect of any related matter to the
Appropriate Authority. The Appropriate Authority shall investigate
such complaints and take appropriate action under intimation to
the complainant.
3.15.4 Central Advisory Committee
Ministry of Health and Family Welfare, Government of

India will set up a National Advisory Committee under the
Chairmanship of Secretary, Health & Family Welfare and
Director General, ICMR as Co-chairman. The composition of
the Committee is given in Chapter 9. The National Advisory
Committee will review and monitor the implementation of the
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Guidelines and advise the Central Government on all policy
matters relating to regulation of ART Clinics.
(7) 3.16.4 Rights of an unmarried woman to AID
Para 3.16.4 is to be deleted. (Page No. 75)
(8) 5.0 Training
The last three lines of page 101 may be read as: Such
conference must be encouraged through organization such as
the Indian Council of Medical Research (ICMR), Department
of Science and Technology (DST), Department of Biotechnology
(DBT), Council of Scientific and Industrial Research (CSIR) and
the various science academies in India. (Page 101)
(9) 9.0 Composition of the National Advisory Committee.
Executive Secretary: A Officer not below the rank of Joint

Secretary in the Ministry of Health and Family Welfare, Govt. of
India. (Page 117)
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Chapter 1
Introduction, Brief History of ART

and
Requirements of ART Clinics
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1 Introduction
Infertility, though not life threatening, causes intense mental agony and
trauma that can only be best described by infertile couples themselves. There are
no detailed figures of the extent of infertility prevalent in India but a multinational
study carried out by WHO (Diagnosis and treatment of infertility, ed. P. Rowe
and E. M. Vikhlyaeva, 1988) that included India, places the incidence of infertility
between 10 and 15%. Out of a population of 1000 million Indians, an estimated
25% (250 million individuals) may be conservatively estimated to be attempting
parenthood at any given time; by extrapolating the WHO estimate, approximately
13 to 19 million couples are likely to be infertile in the country at any given time.
Prevention and appropriate treatment of infertility has been included in
the ICPD (International Conference on Population and Development) Programme
of Action; it follows that alleviation of infertility should be included as a component
of the primary health care system. Most types of infertility such as reproductive
tract infections (RTI) and genital tuberculosis, are preventable and amenable to
treatment. About 8% of infertile couples, however, need serious medical
intervention involving the use of advanced ART (Assisted Reproductive
Technologies) procedures such as IVF (In virto Fertilization) or ICSI
(Intracytoplasmic Sperm Injection). Such advanced treatment is expensive and
not easily affordable to the majority of Indians. Further, the successful practice of
ART requires considerable technical expertise and expensive infrastructure.
Moreover, the success rate of any ART procedure is below 30% under the best
of circumstances. Infertility, specially in our country, also has far-reaching societal
implications. Therefore, with the rapidly increasing use of ART in our country, it
has become imperative to ensure their safety and have safeguards against their
possible misuse.
Scientific societies around the world, such as the ASRM, ESHRE and
IFFS, have drawn up guidelines for the safe and ethical practice of ART. The
European Union and the Governments of several countries such as Australia, the
UK and the USA have taken steps to accredit and supervise the performance of
infertility clinics.
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At present here are neither guidelines nor a legislation in regard to the
practice of ART in India. This document aims to fill this lacuna. It has been prepared
after extensive consultations held at both the ICMR and other national institutions,
with scientists, medical practitioners, lawyers, social scientists and activists.
The present guidelines are meant to ensure that ART clinics in India are
accredited, regulated and supervised to assure the patients as well as the public
that our ART clinics offer services that are at par with those available anywhere in
the world. Medical malpractice now comes under the purview of the legal redressal
machinery of the country; this makes it all the more necessary to have national
guidelines for the practice of ART.
1.1 Brief History of IVF in India

The world’s first IVF baby, Louise Brown, was born on July 25, 1978,
in the UK through the efforts of Dr. Robert G Edwards and Dr. Patrick Steptoe.
The world’s second and India’s first IVF baby, Kanupriya, alias Durga, was born
67 days later on October 3, 1978, through the efforts of Dr. Subhas Mukherjee
and his two colleagues in Kolkata.
Dr. Mukherjee and his colleagues published a short note on their above
work, in the Indian Journal of Cryogenics (Vol. 3: page 80, 1978). The techniques
used by Mukherjee were markedly different from those used by Edwards and
Steptoe. Mukherjee was the first person in the world to use
(a) gonadotropins for ovarian stimulation prior to ovum pick-up in
an IVF treatment cycle;
(b) the transvaginal route by colpotomy for harvesting oocytes; and
(c) freezing and thawing of human embryos before transferring them
into the uterus that led to the successful birth of Durga.
India’s first scientifically documented IVF baby, Harsha, was born
on August 6, 1986, in Mumbai, through the collaborative efforts of the ICMR’s
Institute for Research in Reproduction and the King Edward’s Memorial
Hospital (KEM). This work was executed after being approved by the
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Scientific Advisory Committee of the ICMR’s Institute for Research in
Reproduction and the Ethics Committee for Human Experimentation of the
KEM Hospital. Full details of this and other studies in this area were published
in the ICMR Bulletin (1986: No. 16) and in peer reviewed national (Natl.
Med. J. India 1:10, 1988) and international journals (J. In vitro Fertilization
& ET 5:376, 1988). Births of IVF babies were reported subsequently during
the same year by two other clinics in India. There are an estimated 250 IVF
clinics in India today.
1.1.1 ART - an alternative to reversal of Sterilization
Infertility, consequent to use of terminal methods of contraception
under the Family Planning Programme, may sometimes need to be reversed
for personal reasons such as having lost a child/children born prior to
sterilization. IVF is one of the options for women in whom fallopian tubes
have been surgically severed and where recanalisation for correction of
infertility has failed.
1.2 Definitions
1.2.1 Artificial Insemination (AI)
AI is the procedure of transferring semen into the reproductive system
of a woman. This technique comprises artificial insemination with husband’s
(AIH) or with donor sperm (AID).
1.2.2 Aspiration cycle
Initiated ART cycle in which one or more follicles are punctured
and aspirated irrespective of whether or not oocytes are retrieved.
1.2.3 Assisted Hatching
Assisted hatching allows easier release of the embryo from its shell
(zona pellucida), helping implantation and increasing the pregnancy rate.
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1.2.4 Assisted Reproductive Technology (ART)
For the purpose of these guidelines, ART would be taken to encompass
all techniques that attempt to obtain a pregnancy by manipulating the sperm or/
and oocyte outside the body, and transferring the gamete or embryo into the uterus.
1.2.5 Blastocyst
An embryo with a fluid-filled blastocele cavity (usually developing by
five or six days after fertilization).
1.2.6 Controlled ovarian hyperstimulation (COH)
Medical treatment to induce the development of multiple ovarian follicles
to obtain multiple oocytes at follicular aspiration.
1.2.7 Cryopreservation
Freezing and storage of gametes, zygotes or embryos
1.2.8 Donation of Gametes
Donation of gametes is a process by which a person voluntarily offers
his or her gametes for the process of procreation.
1.2.9 Ectopic pregnancy
A pregnancy in which implantation takes place outside the uterine
cavity
1.2.10 Embryo
Embryo is defined as the fertilized ovum that has begun cellular
division and continued development up to the blastocyst stage till the end of
eight weeks.
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1.2.11 Embryo donation
The transfer of an embryo resulting from gametes that did not originate
from the recipient and/or her partner.
1.2.12 Embryo transfer (ET)
Procedure in which embryo(s) are placed in the uterus or fallopian tube.
1.2.13 Fertilization
The penetration of the ovum by the spermatozoon and fusion of genetic

materials resulting in the development of a zygote.
1.2.14 Foetus
The product of conception starting from completion of embryonic

development (at eight completed weeks after fertilization) until birth or
abortion.
1.2.15 Foetal Reduction
Foetal reduction is an invasive/interventional process by which a

higher order multiple pregnancy is reduced to a single or twin pregnancy in
order to improve the perinatal outcome.
1.2.16 Gamete
Oocytes and sperm are called gametes.
1.2.17 Hatching
It is the process that precedes implantation by which an embryo at

the blastocyst stage separates from the zona pellucida.
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1.2.18 ICSI (Intracytoplasmic Sperm Injection)
In ICSI, a single sperm is injected into the cytoplasm of the ovum to

effect fertilization, before the fertilized ovum is transferred to the uterus of
the woman.
1.2.19 Implantation
The attachment and subsequent penetration by the zona-free
blastocyst (usually in the endometrium) which starts five to seven days
following fertilization.
1.2.20 Infertility
Failure to conceive after at least one year of unprotected coitus
1.2.21 Intrauterine Insemination (IUI)
Intrauterine Insemination involves the introduction of sperm into
the uterus of the woman. In IUI, specially prepared sperm are injected into
the uterine cavity via a fine cannula passed through the cervix. At this site,
the sperm are near the uterine entrance of each of the two fallopian tubes and
thus have a shorter distance to swim in order to reach the oocyte(s) released
at the time of ovulation.
1.2.22 IVF-ET (In vitro Fertilization-Embryo Transfer)
In vitro Fertilization-Embryo Transfer (IVF-ET) is the fertilization
of an ovum outside the body and the transfer of the fertilized ovum to the
uterus of a woman.
1.2.23 IVMTS & IVMO (In vitro Maturation of Testicular
Sperm and In vitro Maturation of Oocytes)
In vitro Maturation of Testicular Sperm (IVMTS) involves keeping
the testicular sperm in a culture medium under optimal conditions where they
can attain physiological maturity and acquire motility.
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In vitro maturation of immature oocytes involves keeping the immature
oocytes in an appropriate culture medium under optimal conditions where they
can attain physiological maturity.
1.2.24 Oocyte donation
An ART procedure performed with third-party oocytes
1.2.25 Ovum/Oocyte
Ovum/oocyte is the female gamete produced in the ovary.
1.2.26 PESA (Percutaneous Epididymal Sperm Aspiration)
and TESA/TESE (Testicular Sperm Aspiration/
Extraction)
Percutaneous Epididymal Sperm Aspiration (PESA) and Testicular
Sperm Aspiration (TESA) are simplified, minimally invasive outpatient
procedures that allow the physician to recover the sperm for fertilization in
patients with obstructive azoospermia (lack of sperm in semen).
PESA requires a needle to be introduced into the epididymis and the
contents aspirated. The aspirate is observed under the microscope to determine
if motile sperm are present.
In TESA, the needle is introduced into the testicle itself.
1.2.27 Pre–implantation Genetic Diagnosis (PGD)
Pre–implantation Genetic Diagnosis is a technique in which an
embryo formed through IVF is tested for specific genetic disorders (e.g. cystic
fibrosis) or other characteristics prior to implantation.
1.2.28 Preterm Birth
A birth which takes place after at least 20, but less than 37, completed
weeks of gestation. This includes both live births and stillbirths. Births are
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counted as birth events (e.g. a twin or triplet live birth is counted as one birth
event).
1.2.29 Semen
A thick, whitish fluid discharged through the penis during ejaculation
containing spermatozoa, secretions from the testes, seminal vesicles, prostate
gland, bulbo-uretheral and other glands associated with the male reproductive
system.
1.2.30 Semen Donor
Semen obtained from third party for purpose of inseminating the
wife in cases where husband is unable to produce healthy semen.
1.2.31 Sperm
Sperm are the male gametes produced in the testicles.
1.2.32 Spontaneous abortion
Spontaneous loss of a clinical pregnancy before 20 completed weeks
of gestation or, if gestational age is unknown, a weight of 500 g or less.
1.2.33 Surrogacy
Surrogacy is an arrangement in which a woman agrees to carry a
pregnancy that is genetically unrelated to her and her husband, with the
intention to carry it to term and hand over the child to the genetic parents for
whom she is acting as a surrogate.
1.2.34 Surrogacy with Oocyte Donation
Surrogacy with oocyte donation is a process in which a woman allows
insemination by the sperm/semen of the male partner of a couple with a view
to carry the pregnancy to term and hand over the child to the couple.
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1.2.35 Zygote
Fertilized oocyte prior to first cell division is called zygote
1.3 Minimal Physical Requirements for an ART

Clinic
A well designed ART clinic of Level 2 or Level 3 (Sections 2.5.3
and 2.5.4) should have a non-sterile and a strictly sterile area as detailed
below. Some of the spaces mentioned below could be combined (that is, the
same space may be used for more than one purpose) as long as such a step
does not compromise the quality of service. However, the space provision
for the sterile area cannot be combined with those for the non-sterile area and
vice-versa. For level 1B infertility care units (section 2.5.2), a strictly sterile
area will not be required. The space requirement, however, will include, a
reception area, a waiting room for the patients, a consulting room for the
gynaecologist, and requirements mentioned under 1.3.1.8, 1.3.1.9 and
1.3.1.10.
1.3.1 The non-sterile area
The non-sterile area must include what is listed under 1.3.1.1 to
1.3.1.9 below.
1.3.1.1 A reception and waiting room for patients
1.3.1.2 A room with privacy: A room with privacy for interviewing and
examining male and female partners independently is essential.
Evaluation of infertility necessitates history taking of the most
intimate sexual practices between the couples. This is followed by
close examination of the reproductive tract and sexual organs.
Adequate measures must be taken to ensure that history taking and
examination are carried out in strict privacy, maintaining the dignity
of the patients. In case a male doctor examines a female patient,
there must always be a female attendant present. The room must be
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equipped with an examination table and gynecological instruments for
examining the female per vaginum, an appropriate ultrasonographic
machine with a probe for transvaginal examination of the female and
examination of the testes and excurrent male reproductive tract. A colour
Doppler would be useful but not essential.
1.3.1.3 A general-purpose clinical laboratory

1.3.1.4 Store room: A well-stocked store for keeping essential stock of
especially those items that have to be imported, precluding the need
to be caught short in the middle of treatment. Facilities must be
available for storing sterile (media, needles, catheters, petri dishes
and such-like items) and non-sterile material under refrigerated and
non-refrigerated conditions as appropriate.
1.3.1.5 Record room: Record keeping must be computerized as far as
possible so that data is accessible retrospectively for analysis or when
called upon by the supervisory agency. There are many software
programmes for this purpose, which are commercially available today.
A user-friendly one should be chosen that could be used widely.
Besides containing essential details of the patient’s records, it must
contain history of the cause of infertility as diagnosed earlier, results
of new diagnosis if relevant, the treatment option best suited for the
particular patient, the treatment carried out and the outcome of
treatment, and follow-up if any. Any other noteworthy point such as
possible adverse reaction to drugs, must be recorded. ICMR should
make an effort to devise a form for basic data recording, which would
be suitable for India.
1.3.1.6 Autoclave room: A separate facility must be available for sterilizing
and autoclaving all surgical items as well as some of those to be
used in the in vitro culture laboratory.
1.3.1.7 Steps for vermin proofing: Adequate steps should be taken to make
the whole clinic vermin proof, with suitable traps for preventing
insects and other forms of unwanted creatures entering the clinic.
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This essential detail should be planned at an early stage because no
pesticide can be used in a fully functional IVF clinic, as it could be
toxic to the gametes and embryos.
1.3.1.8 Semen collection room: This must be a well-appointed room with
privacy and an appropriate environment; it should be located in a
secluded area close to the laboratory. Such a facility must be available
in-house rather than having the patient collect the sample and bring
it to the laboratory for analysis as, in the latter case, semen quality
and identity is likely to be compromised. Procedures for collection
of semen as described in the WHO Semen Analysis Manual must be
followed with special reference to the type of container used; these
containers must be sterile, maintained at body temperature and non-
toxic. This room must have a washbasin with availability of soap
and clean towels. The room must also have a toilet and must not be
used for any other purpose.
1.3.1.9 Semen processing laboratory: There must be a separate room with
a laminar air flow for semen processing, preferably close to the semen
collection room. This laboratory must also have facilities for
microscopic examination of post-coital test smears. Good Laboratory
Practice (GLP) guidelines as defined internationally must be followed.
Care must be taken for the safe disposal of biological waste and
other materials (syringes, glass slides, etc.). Laboratory workers
should be immunized against hepatitis B and tetanus.
1.3.1.10 Clean room for IUI: There must be a separate area/room with an
appropriate table for Intra-Uterine Insemination (IUI).
1.3.2 The sterile area

The sterile area shall house the operation theatre, a room for
intrauterine transfer of sperm or embryos and an adjoining
embryology laboratory. Entry to the sterile area must be strictly
controlled by an anteroom for changing footwear, area for changing
into sterile garments and a scrub-station. The sterile area must be
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air-conditioned where fresh air filtered through an approved and
appropriate filter system is circulated at an ambient temperature (22-
0
25 C).
1.3.2.1 The operation theatre: This must be well equipped with facilities
for carrying out surgical endoscopy and transvaginal ovum pick-up.
The operation theatre must be equipped for emergency resuscitative
procedures.
1.3.2.2 Room for intrauterine transfer of embryo: This room must be a
sterile area having an examination table on which the patient can be
placed for carrying out the procedure and rest undisturbed for a
period of time.
1.3.2.3 The embryology laboratory complex: The embryology laboratory
must have facilities for the control of temperature and humidity and
must have filtered air with an appropriate number of air exchanges
per hour. Walls and floors must be composed of materials that can
be easily washed and disinfected; use of carpeting must be strictly
avoided. The embryology laboratory must have the following:
• a laminar flow bench with a thermostatically controlled heating
plate
• a stereo microscope
• a routine high-powered binocular light microscope
• a ‘high resolution’ inverted microscope with phase contrast or
Hoffman optics, preferably with facilities for video recording
• a micromanipulator (if ICSI is done)
• a CO2 incubator, preferably with a back up
• a hot air oven
• a laboratory centrifuge
• equipment for freezing embryos in a programmed manner
• liquid nitrogen cans
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• a refrigerator
Appropriate steps need to be taken for the correct identification of
gametes and embryos to avoid mix-ups. All material from the
operation room, culture dishes and Falcon tubes for sperm collection
(including lids), must bear the name of the patient. In the incubator,
identified oocytes and sperm should be kept together on the same
tray and double-checked. Pipettes used should be disposed off
immediately after use. The embryology laboratory must have a daily
logbook in which all the day’s activities are recorded, including the
performance of the equipment.
1.3.3 Ancillary laboratory facilities

The infertility clinic need not have in-house facilities to perform all
the procedures necessary to diagnose infertility, such as those
mentioned below. They can be farmed out to speciality laboratories
specializing in delivering such services, as long as they are located
in the neighborhood.
1.3.3.1 Hormone and other assays: The infertility clinic must have ready
access to laboratories that are able to carry out immunoassays of
hormones (FSH, LH, Prolactin, hCG, TSH, Insulin, Estradiol,
Progesterone, Testosterone and DHEA) and tests such as for HIV
and Hepatitis B. Endocrine evaluation constitutes an essential
diagnostic procedure to determine the cause of infertility. It is also
necessary to estimate blood estradiol in samples taken from a woman
undergoing controlled ovarian hyperstimulation, and have the result
on the same day to determine the dose of drugs to be given for
induction of ovulation. Accurate monitoring of endocrine response
to controlled ovarian stimulation goes a long way in preventing
ovarian hyperstimulation.
1.3.3.2 Microbiology and histopathology: Another important facility in
an ART clinic (or easily accessible to it) would be that of a
microbiology laboratory that can carry out rapid tests for any infection,
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and a clinical chemistry laboratory. Facilities for carrying out
histopathological studies on specimens obtained from the operation
theatre would also be desirable.
1.3.3.3 Maintenance of the laboratories: Each laboratory should maintain in
writing, standard-operating manuals for the different procedures carried
out in the laboratory. It should be ensured that there is no “mix up” of
gametes or embryos. The patient’s name should be clearly labeled on all
the tubes, dishes and pipettes containing the gametes and embryos. All
pipettes should be immediately discarded after use.
Laminar flowhoods, laboratory tables, incubators and other areas where
sterility is required must be periodically checked for microbial
contamination using standard techniques, and a record of such checks
must be kept.
A logbook should be maintained which records the temperature,
carbon dioxide content and humidity of the incubators and the
manometer readings of the laminar air flow.
All instruments must be calibrated periodically (at least once every
year) and a record of such calibration maintained.
1.3.3.4 Quality of consumables used in the laboratory: All disposable
plasticware must be procured from reliable sources after ensuring
that they are not toxic to the embryo. Culture media used for
processing gametes or growing embryos in vitro should be preferably
procured from reliable manufacturers. Each batch of culture medium
needs to be tested for sterility, endotoxins, osmolality and pH. The
embryologist should know the composition of the media that are
being used. Most media are supplemented with serum; they should,
therefore, be tested for antibodies to HIV 1 and 2, Hepatitis B Surface
Antigen and Hepatitis C RNA.
1.4 Back-up Power Supply
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There should be no interruption in power supply to the incubator and to
other essential services in the clinic. Given the power supply situation in India, it
is, therefore, imperative that a power back up in the form of UPS systems and/or
a captive power generation system is available in infertility clinics offering ART
services.
1.5 Essential Qualifications of the ART Team

The practice of ART requires a well-orchestrated teamwork between
the gynaecologist, the andrologist and the clinical embryologist supported
by a counsellor and a programme coordinator/director. The staff
requirements given below would be mandatory for Level 2 and Level 3 clinics
(see Section 2.5.3 and 2.5.4). In the case of small Level 2 and Level 3 clinics,
the services of the andrologist, the clinical embryologist and/or the counsellor
could be shared.
1.5.1 Gynaecologist
The minimal qualification for a gynaecologist in a Level 1B, Level 2
or Level 3 clinic (see Sections 2.5.2, 2.5.3 and 2.5.4) is a post-graduate
diploma or degree in gynaecology. Additional experience should include:
© Understanding the causative factors of male and female infertility.
© Acquiring knowledge of the practice and use of diagnostic
methods for determining the cause of infertility.
© Acquiring knowledge of the clinical aspects of reproductive
endocrinology and the reproductive defects caused by endocrine
factors, and an understanding of the limitations of the currently
used hormone assay methods, and of the techniques available
for medically or surgically correcting endocrine disorders.
© Acquiring competence/skills in gynecological ultrasonography
to diagnose reproductive tract anomalies, monitoring ovarian and
uterine response to ovarian stimulation, picking up oocytes at
the most appropriate time, and transferring embryos by any one of
the several methods currently available to handle embryo transfer in
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‘difficult cases’.
© The gynaecologist must be well versed, particularly in the
pharmacology of hormone action, and know how to avoid
situations such as Ovarian Hyperstimulation Syndrome that can
pose a great health hazard.
The responsibilities of the gynaecologist would include the following:
• Interviewing of the infertile couple initially.
• History taking.
• Physical examination of the female.
• Recommending appropriate tests to be carried out, interpreting
them and treating medical disorders (infections, endocrine
anomalies).
• Carrying out laparoscopy or sonohysterosalpingography for
determining the status of the uterus and the fallopian tube.
• Advising the couple on planned relationship in simple cases.
• Carrying out AIH, AID, IUI, IVF or ICSI as the case may
warrant, based on diagnostic evidence.
In case of male factor infertility, if the gynaecologist is confident
and competent, he/she can treat such cases or refer them to the andrologist.
The treating doctor must be responsible for maintaining all records of
diagnosis, treatment given and consent forms. Before any treatment is given,
it is advisable that the couple is referred to the counsellor, with all the details
of the case, for proper advise and counselling. It would be the gynaecologist’s
responsibility to see that all equipment and instruments in the operation theatre
are properly functional and in order, and that a logbook is maintained of their
use and operation.
1.5.2 Andrologist
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Fifty percent of infertility cases are related to male factors, many of
which can be treated by specific ART procedures or other less invasive
procedures. Andrology, a subject related to male reproduction, does not
constitute a formal course in the medical curriculum in India, although several
journals in andrology are published from different parts of the world including
China. There is also an International Andrological Society with branches or
affiliated societies all over the world. In India it is the urologist with a post-
graduate degree in urology that often takes on the task of treating male
infertility. Such individuals must receive additional training in diagnosis of
various types of male infertility covering psychogenic impotence, anatomical
anomalies of the penis which disable normal intercourse, endocrine factors
that cause poor semen characteristics and/or impotence, infections, and causes
of erectile dysfunction.
© The andrologist must have knowledge of the occupational
hazards, infections and fever that cause reversible or irreversible
forms of infertility, and knowledge of ultrasonographic or
vasographic studies of the reproductive excurrent ducts to detect
partial occlusion that can be surgically corrected.
© He/she must understand the principles of semen analysis and their
value and limitation in diagnosis of male fertility status. The
person should also be able to interpret the fertility status of the
male from the result of semen analysis. The andrologist must be
able to collect semen by prostatic massage for microbial culture
in cases where infection may lie in the upper regions (prostate,
seminal vesicles) of the reproductive tract. He/she should also
be able to collect spermatozoa from the excurrent ducts or testis
for use in ICSI and must also be knowledgeable about the genetic
implications of using poor-quality sperm for ICSI as this
technique can vertically transfer the genetic defects of the father
to the child. He/she should be familiar with the surgical
procedures available for correcting an anatomical defect in the
reproductive system such as epididymo-vasal re-anastmosis and
varicocoelectomy.
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© An individual may act as an andrologist for more than one clinic but
each clinic where the andrologist works must own responsibility for
the andrologist and ensure that the andrologist is able to take care of
the entire work load of the clinic without compromising on the quality
of service.
The responsibilities of the andrologist would include the following:
• Recording case histories.

• Prescribing appropriate diagnosis and treatment based on the
diagnosis.
• Carrying out such surgical procedures as warranted by the
diagnosis.
• Maintaining all the records, from the case history to the treatment
given, and the patient consent forms.
• Referring the couple to the gynaecologist for carrying out the
appropriate ART procedure if necessary, after the male factor
has been duly investigated.
• Referring the couple to the counsellor if necessary.
• In cases of surgical intervention, making sure that the operation
theatre is fully functional and all supplies are available before
the start of any surgical procedure.
• Entering any deficiency that needs attention in the operation
theatre logbook.
1.5.3 Clinical Embryologist
The clinical embryologist must be knowledgeable in mammalian
embryology, reproductive endocrinology, genetics, molecular biology,
biochemistry, microbiology and in vitro culture techniques. The biologist must
also be familiar with ART. He/she must be either a medical graduate or have
a post-graduate degree or a doctorate in an appropriate area of life sciences.
(In the case of a clinic in existence for at least one year before the promulgation
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of these guidelines, a person with a B Sc or BV Sc degree but with at least five
years of first-hand, hands-on experience of the techniques mentioned below and
of discharging the responsibilities listed below, would be acceptable for functioning
as a clinical embryologist in the particular clinic. Such persons would also be
eligible to take a test to be designed and conducted by an appropriate designated
authority, to qualify for a position of a clinical embryologist in a new clinic.) He/
she must be familiar with the following:
© Principles and practice of semen analysis and cryopreservation

of semen.
© Cytology of mammalian and human oocyte to identify stages of
oocyte maturation accurately.
© All aspects of embryology including developmental biology.
© Cell biological techniques used in cell and tissue culture.
© Molecular biology and genetics of human reproduction.
© Micromanipulation of sperm and oocytes for carrying out ICSI
and single-cell biopsies of embryos for preimplantation genetic
diagnosis.
© Principles and functioning of all the equipment used in the
laboratory.
© In vitro fertilization of oocytes after processing the gametes.
© Principles and practice of embryo freezing.
The responsibilities of the clinical embryologist would be:
• To ensure that all the necessary equipments are present in the

laboratory and are functional.
• To perform all the procedures pertaining to processing, handling
and culturing of gametes and embryos in the laboratory and hand
over the embryo to the gynaecologist.
• To maintain records of all the procedures carried out in the laboratory.
• In case of shortage of adequately trained clinical embryologists, an
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individual may act as a clinical embryologist for more than one clinic
but each clinic where the person works must own responsibility for
the embryologist and ensure that the embryologist is able to take care
of the entire work load of the clinic without compromising on the quality
of service. An embryologist must not be associated with more than
two centers at any given time.
1.5.4 Counsellors
Counsellors are an important adjunct to any infertility clinic. Indeed, in
the UK, counsellors are appointed by the clinic but they report to an independent
body. This ensures that there is fair play by the clinic and the patients are adequately
informed of what and what not to expect from the treatment offered to them.
Counselling for ART is not taught as a separate subject anywhere. A person who
has at least a degree (prefarably a postgraduate degree) in Social Sciences,
Psychology, Life Sciences or Medicine, and a good knowledge of the various
causes of infertility and its social and gender implications, and the possibilities
offered by the various treatment modalities, should be considered as qualified to
occupy this position. The person should have a working knowledge of the
psychological stress that would be experienced by potential patients, and should
be able to counsel them to assuage their fears and anxiety and not to have
unreasonable expectations from ART. A member of the staff of an ART clinic who
is not engaged in any other full-time activity in the clinic can act as a counsellor.
The counsellor must invariably appraise the couple of the advantages of
adoption as against resorting to ART involving a donor. An individual may act as a
counsellor for more than one clinic but each clinic where the counsellor works
must own responsibility for the counsellor and ensure that the counsellor is able to
take care of the entire counselling load of the clinic without compromising on the
quality of the counselling service.
1.5.5 Programme co-ordinator/director
This should be a senior person who has had considerable experience in
all aspects of ART. The programme co-ordinator/director should be able to co-
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ordinate the activities of the rest of the team and take care of staff administrative
matters, stock keeping, finance, maintenance of patient records, statutory
requirements, and public relations. He/she should ensure that the staff are keeping
up with the latest developments in their subject, by providing them with information
from the literature, making available to them access to the latest journals, and
encouraging them to participate in conferences and meetings and present their
data. The programme co-ordinator/director should have a post-graduate degree
in an appropriate medical or biological science. In addition, he/she must have a
reasonable experience of ART.
1.6 ART Procedures

A variety of ART procedures have been described in the literature. Only
those procedures that have been widely tested and proven to be satisfactory as of
writing this document are listed here. It would be the responsibility of the National
Accreditation Committee (Chapter 9) to ensure that the list given in this document
is enlarged in real time as progress occurs in the field. It is hoped that the
practitioners of ART in the country will bring to the notice of the Committee on a
continuing basis, any new procedure for the practice of which there would appear
to be a sound scientific case. The National Accreditation Committee or a body
appointed by it will approve or disapprove the new procedure within six months
of its having been made aware of in writing: if this is not done, the clinic could
continue to use the procedure until the above body has taken a decision on it. No
new procedure that has not been approved as above should be permitted to be
used by an infertility clinic for more than the period mentioned above.
One of the primary concerns of all ART treatments is the safety of the
patients and of their gametes and embryos which constitute the very beginning of
a new individual’s life. The basic tenets of any medical treatment mentioned in the
Helsinki Declaration of 1964 and reiterated in October 2000 in Scotland
(information available on the Internet) clearly spell out the ethical concerns of
treating patients. These basic tenets are also applicable to ART. The clinic must
ensure that a particular ART being offered is fully in consonance with the diagnosis
made of the cause of infertility. More particularly, the clinic must make sure that
patients are well informed about the treatment being offered to them, the reasons
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of suggesting a particular form of treatment, and alternative therapies available if
any.
If a clinic is offering an ART that is not listed in these guidelines now or
as modified in the future (vide para 1 of this Section), the procedure must be
approved by the clinics ethics committee (constituted as recommended by the
ICMR ethical guidelines, 2000), justifying the need for the procedure and explaining
why alternatives are not suitable. [Only clinics of Level 2 or Level 3 (Sections
2.5.3 and 2.5.4) would be required to have an ethics committee.] Informed
consent from the patients would be mandatory in such cases as well. As mentioned
in para one of this section, the clinic must also bring the new procedure to the
notice of the National Accreditation Committee for its approval; if such an approval
is not granted, all further use of the procedure must stop.
1.6.1 Artificial insemination with husband’s semen (AIH)
The technique consists in placing in the interior of the vagina a sample of
the unprocessed semen.
1.6.2 Artificial insemination with donor semen (AID)
The indications for AID are when there is (a) non-obstructive
azoospermia; (b) the husband has a hereditary genetic defect; or (c) when the
couples have Rh incompatibility.
The main advantage of AID is that it enables a couple to achieve
pregnancy even though the husband is not the biological father. However, the
possible transmission of diseases from the donor to the future child and the risk
of consanguinity, constitute some drawbacks that must be brought to the notice
of the patients. It is necessary to get the informed consent of both the partners
after they are counselled about the possible psychological conflict they may face
later in their life with the knowledge that one of them is not the biological parent of
their child.
AID is an ethically acceptable procedure provided there is a medical
indication and psychological confirmation for its use. Also, the normal
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conditions of anonymity and screening of the donor must be met and only frozen
sperm samples that have passed appropriate quarantining for infectious diseases
such as HIV, hepatitis B and C, and syphilis should be used (for details see Chapter
3). AID involves the placing of a donor’s semen into the interior of the vagina.
Common indications:
© Husband has non-obstructive azoospermia.
© Husband has a hereditary genetic defect.
© The couple has Rh incompatibility.
© The women is iso-immunized and has lost previous pregnancies and
intrauterine transfusion is not possible.
© Husband has severe oligozoospermia and the couple does not wish
to undergo any of the sophisticated ART such as ICSI.
1.6.3 Intrauterine insemination with either husband’s or

donor semen (IUI-H or IUI-D)
IUI involves the processing of semen in the laboratory so as to yield

pure, activated sperm, devoid of seminal plasma, which are then directly placed
into the uterus.
Common indications:
© Hostile uterine cervix that does not respond to medication. (Cervical
hostility can readily be determined by carrying out proper tests such
as the sperm-mucous interaction test or post-coital tests. Technical
skills constitute an important factor in carrying out these tests correctly
and reading the results.)
© In cases where husband’s sperm cannot be used for reasons as described
above for AID.
1.6.4 In vitro fertilization and embryo transfer (IVF-ET)
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The technique of IVF consists of bringing about the fertilization of

the oocyte and the spermatozoa in the laboratory instead of in the woman’s
fallopian tube. IVF involves induction of ovulation in order to obtain multiple
oocytes, thus making available more embryos with which higher pregnancy
rates can be achieved. Serial determination of plasma estradiol levels and
daily monitoring of ovarian follicular growth by ultrasonography would
indicate the response to ovarian stimulation. At the appropriate moment of
follicular growth, the follicles are aspirated to obtain the oocytes. The oocytes
are mixed with appropriately capacitated spermatozoa from the husband (or
the donor, if the medical condition indicates the use of donor sperm) and kept
in an incubator for fertilization which is observed microscopically after 16 to
18 hours. Embryos are transferred into the uterine cavity between days 2 and
6 after oocyte aspiration. If implantation ensues, pregnancy can be confirmed
by 14 to 16 days after embryo transfer by determining the presence of hCG in
a blood or urine sample. Such a test is reliable only when progesterone is
used for luteal supplementation instead of hCG.
The success rate of IVF is approximately one in every 4-5 women.

IVF is the therapeutic option of reproductive medicine with the highest yield
per attempt, coming close on many occasions to that achieved by fertile couples
conceiving naturally.
Common indications:
© The original indication for IVF was irreversible pathology of the

fallopian tubes, resulting from an inflammatory process or from
previous surgery. However, in recent years the indications for IVF include
infertility due to a subnormal male factor.
Other indications include:
© Idiopathic infertility.
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© Endometriosis.
© Infertility of immunological origin.
1.6.5 IVF-associated techniques

Gamete Intrafallopian Tube Transfer (GIFT) or Tubal Embryo
Transfer (TET) has been recommended for patients with undamaged fallopian
tubes. Access to the tube is gained by laparoscopy or by retrograde
catheterization through the uterine cervix. GIFT is associated with higher
levels of pregnancy than IVF but it has the drawback that it is unable to
demonstrate the fertilizing capacity of the gametes.
1.6.6 Intracytoplasmic sperm injection (ICSI) with
ejaculated, epididymal or testicular spermatozoa
It is well known that the incidence of fertilization with sub-optimal
semen is much lower in contrast to normal semen samples. It has been argued
that since a sizeable number of couples are not suitable for IVF because their
sperm count is far below 10 million/ml with less then 30% sperm being motile
and more than 30% having abnormal morphology, alternate methods must be
found to facilitate fertilization. Several approaches have been developed to
circumvent the barriers (the zona pellucida and the ooplasmic membrane)
that prevent the sperm reaching the ooplasm. Notable amongst these are:
partial zona dissection (PZD), subzonal insemination (SUZI), and
intracytoplasmic sperm injection (ICSI).
Live births have been reported using all these methods. The use of
PZD or SUZI must be discouraged, as they do not offer any distinct advantage.
ICSI is the most widely accepted choice of treatment for male factor infertility.
ICSI can be carried out with fresh or frozen-thawed ejaculated or epididymal/
testicular motile or live spermatozoa.
1.6.6.1 Indications of ICSI with ejaculated spermatozoa
• Severe male-factor infertility.
• Fertilization failure after standard IVF treatment.
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• Number of spermatozoa in the ejaculate too low for IVF.
1.6.6.2 Indications of ICSI with epididymal spermatozoa
obtained by microsurgical epididymal sperm aspiration
(MESA/PESA)
• Congenital bilateral absence of the vas deferens (CBAVD).
• Failed vasoepididymal anastomosis.
• Failed vasovasal anastomosis.
• Obstruction of both ejaculatory ducts.
• Anejaculation because of spinal cord injury.
• Retrograde ejaculation.
1.6.6.3 Indications of ICSI with testicular spermatozoa (TESA)

• Extensive scarring, rendering MESA/PESA impossible.
• Germ-cell hypoplasia (hypospermatogenesis).
• Germ-cell aplasia with focal spermatogenesis.
• Sertoli cell-only syndrome with focal spermatogenesis.
1.6.6.4 Indications of ICSI with in vitro matured oocytes

• Polycystic ovary.
• History of ovarian hyperstimulation.
1.6.7 Oocyte donation (OD) or embryo donation (ED)
Oocyte donation would necessitate using the husband’s semen for
fertilization and transferring the resultant embryo to the infertile female partner.
Embryo donation would obviate the necessity of using the husband’s semen.
The choice of oocytes and embryos for oocyte or embryo donation would
depend entirely on the circumstances prevalent at the time the infertile couple
comes for treatment, and the access of the infertility clinic to frozen oocytes
or embryos.
1.6.7.1 Indications for oocyte or embryo donation
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• Gonadal dysgenesis.
• Premature ovarian failure.
• Iatrogenic (due to ovarian surgery or radiation, or chemical
castration) ovarian failure.
• Women who have resistant ovary syndrome, or who are poor
responders to ovulation induction.
• Women who are carriers of recessive autosomal disorders.
• Women who have attained menopause.
Donors should be healthy (as determined by medical and
psychological examination, screening for STDs, and absence of HIV
antibodies) women in the age group of 18-35 years. Oocytes may be obtained
for donation, mostly by surgical intervention from women participating in an
IVF program, or those undergoing elective sterilization or surgery.
The recipient should be a healthy woman (determined by medical
and psychological examination) having normal genitalia (as determined by
physical examination) and uterine cavity (as determined by hystero-
salpingography). In case of OD, the semen characteristics of the husband
must be determined to see if they are in conformity with those associated
with normal fertility. The blood group of the donor should be noted; the donor
should also be tested for antibodies to rubella, HIV, hepatitis, CMV, gonorrhea,
syphilis, chlamydia, mycoplasma and trichomonas.
Ovum/embryo donation can be carried out in menopausal women
with no surviving child and desiring to have a child. The endometrium of
menopausal women has the ability to respond to sex hormones and provide a
receptive environment for the implantation of an embryo.
Various protocols are now available to prepare the endometrium of
the recipient for OD or ED with estrogens and progestogens until the placenta
takes over the function of maintaining the gestation.
1.6.8 Cryopreservation
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Facilities for cryopreservation are an essential component of an ART
clinic as they are to be used under a variety of conditions such as those
described below.
1.6.8.1 Freezing semen
Men, who are likely to suffer from psychological stress at the time
of ovum pick-up or those who cannot be present at the time of ovum pick-up,
are recommended to have their semen frozen for use at the appropriate time.
One of the important reasons for freezing semen from donors is that any
donor semen has to be quarantined for six months. The safety of using frozen
sperm has been abundantly proven, both by experimental work and the actual
results in humans. Matters of concern are the donor’s health and the necessity
to avoid donors who are infected with venereal diseases, hepatitis B or C, or
HIV. One of the drawbacks of sperm freezing is an approximate 20 % loss in
motility after thawing. Donors whose semen is frozen for future use are
required to report to the semen bank six months after donation to be checked
for HIV, HBV or HCV infection/disease status.
1.6.8.2 Freezing embryos
Embryos are routinely cryopreserved to enable storage of

supernumerary embryos, as upto a maximum of only three embryos is allowed
for transfer to avoid the risk of multiple pregnancies. Embryo freezing is a
widespread routine procedure to increase cumulative pregnancy rates.
Human embryos can be successfully cryopreserved at any stage from
zygote to blastocyst, using 1, 2 propanediol (PROH) or dimethylsulfoxide
(DMSO) for zygotes and cleaved embryos and glycerol for blastocysts. The
formation of ice crystals is of concern during embryo freezing. Using
programmed, slow freezers reduces this problem considerably, and slow
cooling is the most widely employed method. Human embryos are known to
survive a simple ultra-rapid procedure of fast cooling but there is not much
data on the efficacy of these techniques when used routinely. Straws or
ampoules used for freezing embryos should be carefully and permanently
labeled for identification purpose.
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Patients should be fully informed before the treatment cycle on the
procedure of cryopreservation, the risks and, particularly, what is to be done
with their embryos if they do not use them. They should sign a consent form
concerning the agreement for embryo freezing as well as for the future use of
the embryos (also see Section 3.11).
When a serum supplementation is used in the preparation of freezing
and thawing solutions, one must carefully avoid any risk of viral transmission
to the embryo through the serum.
1.6.8.3 Oocyte cryopreservation
This procedure has been successfully used in cases where a large

number of immature oocytes have been retrieved during ovum-pick-up. The
oocyte can be thawed at a later date, matured in vitro and used for oocyte
donation or similar procedures either on the person from whom the oocytes
were retrieved or on other prospective recipients. However, the success rates
in terms of fertilization, pregnancy and live births with the use of cryopreserved
oocytes are not very encouraging. Much remains to be learnt on identifying
the optimal stage of oocyte development when cryopreservation would be of
value.
1.6.9 In vitro culture media
There has been a spurt of new media introduced for in vitro culture
of gametes and embryos. If one takes a close look at these media, they are
products that have evolved over the years. However, some manufacturers do
not give the exact composition of their media but merely state that for reasons
of patent protection or as trade secret they are constrained to give full details
of the composition of their media (J D Biggers, Reproductive Biomedicine
Online Vol. 1, No 3, 2000; also available on the world-wide web: rbmonline.
com).
This is an undesirable situation. Infertility clinics that deal with human
embryos and the future life of the products they create in the laboratory must
be privy to the knowledge about the media they use, if need be by signing an
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appropriate confidentiality agreement which would prohibit the clinic from using
or passing on the proprietary information provided by the manufactures of the
media to any other organisation that may commercially exploit this information.
When a serum supplementation has to be used in the preparation of
media, one must carefully avoid the risk of viral transmission to the embryo
through the serum.
1.6.10 The future ART technologies
Assisted reproductive technologies represent a rapidly progressing
area in modern biology. It would be the responsibility of the National
Accreditation Committee (Chapter 9) to ensure that this list of techniques is
kept updated in real time.
1.6.11 Caution, precautions and concerns about ART practice
1.6.11.1 Ovarian stimulation
It is important that ART procedures aimed to facilitate the bringing

together of oocytes and spermatozoa should occur when the oocyte is ready
to fertilize. Under normal conditions it is very difficult to predict when
ovulation will occur and whether the oocytes released will be fertilizable. It
is, therefore, a common practice to induce follicular development by
administering clomiphene citrate (CC) and or human menopausal gonadotropin
(hMG) prepared from menopausal urine, followed by human chorionic
gonadotropin (hCG) for the induction of ovulation just when the ovarian
follicle has ripened and grown to its optimal size as determined by
ultrasonography. Insemination can be carried out in vivo, or the oocyte
aspirated and subjected to in vitro fertilization or ICSI. The time of oocyte
maturation can be predicted by this method to facilitate carrying out the rest
of the ART procedure.
Ovarian stimulation should be carried out with the utmost caution
to avoid Ovarian Hyperstimulation Syndrome (OHSS). Basal blood levels of
FSH and LH should be estimated on day 1 or 2 of the menstrual cycle. LH
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levels twice as high as FSH are indicative of the woman having polycystic
ovaries; such women are prone to develop multiple follicles when stimulated
and also undergo OHSS. Oocytes aspirated from such ovaries usually fail to
fertilize. If such women are subjected to mild ovarian stimulation with CC, it
is important to carefully monitor their ovarian response ultrasonographically.
1.6.11.2 Indiscriminate use of ICSI
ICSI, one of the latest entrants to the field of ART, has been claimed
to be a panacea for severe male infertility. This technique has never undergone
critical evaluation in animal models before introducing it to treat human
infertility. There are, therefore, some genuine concerns in regard to the use of
ICSI; some of the fears underlying these concerns have come true ( S.
Oehninger and R. G. Gasolen: Should ICSI be the treatment of choice for all
cases of in vitro conception ? No, not in light of the scientific data. Human
Reproduction 17: 2337, 2002).
Although, ICSI has revolutionized the treatment for male infertility,
its widespread use has raised medical concerns about the transfer of genetic
defects to future generations. There is a higher than normal frequency of sex
chromosome abnormalities in children born of ICSI procedures compared
with the normal population (Science 281:651-652, 1988; Human Reproduction
13: 781-782,1998; Human Reproduction 16:115-120,2001; British Medical
Journal 327: 852, 2003; Fertility and Sterility 80: 851, 2003). Besides, infertile
men carrying Y chromosome microdeletions pass this defect to ICSI-born
sons (Fertility and Sterility 74:909-915, 2000). During ICSI, the process of
fertilization is dramatically changed. For example, there is no fertilization
occurring in vivo, and the physiological maturation of sperm, its selection
and penetration through oocyte investments, and its influence on embryonic spatial
patterning (Nature 409: 517-521,2001), are bypassed. Because ICSI bypasses
a part of the process of natural selection and certain early developmental
mechanisms, concerns are expressed on the possible reproductive health risk(s)
to the offspring.
In India, it is estimated that about 15% of married couples are sub-
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fertile or infertile. Treatment of male-factor infertility in the country has improved
dramatically with the introduction of ICSI, which is currently being practiced rather
extensively in various major ART clinics in the country. It is, however, extremely
important that this approach to treating male-factor infertility is carried out with
caution, in view of the possible risk of vertically transmitting defective
(spermatogenetic) fertility gene(s) to the male progeny, when the etiology of
infertility is genetic in origin (Human Reproduction 13:219-227,1998). Thus, ICSI
may fall below the general expectations of the Helsinki Declaration (WMA 1964
and 2000). ART clinics accredited under the present programme must therefore
take due note of the above before resorting to ICSI, and counsel the couple for
whom ICSI is being recommended, appropriately. Inspite of what has been said
above, in some case, ICSI may still be the preferred choice of treatment for
infertility.
1.6.11.3 Possible misuse of ART – sale of embryos and stem cells
There is a growing interest in embryonic stem cells because of their

potential use for developing spare organs or replacing defective tissues such
as parts of the brain destroyed due to Alzheimer’s disease, or pancreatic cells
in diabetic patients. The range of their potential use is limited only by one’s
imagination.
ART clinics are the only source of embryonic stem cells. Spare
embryos are either frozen or returned to the infertile couple for replacement
during a later cycle, or donated to another infertile couple, or discarded after
five years using a suitable protocol (Section 3.11).
Recently, the USA banned all federal support for embryonic stem
cell researches unless the laboratories could demonstrate that they had
developed embryonic stem lines before August 10, 2001. However, private funding
is allowed which encourages scientists in the USA to procure stem cells from
abroad. Germany has banned all research on embryos produced in that country
but permits the use of embryos brought from abroad.
The stand taken by the foreign governments on embryo research opens
up the possibility of embryos from developing countries that do not have
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appropriate national guidelines in this area, being commercially exploited and sold
to foreign countries. Therefore sale or transfer of human embryos or any part
thereof, or of gametes in any form and in any way – that is, directly or indirectly –
to any party outside the country must be prohibited. Within the country, such
embryos or gametes could be made available to bonafide researchers only as a
gift, with both parties (the donor and the donee) having no commercial transaction,
interest or intent.
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Chapter 2
Screening of Patients for ART: Selection

Criteria and Possible Complications
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2.1 Patient Selection
During last two decades, there has been a marked increase in patient
population in all infertility clinics the world over, but all infertility clinics may
not be sufficiently equipped with the latest technology and expertise essential
to offer the best possible help. Hence there is a need for patient selection, in
order to categorise them in specific groups and then refer them to different
levels of infertility care units for step-wise investigation and treatment.
Patient selection for referral and, finally, for ART should be based
on the findings of basic investigations on the cause of infertility. These
investigations should consist of the following.
2.1.1 Husband
© Physical examination, both systemic and local, to detect any problem
that might be the cause of infertility or that may modify the management
of infertility.
© Semen analysis including both morphological and functional tests; if
any abnormality is detected, repeat tests should be done after suitable
intervals. An abnormal finding on a repeat semen examination warrants
full-scale investigation by an appropriate specialist to ascertain the
cause and then institute the necessary treatment.
© Screening for infections including syphilis, HBV, HCV and HIV, and
their appropriate management.
© If needed, appropriate endocrinological investigations and therapy.
2.1.2 Wife
© Physical examination, both systemic and local, to detect any problem
that might be the cause of infertility or that may modify the management
of infertility.
© Detection and timing of ovulation by basal body temperature (BBT),
cervical mucus studies, ultrasonography, premenstrual endometrial
biopsy, histopathological examination and serum progesterone
estimation in the mid-luteal phase.
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© Assessment of tubal patency by appropriate investigations including
hysterosalpingography, sonosalpingography, or laparoscopy if required,
to find out/rule out specific problems and to select the appropriate therapy.
© Screening for local factors including cervical mucus-related problems
and lower genital tract infections, and instituting appropriate therapy.
© Assessment of uterine cavity by hysteroscopy.
© Screening for reproductive tract infections including syphilis,
chlamydia, tuberculosis, HBV, HCV and HIV, and appropriate
management.
© If needed, appropriate endocrinological investigations and therapy.
Any gynaecologist not specifically trained in the subspeciality of
infertility care can also complete these investigations.
Based on the results of these investigations, couples should be
selected for treatment at different levels of infertility care units. Depending
on the personnel competence and availability of facilities for investigation
and treatment, there should be three levels of infertility care units: (a) primary
infertility care units, (b) secondary infertility care units, and (c) tertiary
infertility care units. These care units should work in a tier system.
2.2 Patient Selection for Treatment in Different

Infertility Care Units
In general, infertile couples can be categorized broadly into three
groups: (1) those with single defect in one of the partners; (2) those with
multiple defects in one or both the partners; (3) no apparent defect in either
partner (unexplained infertility).
2.2.1 Single defect in one of the partner
The fault may exist either in the male or in the female partner. The
defect may be either treatable or untreatable. For example, in the female
partner, a treatable defect could be tough or imperforate hymen, or oligo- or
anovulation due to polycystic ovary syndrome or a sub-mucous fibroid. The
untreatable female partner defects would include premature ovarian failure,
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absence of uterus, dense pelvic adhesions due to endometriosis, tuberculosis,
and pelvic inflammatory disease as a sequel to pelvic surgery.
Unlike female factor infertility, male factor infertility is seldom easily
correctable. Except oligozoospermia without asthenospermia, and sexual
dysfunction due to phimosis, no other male factor infertility is amenable to
simple medical or surgical therapy.
If a single defect in one of the partners is correctable, approximately
half of the patients will respond to conventional medical or surgical therapy
and the other half will not. Further treatment for the unresponsive couples
will then consist of counselling and an in-depth investigation, leading to the
use of ART – failing which, adoption may be the only alternative.
For an uncorrectable single defect, either in the male or in the female
partner, the choice would be between ART and adoption. The alternative to
be chosen should be suggested by the counsellor after evaluation of the age,
financial capabilities and psychological attitude of the couple.
2.2.2 Multiple defects in one or both partners
When multiple defects involve either one or both partners, attempt
to correct these defects and hoping to achieve a pregnancy in the natural way
is almost always unrewarding. This should be explained by the consulting
gynaecologist/physician to the couple to prevent unnecessary expenditure by
the couple. Judicious and effective counselling plays a very vital role under
such circumstances; at least some couples will accept that at this point their
treatment ends. A few will opt for adoption while others might wish to try the
challenges of ART procedures.
2.2.3 No detectable defect in either partner (unexplained or
idiopathic infertility)
This is a group most difficult to deal with as, they would have a
right to ask that, in spite of everything being normal, what is standing in their
way to achieve conception.
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The approach to management protocol of infertile couples with regard
to nature of defects may be summarized as follows:
OUTLINE OF MANAGEMENT PROTOCOL OF INFERTILE COUPLE:
INVESTIGATION
SINGLE DEFECT MULTIPLE DEFECTS NO DETECTABLE DEFECT
EASILY NOT EASILY

CORRECTABLE CORRECTABLE FURTHER SUPER
INVESTIGATIONS OVULATION
PREGNANCY NO PREGNANCY PREGNANCY NO PREGNANCY
ART ADOPTION
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2.3 Selection Criteria for ART
The choice of the procedure used, e.g. IVF-ET, GIFT, ZIFT, or ICSI,
is made depending upon the needs, resources and circumstances of the couple,
availability of the facilities, and experience and expertise of the gynaecologist/
embryologist. This section should be read in conjunction with Section 1.6.
2.3.1 Selection criteria for in vitro fertilization and

embryo transfer (IVF-ET)
2.3.1.1 Tubal disease
IVF-ET can be offered where microsurgical techniques for tubal and

peritoneal disease have failed or are unlikely to benefit the patient. The
presence of peritubal adhesions, condition of the tubal wall, condition of the
ciliary epithelium and degree of fimbrial damage would dictate the choice
between IVF and microsurgery. Patients who have already undergone
tuboplasty and those with inaccessible ovaries would be more suitable for
IVF. In cases of history of ectopic pregnancy, IVF would be a better option.
2.3.1.2 Endometriosis
IVF is a suitable option for (a) women with moderate to severe

endometriosis; (b) those in whom medical or surgical therapy has failed; and
(c) sometimes in cases of mild to moderate endometriosis in the presence of
other factors contributing to infertility.
2.3.1.3 Unexplained infertility
Couples who have prolonged unexplained infertility would benefit

from IVF, as many factors such as subtle ovulation defects, defects in ovum
pick-up, gamete transport, tubal environment, sperm abnormality, or oocyte
abnormality may come to light when IVF is used.
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2.3.1.4 Immunological factor
IVF can be used when there are antisperm antibodies either in the male
or the female and when other techniques such as immunosuppression, use of
condoms, intrauterine insemination and other therapeutic measures have failed.
2.3.1.5 Cervical factor
IVF can be offered for cervical factor only if repeated attempts (6 to 8

cycles) of intrauterine insemination have failed and other therapies have not resulted
in pregnancy.
2.3.1.6 Male factor
IVF-ET is the logical therapy in cases of low concentrations of sperm

(say, less than 10 million/ml), low motility (less than 30%), and/or abnormal
sperm morphology (presence of > 60% abnormal forms). No universally
accepted minimal sperm concentration for success in IVF exists. In cases of
severe male factor infertility, assisted fertilization by means of
micromanipulation and sperm injection (ICSI) can be offered even in
obstructive and non-obstructive cases. In severe oligozoospermia,
teratozoospermia, cryptozoospermia and azoospermia (obstructive/
nonobstructive), ICSI can be employed using either ejaculated or epididiymal
sperm.
2.3.1.7 Ovarian disorders
IVF-ET can benefit patients with hypogonadotropic anovulation,

oligoovulation, and luteal phase deficiency, although IVF is rarely indicated
when these disorders exist as isolated conditions. IVF-ET can be used for
women with luteinized unruptured follicle syndrome in polycystic ovarian
disease.
2.3.1.8 Uterine disorders
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Patients with Mullerian agenesis or congenital uterine anomalies, women
with severe intrauterine adhesion refractory to surgical lysis of the adhesions, and
hysterectomized patients can, through IVF, transfer their embryos to a surrogate
mother.
2.3.1.9 In association with donor oocytes and donor embryos
Women who have undergone premature or timely menopause and women

in the perimenopausal age group who do not show proper recruitment of follicles
and who have other existing causes of infertility, can avail of the option of donor
oocytes and donor embryos. Women with genetic disorders, those who have
undergone radiation therapy, and those with ovaries that are not accessible by
ultrasound due to severe adhesions, can also be advised to avail of donor oocytes
for IVF-ET.
2.3.2 Selection criteria for gamete intra-fallopian transfer
(GIFT)
The experimental background for GIFT is the ability of the fallopian
tube to serve as the site for capacitation and fertilization in human beings.
Earlier experiments using GIFT were carried out on monkeys that had
undergone tubal resection and ligation. In 1979, Shettles reported pregnancy
after intratubal transfer of freshly aspirated oocytes at the time of tubal re-
anastomosis combined with cervical insemination. Asch and colleagues (1987)
reported the first pregnancy and birth using laparoscopic GIFT. The
indications for GIFT are almost similar to that for IVF-ET, except that GIFT
cannot be performed on those who have both the fallopian tubes blocked.
2.3.3 Choosing between IVF-ET and GIFT
Decision in regard to which of these techniques should be utilized,
must be individualized for each patient. The advantages of IVF over GIFT
are documentation of fertilization, less trauma and relatively lower anaesthetic
risk. There is no exposure to excess quantities of carbon dioxide in IVF as happens
during laparoscopic insufflation with GIFT. On the other hand, GIFT is more
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natural as fertilization occurs in the tubal ampulla, the gametes are minimally exposed
in vitro, and early embryo development occurs in a natural environment.
2.3.4 Micro-assisted fertilization (SUZI and ICSI)
Subzonal insemination (SUZI), intracytoplasmic sperm injection (ICSI)
and assisted hatching need micromanupulation of gametes. SUZI involves sperm
injection in in vitro, in-to the sub zonal space of oocytes. This technique has now
been virtually totally replaced by ICSI, which involves injection of sperm into the
cytoplasm of the oocyte and which is useful in a variety of cases such as aging
ova, elderly women, repeated failure of implantation in IVF, and in certain cases
of male factor infertility. Assisted hatching of embryo by drilling a hole in the zona
pellucida is resorted prior to embryo transfer for improving implantation rates.
2.4 Complications
ART procedures carry a small risk both to the mother and the offspring.
These risks must be explained to the couple and appropriate counselling done.
ART procedures are to be initiated only after patients understand these risks and
still want to undergo ART. Some of the most commonly encountered risks are
mentioned below (this list is not exhaustive).
2.4.1 Multiple gestation
The reported incidence of multiple gestation ranges from 20 to 30%.
Incidence of twin pregnancies in the range of 10-20% may have to be accepted
as inevitable, but specific efforts must be made to reduce the incidence of
triplets and multiple births of higher order. Therefore, not more than three
oocytes should be transferred for GIFT and not more than three embryos for
IVF-ET at one sitting, excepting under exceptional circumstances (such as
elderly women, poor implantation, advanced endometriosis or poor embryo
quality; also see Section 3.5.13) which should be recorded; the remaining embryos,
if any, may be cryopreserved and, if required, transferred at a later cycle.
2.4.2 Ectopic pregnancy
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Ectopic pregnancy rates could be as high as up to 8% for ART
procedures. The choice of an appropriate procedure as per guidelines
mentioned earlier, especially in persons with tubal disease, may reduce the
chances of an ectopic pregnancy.
2.4.3 Spontaneous abortion
Spontaneous abortion rates range from 20 to 35%. Abortion rates
rise with increasing age of the mother and in multiple pregnancies, especially
with three or more foetuses. In cases where more than two foetuses are
present, selective embryo reduction should be advised. It is essential that the
advantages of embryo reduction (better chances of the survival of other
foetuses and the fact that they are likely to be born nearer term and with
better birth weight) and disadvantages (the possibility that there might be an
increased risk of abortion following the procedure) must be explained to the
couple, and their informed consent taken before embryo reduction is attempted.
2.4.4 Preterm birth
There is a higher risk of premature/low birth weight delivery
following ART, especially in the presence of multiple foetuses.
2.4.5 Ovarian hyperstimulation syndrome
The use of superovulation for ART entails a risk of hyperstimulation
in some women, in the range of 0.2 to 8.0%. The extent of this risk is
determined by the hormonal profile of the woman, the estradiol values (greater
than 2500 pg/ml), the dose required for triggering ovulation, the ability to
aspirate all the follicles at the time of oocyte retrieval, and several other factors.
The programme director should be fully aware of the means to avoid
hyperstimulation and also its treatment. Careful monitoring and management will
reduce this risk as well as the morbidity associated with it.
In addition to these specific complications of ART, couples undergoing
various ART procedures incur the risks associated with the operative and
anaesthetic procedures involved in ART.
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2.5 Categories of Infertility Care Units
The severity in the cause of infertility varies between couples. Sometimes,
simple counselling or minor intervention will be all that is necessary. Others may
require more aggressive treatment; such cases should be referred to speciality
clinics. It is, therefore, recommended that infertility treatment should be offered at
four levels. The infertility care units should be categorized into the four levels and
authorized to offer treatments as described below. Patients should be referred by
their gynaecologist or physician to whom they go first, if necessary, to the specific
level of infertility care unit where appropriate facilities for investigation and treatment
for that patient would be available. Level 1B, Level 2 and level 3 infertility clinics
may encourage appropriately qualified gynaecologists of Level 1A clinics to use
their facilities, provided the clinic thus being used by a gynaecologist takes the
responsibility of ensuring that all norms stated in this document - including the
maintenance of records - are followed.
2.5.1 Primary (Level 1A) infertility care units
These would be clinics where preliminary investigations are carried out
and type and cause of infertility diagnosed. Primary infertility care unit or clinic
could be a doctor’s consulting room, such as a gynaecologist’s or a physician’s
consulting room, or even a general hospital. Depending on the severity of infertility,
the couple could be treated at the Level 1A clinic or referred to a speciality (Level
1B, Level 2 or Level 3) clinic.
Investigations into the cause of infertility by diligent history taking, physical
examination and a simple semen analysis that can detect cases of azoospermia,
can determine if the cause of infertility is related to the female or the male or to
both the partners. Multifactorial or unexplainable cases should be referred to
speciality secondary (Level 2) or tertiary (Level 3) infertility care units.
The gynaecologist or the physician in charge of a Level 1A infertility
care unit should have an appropriate post-graduate degree and be capable of
taking care of the above responsibilities.
The responsibilities of a Level 1A primary infertility care unit would be
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1. Completion of the basic investigations mentioned above.
2. Treatment of minor anatomical defects like tough imperforate hymen.
(Surgical perforation of hymen can be carried out after ensuring that
the husband does not have erectile dysfunction. Extreme care must
be taken in performing hymenectomy).
3. Treatment of mild endometriosis after confirming its presence by
diagnostic laparoscopy carried out by a competent surgeon with
adequate endoscopic experience.
4. Introduction of ovulation in non-ovulatory women (especially PCOS)
with clomiphene citrate, with or without adjuncts like bromocriptine,
eltroxin, dexamethasone or spironolactone. (Gonadotropin should
not be used at a primary infertility care unit level).
5. Correcting minor endocrine disorders such as thyroid disorders or
hyperprolactinemia, by prescribing appropriate corrective
medications.
6. Treatment of oligozoospermia without asthenozoospermia.
7. Detecting infection of the reproductive tract using appropriate
diagnostic tests, followed by normal health-care steps after carrying
out appropriate antibiotic sensitivity tests. (Particular care must be
taken to treat the couple and not the female or the male patient
alone).
8. Ability to carry out AIH.
9. Ability to carry out IUI using processed semen of husband or donor
obtained from an accredited laboratory or semen bank which must
maintain a record ( as in section 3.3.7 ) of complete details including
the name, qualification and complete address of the gynaecologist/
clinic requesting the processed semen and carrying out the IUI.
10. Referral of the couple to Level 1B, Level 2 or Level 3 infertility
care unit as appropriate, specially when the woman’s age is more
than 35, or when the couple has a multifactorial defect, or when
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patients with single treatable defect have not responded to conventional
therapy.
The gynaecologist or the physician in charge of a Level 1A infertility

care unit should have an appropriate post-graduate degree or diploma, and
be capable of taking care of the above responsibility. In case a Level 1A clinic
is engaged in AIH and IUI it must maintain records (as in section 3.3.7) of
the use of the requisitioned semen and of all AIH & IUI done, appropriately
and confidentially; these records will be liable to inspection by an appropriate
Review Committee (section 3.15). A Level 1A infertility care unit will not
require an accreditation under these guidelines.
2.5.2 Primary (Level 1B) infertility care units engaging in
IUI
These units would be required to have, in addition to what has been
stated in Section 2.5.1, the facilities mentioned in the following two sub-
sections (2.5.2.1 and 2.5.2.2). Infertility clinics falling into this category [like
those of Level 2 and Level 3 (see the following sections)] shall need
accreditation. The IUI in such clinics must be done under the supervision of
a gynaecologist with a post-graduate degree.
2.5.2.1 Facilities for investigations:
i. Immunological tests for infertility, sperm cervical mucous
penetration test (SCMPT), sperm cervical mucous test
(SCMT), and test for antibodies (IgG, IgA) against sperm
antigen in cervical mucous.
ii. Sperm function tests like hypo-osmotic swelling test (HOST),
and assessment for improvement of sperm motility potential
with pentoxifyllene co-culture.
iii. Assessment of follicular growth and ovulation by serial
transvaginal sonography (TVS).
iv. Hysteroscopy, laparoscopy and transvaginal sonography.
2.5.2.2 Treatment facilities:
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i. Facilities for semen preparation and certification and for intrauterine
insemination (IUI), including an appropriate sterile area for IUI.
(The facilities for investigation and for sperm preparation mentioned
above could be shared with another accredited infertility clinic or
semen bank).
2.5.3 Secondary (Level 2) infertility care units
These units must have infrastructure for further in-depth investigation
and extended treatment of infertility except where oocytes are handled outside
the body. Some of the investigations and treatment facilities required for
Level 2 care units are detailed below:
2.5.3.1 Facilities for investigations:
i. Immunological tests for infertility, sperm cervical mucous
penetration test (SCMPT), sperm cervical mucous test
(SCMT), and tests for antibodies (IgG, IgA) against sperm
antigen in cervical mucous.
ii. Sperm function tests like hypo-osmotic swelling test (HOST),
and assessment of the improvement of sperm motility potential
with pentoxifyllene co-culture.
iii. Assessment of follicular growth and ovulation by serial
transvaginal sonography (TVS).
iv. Hysteroscopy, laparoscopy and transvaginal sonography.
2.5.3.2 Treatment facilities:
i. Facilities for semen preparation and intrauterine insemination (IUI).
ii. Provision for semen collection in men with a vibrator or an
electroejaculator in functional erectile and ejaculatory problems.
iii. Conservative surgery either through a laparoscope,
hysteroscope or via laparotomy. It should be possible to perform
hysteroscopic cannulation of blocked tubes, and resection of
submucous myoma or uterine septum.
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iv. Combined medical-surgical therapy by a co-ordinated team as in
endometriosis or in some cases of polycystic ovaries (ovarian
drilling).
v. Provision for extended treatment of infertility except for oocyte
pick up and IVF, ICSI etc.
2.5.4 Tertiary (Level 3) infertility care units
Such units will have three functions to perform, viz. diagnostic and
therapeutic at the highest level of specialization and with the best of facilities,
and research. Some examples of the first two functions are given below in
Sections 2.5.4.1 to 2.5.4.3. If any of the facilities mentioned below does not
exist in the clinic, the clinic should have access to such a facility in another
appropriately accredited clinic, semen bank, or laboratory.
2.5.4.1 Diagnostic procedures for male infertility
i. Endocrine assay.
ii. Further tests for sperm function and integrity such as acrosome
reaction and sperm-oocyte interaction in vitro.
iii. Assessment of cell contaminants, debris and infection.
iv. Karyotyping when sperm density, morphology and motility are
abnormal.
v. Assessment of seminal plasma for viscosity, thinness, blood
contamination and biochemical constituents.
2.5.4.2 Diagnostic procedures for female infertility
i. Endocrine assay.
ii. Karyotyping in premature ovarian failure in Kallman’s
syndrome.
iii. Colour Doppler for checking growing follicles, functional
integrity of corpus luteum, and developing endometrium in
stimulated or unstimulated cycle.
iv. GnRH challenge test in non-ovulation due to hypothalamic
pituitary failure.
v. Clomiphene challenge tests to ascertain ovarian reserves before
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ovulation induction or controlled ovarian hyperstimulation.
2.5.4.3 Therapeutic procedures
i. Induction of ovulation in refractory non-ovulation due to PCO-
down regulation with a GnRH-agonist followed by induction
with gonadotropin.
ii. All varieties of assisted reproductive technologies, including
ICSI, mentioned earlier.
iii. Procedures for IUI using split ejaculate, pooled ejaculate or
sperm recovered from post-coital specimen of urine in
retrograde ejaculation.
iv. Embryo freezing.
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Chapter 3
Code of Practice,
Ethical Considerations and Legal Issues
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3.1 Clinics which should be Registered
Clinics involved in any one of the following activities should be regulated,
registered and supervised by the State Accreditation Authority/State Appropriate
Authorities (Section 3.15).
1. Any treatment involving the use of gametes which have been donated
or collected or processed in vitro, except for AIH, and for IUI by
level 1A clinics who will not process the gametes themselves.
2. Any infertility treatment that involves the use and creation of embryos
outside the body.
3. The processing or /and storage of gametes or embryos.
4. Research on human embryos.
The term ART clinic used in this document refers to a clinic involved in
any one of the first three of the above activities.
3.2 Code of Practice

This Code of Practice deals with all aspects of the treatment provided
and the research done at registered clinics. Those areas which most affect the
doctors, scientists and patients and are a part of this code are summarized below.
3.2.1 Staff: A ‘person responsible’ shall take full responsibility for ensuring that
the staff of the registered unit is sufficiently qualified, that proper
equipment is used, that genetic material is kept and disposed off properly,
and that the center complies with the conditions of its registeration.
Guidelines for minimum standards and qualifications of clinical,
scientific and counselling staffs are laid down in Chapter 1. Failure of
the ‘person responsible’ to comply with the mandatory code of practice
can lead to his/her removal or prosecution, or to the suspension of the
clinic’s registration.
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3.2.2 Facilities: These must cover the standards expected in respect of provision
of clinical, laboratory and counselling care mentioned in Chapters 1 and
2. Proper systems for monitoring and assessing practices and procedures
are required to be in place (for example in the form of Standard Operating
Procedures) in order to optimize the outcome of ART.
3.2.3 Confidentiality: Any information about clients and donors must be kept
confidential. No information about the treatment of couples provided
under a treatment agreement may be disclosed to anyone other than the
accreditation authority or persons covered by the registration, except
with the consent of the person(s) to whom the information relates, or in
a medical emergency concerning the patient, or a court order. It is the
above person’s right to decide what information will be passed on and
to whom, except in the case of a court order.
3.2.4 Information to patient: All relevant information must be given to the patient
before a treatment is given. Thus, before starting treatment, information
should be given to the patient on the limitations and results of the proposed
treatment, possible side-effects, the techniques involved, comparison
with other available treatments, the availability of counselling, the cost
of the treatment, the rights of the child born through ART, and the need
for the clinic to keep a register of the outcome of a treatment.
3.2.5 Consent: No treatment should be given without the written consent of the
couple to all the possible stages of that treatment, including the possible
freezing of supernumerary embryos. A standard consent form
recommended by the accreditation authority should be used by all ART
clinics. Specific consent must be obtained from couples who have their
gametes or embryos frozen, in regard to what should be done with them
if he/she dies, or becomes incapable of varying or revoking his or her
consent.
3.2.6 Counselling: People seeking registered treatment must be given a suitable
opportunity to receive proper counselling about the various implications
of the treatment. No one is obliged to accept counselling but it is generally
recognized as being beneficial, and couples should be encouraged to go
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through it. The provision of facilities for counselling in an ART clinic (of
Levels 1B, 2 or 3) is, therefore, mandatory. Couples should be referred
for support or therapeutic counselling as appropriate.
3.2.7 Use of gametes and embryos: No more than three oocytes or embryos
may be placed in a woman in any one cycle, regardless of the procedure/
s used, excepting under exceptional circumstances (such as elderly
women, poor implantation, adenomiosis, or poor embryo quality) which
should be recorded. No woman should be treated with gametes or
with embryos derived from the gametes of more than one man or woman
during any one-treatment cycle.
3.2.8 Storage and handling of gametes and embryos: The ‘highest possible
standards’ in the storage and handling of gametes and embryos in respect
of their security, and in regard to their recording and identification, should
be followed.
3.2.9 Research: The accreditation authority must approve all research that
involves embryos created in vitro. A separate registration should be
issued for each research project involving human embryos. The
accreditation authority must not give a registation certificate unless it is
satisfied that the use of human embryos is essential for the purposes of
the proposed research and the research is in public interest.
Additionally:
(i) No human embryo may be placed in a non-human animal
(ii) All research projects must be approved by the Institutional Ethics
Committee before submission to the accreditation authority.
3.2.10 Complaints: All registered ART clinics are required to have procedures
for acknowledging and investigating complaints, and to have a nominated
person to deal properly with such complaints. The accreditation authority
must be informed of the number of complaints made in any year and
those that are outstanding.
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3.3 Responsibilities of the Clinic
3.3.1 To give adequate information to the patients (detailed in Section 3.4).
3.3.2 To explain to the patient the rationale of choosing a particular treatment
(see Chapter 2) and indicate the choices the patient has (including the
cheapest possible course of treatment), with advantages and
disadvantages of each choice.
3.3.3 To help the patient exercise a choice, which may be best for him/her,
taking into account the individual’s circumstances.
3.3.4 To maintain records in an appropriate proforma (to be prescribed by
the authority) to enable collation by a national body.
3.3.5 When commercial DNA fingerprinting becomes available, to keep on its
record, if the ART clinic desires and couple agrees, DNA fingerprints of
the donor, the child, the couple and the surrogate mother should be
done.
3.3.6 To keep all information about donors, recipients and couples confidential
and secure. The information about the donor (including a copy of the
donor’s DNA fingerprint if available, but excluding information on the
name and address – that is, the individual’s personal identity) should be
released by the ART clinic after appropriate identification, only to the
offspring and only if asked by him/her after he/she reaches the age of 18
years, or as and when specified and required for legal purposes, and
never to the parents (excepting when directed by a court of law).
3.3.7 To maintain appropriate, detailed record of all donor oocytes, sperm or
embryos used, the manner of their use (e.g. the technique in which they
are used, and the individual/couple/surrogate mother on whom they are
used). These records must be maintained for at least ten years after
which the records must be transferred to a central depository to be
maintained by the ICMR. If the ART clinic/centre is wound up during
this period, the records must be transferred to the central repository in
the ICMR.
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3.3.8 To have the schedule of all its charges suitably displayed in the clinic and
made known to the patient at the beginning of the treatment. There must
be no extra charges beyond what was intimated to the patient at the
beginning of the treatment.
3.3.9 To ensure that no technique is used on a patient for which demonstrated
expertise does not exist with the staff of the clinic.
3.3.10 To be totally transparent in all its operations. The ART clinics must,
therefore, let the patient know what the success rates of the clinic are in
regard to the procedures intended to be used on the patient.
3.3.11 To have all consent forms available in English and local language(s).
3.4 Information and Counselling to be given to

Patients
Information must be given to couples seeking treatment, on the following
points:
3.4.1. The basis, limitations and possible outcome of the treatment proposed,
variations in its effectiveness over time, including the success rates with
the recommended treatments obtained in the clinic as well as around the
world (this data should be available as a document with references, and
updated every 6 – 12 months).
3.4.2. The possible side-effects (e.g. of the drug used) and the risks of treatment
to the women and the resulting child, including (where relevant) the risks
associated with multiple pregnancy.
3.4.3 The need to reduce the number of viable foetuses, in order to ensure the
survival of at least two foetuses.
3.4.4. Possible disruption of the patient’s domestic life which the treatment
may cause.
3.4.5 The techniques involved, including (where relevant) the possible
deterioration of gametes or embryos associated with storage, and
possible pain and discomfort.
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3.4.6 The cost (with suitable break-up) to the patient of the treatment proposed
and of an alternative treatment, if any (there must be no other “hidden
costs”).
3.4.7 The importance of informing the clinic of the result of the pregnancy in a
pre-paid envelope.
3.4.8 To make the couple aware, if relevant, that a child born through ART
has a right to seek information (including a copy of the DNA fingerprint,
if available) about his genetic parent/surrogate mother on reaching 18
years, excepting information on the name and address – that is, the
individual’s personal identity – of the gamete donor or the surrogate
mother. The couple is not obliged to provide the information to which
the child has a right, on their own to the child when he/ she reaches the
age of 18, but no attempt must be made by the couple to hide this
information from the child should an occasion arise when this issue
becomes important for the child.
3.4.9 The advantages and disadvantages of continuing treatment after a certain
number of attempts.
Pamphlets (one-page on each technique in all local languages and English)

which give clear, precise and honest information about the procedure recommended
to be used will help the couple make an informed choice.
3.5 Desirable Practices/Prohibited Scenarios

3.5.1 A third party donor of sperm or oocytes must be informed that the
offspring will not know his/her identity. He/She must also be informed of
the provisions in Section 3.4.8.
3.5.2 There would be no bar to the use of ART by a single women who wishes
to have a child, and no ART clinic may refuse to offer its services to the
above, provided other criteria mentioned in this document are satisfied.
The child thus born will have all the legal rights on the woman or the
man.
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3.5.3 The ART clinic must not be a party to any commercial element in donor
programmes or in gestational surrogacy.
3.5.4 A surrogate mother carrying a child biologically unrelated to her must
register as a patient in her own name. While registering she must mention
that she is a surrogate mother and provide all the necessary information
about the genetic parents such as names, addresses, etc. She must not
use/register in the name of the person for whom she is carrying the child,
as this would pose legal issues, particularly in the untoward event of
maternal death (in whose names will the hospital certify this death?).
The birth certificate shall be in the name of the genetic parents. The
clinic, however, must also provide a certificate to the genetic parents
giving the name and address of the surrogate mother. All the expenses
of the surrogate mother during the period of pregnancy and post-natal
care relating to pregnancy should be borne by the couple seeking
surrogacy. The surrogate mother would also be entitled to a monetary
compensation from the couple for agreeing to act as a surrogate; the
exact value of this compensation should be decided by discussion
between the couple and the proposed surrogate mother. An oocyte donor
can not act as a surrogate mother for the couple to whom the ooctye is
being donated.
3.5.5 A third-party donor and a surrogate mother must relinquish in writing all
parental rights concerning the offspring and vice versa.
3.5.6 No ART procedure shall be done without the spouse’s consent.
3.5.7 The provision or otherwise of AIH or ART to an HIV-positive woman
would be governed by the implications of the decision of the Supreme
Court in the case of X – vs – Hospital 2 (1998) 8 Sec. 269 or any other
relevant judgement of the Supreme Court, or law of the country, whichever
is the latest.
3.5.8 Gametes produced by a person under the age of 21 shall not be used.
The accepted age for a sperm donor shall be between 21 and 45 years
and for the donor woman between 18 and 35 years.
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3.5.9 Sex selection at any stage after fertilization, or abortion of foetus of any
particular sex should not be permitted, except to avoid the risk of
transmission of a genetic abnormality assessed through genetic testing
of biological parents or through preimplantation genetic diagnosis (PGD).
3.5.10 No ART clinic shall offer to provide a couple with a child of the desired
sex.
3.5.11 Collection of gametes from a dying person will only be permitted if the
widow wishes to have a child.
3.5.12 No more than three eggs or embryos should be placed in a woman
during any one treatment cycle, regardless of the procedure used,
excepting under exceptional circumstances {such as elderly women
(above 37 years), poor implantation (more than three previous failures),
advanced endometriosis, or poor embryo quality} which should be
recorded.
3.5.13 Use of sperm donated by a relative or a known friend of either the wife
or the husband shall not be permitted. It will be the responsibility of the
ART clinic to obtain sperm from appropriate banks; neither the clinic
nor the couple shall have the right to know the donor identity and address,
but both the clinic and the couple, however, shall have the right to have
the fullest possible information from the semen bank on the donor such
as height, weight, skin colour, educational qualification, profession, family
background, freedom from any known diseases or carrier status (such
as hepatitis B or AIDS), ethnic origin, and the DNA fingerprint (if
possible), before accepting the donor semen. It will be the responsibility
of the semen bank and the clinic to ensure that the couple does not
come to know the identity of the donor. The ART clinic will be authorized
to appropriately charge the couple for the semen provided and the tests
done on the donor semen.
3.5.14 What has been said above under 3.5.13 also would be true of oocyte
donation.
3.5.15 When DNA fingerprinting technology becomes commercially available,
the ART clinic may offer to the couple, a DNA fingerprint of the donor
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without revealing his/her identity, against appropriate payment towards
the cost of the DNA fingerprint. An ART clinic will then have DNA
fingerprinting done of the couple and keep the DNA fingerprints on its
records.
3.5.16 Trans-species fertilization involving gametes of two species is prohibited.
3.5.17 Ova derived from foetuses cannot be used for IVF but may be used for
research.
3.5.18 Semen from two individuals must never be mixed before use, under any
circumstance.
3.5.19 Transfer of human embryo into a human male or into any animal belonging
to any other species, must never be done and is prohibited.
3.5.20 The data of every accredited ART clinic must be accessible to an
appropriate authority of the ICMR for collation at the national level.
3.5.21 Any publication or report resulting out of analysis of such data by the
ICMR will have the concerned members of the staff of the ART clinic as
co-authors.
3.5.22 The consent on the consent form must be a true informed consent
witnessed by a person who is in no way associated with the clinic.
3.6 Requirements for a Sperm Donor

3.6.1 The individual must be free of HIV and hepatitis B and C infections,
hypertension, diabetes, sexually transmitted diseases, and identifiable
and common genetic disorders such as thalassemia.
3.6.2 The age of the donor must not be below 21 or above 45 years.
3.6.3 An analysis must be carried out on the semen of the individual, preferably
using a semen analyzer, and the semen must be found to be normal
according to WHO method manual for semen analysis, if intended to be
used for ART.
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3.6.4 The blood group and the Rh status of the individual must be determined
and placed on record.
3.6.5 Other relevant information in respect of the donor, such as height, weight,
age, educational qualifications, profession, colour of the skin and the
eyes, record of major diseases including any psychiatric disorder, and
the family background in respect of history of any familial disorder, must
be recorded in an appropriate proforma.
3.7 Requirements for an Oocyte Donor

3.7.1 The individual must be free of HIV and hepatitis B and C infections,
hypertension, diabetes, sexually transmitted diseases, and identifiable
and common genetic disorders such as thalassemia.
3.7.2 The blood group and the Rh status of the individual must be determined
and placed on record.
3.7.3 Other relevant information in respect of the donor, such as height, weight,
age, educational qualifications, profession, colour of the skin and the
eyes, and the family background in respect of history of any familial
disorder, must be recorded in an appropriate proforma.
3.7.4 The age of the donor must not be less than 21 or more than 35 years.
3.8 Requirements for a Surrogate Mother

See Section 3.10.
3.9 How may Sperm and Oocyte Donors and

Surrogate Mothers be Sourced?
3.9.1 Semen banks
3.9.1.1 Either an ART clinic or a law firm or any other suitable independent
organization may set up a semen bank. If set up by an ART clinic it must
operate as a separate identity.
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3.9.1.2 The bank will ensure that all criteria mentioned in Section 3.6
(Requirements for a sperm donor) are met and a suitable record of all
donors is kept for 10 years after which, or if the bank is wound up
during this period, the records shall be transferred to an ICMR repository.
3.9.1.3 A bank may advertise suitably for semen donors who may be
appropriately compensated financially.
3.9.1.4 On request for semen by an ART clinic, the bank will provide the clinic
with a list of donors (without the name or the address but with a code
number) giving all relevant details such as those mentioned in Section
3.6. The semen bank shall not supply semen of one donor for more
than ten successful pregnancies. It will be the responsibility of the ART
clinic or the patient, as appropriate, to inform the bank about a successful
pregnancy. The bank shall keep a record of all semen received, stored
and supplied, and details of the use of the semen of each donor. This
record will be liable to be reviewed by the accreditation authority.
3.9.1.5 The bank must be run professionally and must have facilities for
cryopreservation of semen, following internationally accepted protocols.
Each bank will prepare its own SOP (Standard Operating Procedures)
for cryopreservation.
3.9.1.6 Semen samples must be cryopreserved for at least six months before
first use, at which time the semen donor must be tested for HIV and
hepatitis B and C.
3.9.1.7 The bank must ensure confidentiality in regard to the identity of the semen
donor.
3.9.1.8 A semen bank may store a semen preparation for exclusive use on the
donor’s wife or on any other woman designated by the donor. An
appropriate charge may be levied by the bank for the storage. In the
case of non-payment of the charges when the donor is alive, the bank
would have the right to destroy the semen sample or give it to a bonafide
organisation to be used only for research purposes. In the case of the
death of the donor, the semen would become the property of the legal
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heir or the nominee of the donor at the time the donor gives the sample
for storage to the bank. All other conditions that apply to the donor
would now apply to the legal heir, excepting that he cannot use it for
having a woman of his choice inseminated by it. If after the death of the
donor, there are no claimants, the bank would have the right to destroy
the semen or give it to a bonafide research organisation to be used only
for research purposes.
3.9.1.9 All semen banks will require accreditation.
3.9.2. Sourcing of oocytes and surrogate mothers

Law firms and semen banks will be encouraged to obtain (for example,
through appropriate advertisement) and maintain information on possible oocyte
donors and surrogate mothers as per details mentioned elsewhere in this document.
The above organizations may appropriately charge the couple for providing an
oocyte or a surrogate mother. The oocyte donor may be compensated suitably
(e.g. financially) by the law firm or semen bank when the oocyte is donated.
However, negotiations between a couple and the surrogate mother must be
conducted independently between them.
3.9.3. Oocyte sharing
The system of oocyte sharing in which an indigent infertile couple that
needs to raise resources for ART agrees to donate oocytes to an affluent infertile
couple wherein the wife can carry a pregnancy through but cannot produce her
own oocyte, for in-vitro fertilization with the sperm of the male partner of the
affluent couple, for a monitory compensation that would take care of the expenses
of an ART procedure on the indigent couple, must be encouraged.
3.10 Surrogacy: General Considerations

3.10.1 A child born through surrogacy must be adopted by the genetic
(biological) parents unless they can establish through genetic (DNA)
fingerprinting (of which the records will be maintained in the clinic) that
the child is theirs.
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3.10.2 Surrogacy by assisted conception should normally be considered only
for patients for whom it would be physically or medically impossible/
undesirable to carry a baby to term.
3.10.3 Payments to surrogate mothers should cover all genuine expenses
associated with the pregnancy. Documentary evidence of the financial
arrangement for surrogacy must be available. The ART centre should
not be involved in this monetary aspect.
3.10.4 Advertisements regarding surrogacy should not be made by the ART
clinic. The responsibility of finding a surrogate mother, through
advertisement or otherwise, should rest with the couple, or a semen
bank (see 3.9.1.1; 3.9.2).
3.10.5 A surrogate mother should not be over 45 years of age. Before accepting
a woman as a possible surrogate for a particular couple’s child, the ART
clinic must ensure (and put on record) that the woman satisfies all the
testable criteria to go through a successful full-term pregnancy.
3.10.6 A relative, a known person, as well as a person unknown to the couple
may act as a surrogate mother for the couple. In the case of a relative
acting as a surrogate, the relative should belong to the same generation
as the women desiring the surrogate.
3.10.7 A prospective surrogate mother must be tested for HIV and shown to
be seronegative for this virus just before embryo transfer. She must also
provide a written certificate that (a) she has not had a drug intravenously
administered into her through a shared syringe, (b) she has not undergone
blood transfusion; and (c) she and her husband (to the best of her/his
knowledge) has had no extramarital relationship in the last six months.
(This is to ensure that the person would not come up with symptoms of
HIV infection during the period of surrogacy.) The prospective surrogate
mother must also declare that she will not use drugs intravenously, and
not undergo blood transfusion excepting of blood obtained through a
certified blood bank.
3.10.8 No woman may act as a surrogate more then thrice in her lifetime.
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3.11 Preservation, Utilization & Destruction of
Embryos
3.11.1 Couples must give specific consent to storage and use of their embryos.
The Human Fertilization & Embryology Act, UK (1990), allows a 5-
year storage period which India would also follow.
3.11.2 Consent shall need to be taken from the couple for the use of their stored
embryos by other couples or for research, in the event of their embryos
not being used by themselves. This consent will not be required if the
couple defaults in payment of maintenance charges after two reminders
sent by registered post.
3.11.3 Research on embryos shall be restricted to the first fourteen days only
and will be conducted only with the permission of the owner of the
embryos.
3.11.4 No commercial transaction will be allowed for the use of embryos for
research.
3.12 Rights of a Child Born through various ART

Technologies
3.12.1 A child born through ART shall be presumed to be the legitimate child of
the couple, having been born in wedlock and with the consent of both
the spouses. Therefore, the child shall have a legal right to parental
support, inheritance, and all other privileges of a child born to a couple
through sexual intercourse.
3.12.2 Children born through the use of donor gametes, and their “adopted”
parents shall have a right to available medical or genetic information
about the genetic parents that may be relevant to the child’s health.
3.12.3 Children born through the use of donor gametes shall not have any right
whatsoever to know the identity (such as name, address, parentage,
etc.) of their genetic parent(s). A child thus born will, however, be
provided all other information (including that mentioned in Section 3.4.8)
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about the donor as and when desired by the child, when the child
becomes an adult. While the couple will not be obliged to provide the
above “other” information to the child on their own, no deliberate attempt
will be made by the couple or others concerned to hide this information
from the child as and when asked for by the child.
3.12.4 In the case of a divorce during the gestation period, if the offspring is of
a donor programme – be it sperm or ova – the law of the land as pertaining
to a normal conception would apply.
3.13 Responsibilities of the Drug Industry

3.13.1 Drug companies must not make exaggerated claims for infertility drugs
and market them only to qualified specialists. All available information
on the drug must be provided to the specialist.
3.13.2 Infertility drugs must be sold only on prescription by a qualified doctor/
ART specialist.
3.13.3 There has been a spurt of new media introduced for in vitro culture of
gametes and embryos. Companies dealing with culture media do not
give full details of the composition because they wish to retain this as a
trade secret. This poses problems for those dealing with human embryos.
The future life of the products created in the laboratory is dependant, to
a certain extent, on the culture media used. ART centers should not
encourage companies that do not give details of the full composition of
the culture media. This will also make it possible to take legal action
against a company supplying something different from what it is stated
to be.
3.14 General Considerations

3.14.1 Minimum age for ART:
For a woman between 20 and 30 years, two years of cohabitation/
marriage without the use of a contraceptive, excepting in cases where
the man is infertile or the woman cannot physiologically conceive. For a
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woman over 30 years, one year of cohabitation/marriage without use of
contraceptives. Normally, no ART procedure shall be used on a woman
below 20 years.
3.14.2 Advertisements of an infertility centre:

False claims via hoardings and paper advertisements are a cheap way of
attracting a clientele that is vulnerable and, therefore, easily swayed.
Such advertisements shall be banned. An honest display at appropriate
places or publicity of statistics, fee structure, quality of service and of
service provided, will be encouraged, provided the guidelines laid down
by the Medical Council of India in this regard, are not violated.
3.14.3 As already mentioned, sperm banks where a complete assessment of

the donor has been done, medical and other vital information stored,
quality of preservation ensured, confidentiality assured, and strict control
exercised by a regulatory body, must be set up. Donor sperm would be
made available only through such specialized banks/centers.
3.14.4 In the light of a recent technological breakthrough where a fertilized
ovum containing ooplasm (including mitochondria) from a donor ovum
has been successfully cultured, the embryo or the future child may now
have three genetic parents. In such cases, the ooplasm donor must sign
a waiver relinquishing all rights on the child, and must be screened for
and declared free of known mitochondrial genetic abnormalities.
3.14.5 No new ART clinic may start operating unless it has obtained a
temporary registration to do so. This registration would be confirmed
only if the clinic obtains accreditation (permanent registration) from the
Center or State’s appropriate accreditation authority within two years
of obtaining the temporary registration. The registration must be renewed
every seven years.
3.14.6 Existing ART clinics must obtain a temporary registration within six
months of the notification of the accreditation authority, and appropriate
accreditation (permanent registration) within two years of the notification.
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3.14.7 The Center/State Government would close down any unregistered clinic
not satisfying the above criteria.
3.14.8 If the ART clinic that has applied for a temporary registration to the
appropriate accreditation authority, does not receive the registration (or
a reply) within two months of the receipt of the application from the
concerned office of the authority, the ART clinic would be deemed to
have received the registration. The same would apply for the permanent
registration after the above-prescribed period.
3.14.9 As pointed out in section 1.6.12.2, the technique of ICSI has never
undergone critical testing in animal models, but was introduced into the
human situation directly. Defects in spermatogenesis and sperm
production can be often traced to genetic defects. Such individuals are
normally prevented from transmitting these defects to their offspring
because of their natural infertility. ICSI by–passes this barrier and may
help in transmitting such defects to the offspring, which sometimes may
be exaggerated in the offspring. In view of this, the ART clinic must
point out to the prospective parents that their child born through ICSI
may have a slightly higher risk over and above the normal risk, of suffering
from a genetic disorder.
3.14.10 Human cloning for delivering replicas must be banned.
3.14.11 Stem cell cloning and research on embryos (less than 15 days old) needs
to be encouraged.
3.14.12 All the equipments/machines should be calibrated regularly.
3.15 Responsibilities of the Accreditation Authority

A State Accreditation Authority will be set up by the State Governments
through its Department of Health and/or Family Welfare to oversee all policy
matters relating to Accreditation, Supervision and Regulation of ART Clinics in
the States in accordance with the National Guidelines. The State Government
may also set up appropriate authorities for implementation of the Guidelines for
the whole or a part of State having regard to the number of the ART Clinics. The
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appropriate authority would have right to visit individually or collectively, any ART
Clinic/Centre(s) accredited or not accredited, once a year with or without prior
information to the clinic/center, to determine if the ethical guidelines and operative
procedures mentioned here are being followed. If not, the appropriate authority
will point out the lapses to the clinic/center in writing. If these lapses continued for
a maximum period of six months (during which period the clinic shall not engage in
any activity related to the lapses), the appropriate authority would recommend to
the State Accreditation Authority that the clinic/center may be ordered to be closed.
The State Accreditation Authority will have the powers to order the closing of
such a clinic or a center. The appropriate authority may be delegated powers to
impose a fine or a penalty on the center/clinic. The above-mentioned appropriate
authority would consist of appropriately qualified scientists, technologists and
sociologists. The appropriate authority will also be authorized to visit and regulate
semen banks in the manner mentioned above. In addition to the above, the Ministry
of Health and Family Welfare, Govt. of India, will set up a National Advisory
Committee. The National Advisory Committee may be headed by the Secretary,
Health and Family Welfare as chairman and the Director General of ICMR as co-
chairman. The National Advisory Committee will advise the Central Government
on policy matters relating to regulation of ART Clinics. Composition of the
Committee is given in Chapter 9.
The State Accreditation Authority will have the rights and the responsibility
of fixing the upper limit of charges for gamete donation and surrogacy and of
revising these charges from time to time.
3.16 Legal Issues

3.16.1 Legitimacy of the child born through ART
A child born through ART shall be presumed to be the legitimate child of
the couple, born within wedlock, with consent of both the spouses, and with all
the attendant rights of parentage, support and inheritance. Sperm/oocyte donors
shall have no parental right or duties in relation to the child, and their anonymity
shall be protected except in regard to what is mentioned under item 3.12.3.
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3.16.2 Adultery in the case of ART
ART used for married woman with the consent of the husband does not
amount to adultery on part of the wife or the donor. AID without the husband’s
consent can, however, be a ground for divorce or judicial separation.
3.16.3 Consummation of marriage in case of AIH
Conception of the wife through AIH does not necessarily amount to
consummation of marriage and a decree of nullity may still be granted in favor of
the wife on the ground of impotency of the husband or his willful refusal to
consummate the marriage. However, such a decree could be excluded on the
grounds of approbation.
3.16.4 Rights of an unmarried woman to AID
There is no legal bar on an unmarried woman going for AID. A child
born to a single woman through AID would be deemed to be legitimate. However,
AID should normally be performed only on a married woman and that, too, with
the written consent of her husband, as a two-parent family would be always better
for the child than a single parent one, and the child’s interests must outweigh all
other interests.
3.16.5 Posthumous AIH through a sperm bank
Though the Indian Evidence Act, 1872, says that a child born within 280 days
after dissolution of marriage (by death or divorce) is a legitimate child since that is
considered to be the gestation period, it is pertinent to note that this Act was
enacted as far back as 1872 when one could not even visualize ART. The law
needs to take note of the scientific advancements since that time. Thus a child
born to a woman artificially inseminated with the stored sperms of her deceased
husband must be considered to be a legitimate child notwithstanding the existing
law of presumptions under our Evidence Act. The law needs to move alongwith
medical advancements and suitably amended so that it does not give rise to dilemma
or unwarranted harsh situations.
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3.17 Institutional Ethics Committees
Each ART clinic of Levels 1B, 2 and Level 3 must have its own ethics
committee constituted according to ICMR Guidelines, comprising reputed ART
practitioners, scientists who are knowledgeable in developmental biology or in
clinical embryology, a social scientist, a member of the judiciary and a person who
is well-versed in comparative theology. Should the local ART clinic have difficulty
in establishing such a body, the state accreditation authority should constitute such
a body, co-opting a representative of the ART clinic.
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Chapter 4
Sample Consent Forms
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4.1 Consent Form to be signed by the Couple
We have requested the Centre (named above) to provide us with
treatment services to help us bear a child.
We understand and accept (as applicable) that:
1. The drugs that are used to stimulate the ovaries to raise oocytes have
temporary side effects like nausea, headaches and abdominal bloating.
Only in a small proportion of cases, a condition called ovarian hyper-
stimulation occurs, where there is an exaggerated ovarian response. Such
cases can be identified ahead of time but only to a limited extent. Further,
at times the ovarian response is poor or absent, in spite of using a high
dose of drugs. Under these circumstances, the treatment cycle will be
cancelled.
2. There is no guarantee that:

a. The oocytes will be retrieved in all cases.
b. The oocytes will be fertilized.
c. Even if there were fertilization, the resulting embryos would
be of suitable quality to be transferred.
All these unforeseen situations will result in the cancellation of any
treatment.
3. There is no certainty that a pregnancy will result from these procedures
even in cases where good quality embryos are replaced.
4. Medical and scientific staff can give no assurance that any pregnancy
will result in the delivery of a normal living child.
5. Endorsement by the ART clinic
I/we have personally explained to ________________________ and

__________________ the details and implications of his/her/their
signing this consent/approval form, and made sure to the extent humanly possible
that he/she/they understand these details and implications.
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6. This consent would hold good for all the cycles performed at the clinic.
Name and Signature of the Husband
Name and Signature of the Wife Name, Address and Signature

of the Witness from the clinic
Name and Signature of the Doctor
Dated:
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4.2 Consent for Artificial Insemination with Husband’s
Semen
________________________________________and____________________________
_______________, being husband and wife and both of legal age, authorize
Dr._______________________ to inseminate the wife artificially with the semen
of the husband for achieving conception.
We understand that even though the insemination may be repeated as
often as recommended by the doctor, there is no guarantee or assurance that
pregnancy or a live birth will result.
We have also been told that the outcome of pregnancy may not be the
same as those of the general pregnant population, for example in respect of abortion,
multiple pregnancies, anomalies or complications of pregnancy or delivery.
The procedure(s) carried out does (do) not ensure a positive result, nor
do they guarantee a mentally and physically normal body. This consent holds
good for all the cycles performed at the clinic.
Endorsement by the ART clinic
I/we have personally explained to _____________ and ___________ the details

and implications of his/her/their signing this consent/approval form, and made sure
to the extent humanly possible that he/she/they understand these details and
implications.
Name, Address and Signature of the Witness from the clinic
Signed: ___________________ (Husband)

____________________ (Wife)
Dated:
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4.3 Consent for Artificial Insemination with Donor
Semen
We, ____________________________________________________
and ____________________________, being husband and wife and both of
legal age, authorize Dr._______________________ to inseminate the wife
artificially with semen of a donor (registration no.________________; obtained
from ___________________ semen bank) for achieving conception.
We understand that even though the insemination may be repeated as often

as recommended by the doctor, there is no guarantee or assurance that pregnancy
or a live birth will result.
We have also been told that the outcome of pregnancy may not be the
same as those of the general pregnant population, for example in respect of abortion,
multiple pregnancies, anomalies or complications of pregnancy or delivery.
We declare that we shall not attempt to find out the identity of the donor.
I, the husband, also declare that should my wife bear any child or
children as a result of such insemination (s), such child or children shall be
as my own and shall be my legal heir (s).
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I/we have personally explained to ____________and __________ the

details and implications of his/her/their signing this consent/approval form, and
made sure to the extent humanly possible that he/she/they understand these details
and implications.
Name, Address and Signature

Signed: ________________________
(Husband)
(Wife) ________________________
Dated:
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4.4 Consent for Freezing of Embryos
We _________________________________________________ and
_______________________________ consent to freezing of the embryos that
have resulted out of IVF/ICSI with our gametes. We understand that the embryos
would be normally kept frozen for five years. If we wish to extend this period, we
would let you (the ART clinic) know at least six months ahead of time. If you do
not hear from us before that time, you will be free to (a) use the embryos for a
third party; (b) use them for research purposes; or (c) dispose them off. We also
understand that some of the embryos may not survive the subsequent thaw and
that frozen embryo-replaced cycles have a lower pregnancy rate than when fresh
embryos are transferred.
*Husband
In the unforeseen event of my death, I would like

The embryos to perish
To be donated to my wife
To be donated to a third party
Used for research purposes
Signed: Dated:
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*Wife
In the unforeseen event of my death, I would like

The embryos to perish
To be donated to my husband
To be donated to a third party
Used for research purposes
Signed Dated :
I/we have personally explained to _______________ and

______________the details and implication of his/her/their signing this
consent/approval form, and made sure to the extent humanly possible that
he/she/they understand these details and implications.
Name and Signature of the Doctor Dated
* The appropriate option may be ticked
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4.5 Consent for the Procedure of PESA and TESA
Name of female partner

Name of male partner
We hereby request and give consent to the procedure of PESA and TESA
for ICSI, to be performed on the male partner.
We understand that
a) There is no guarantee that the sperm will be successfully removed
or that sperm will necessarily fertilise our oocytes.
b) Should the sperm retrieval fail, the following options will be
available for the retrieved oocytes.
i) Insemination of all or some oocytes using donor sperm
ii) Donation of oocytes to another infertile couple
iii) Disposal of oocytes according to the ethical guidelines
(Tick the appropriate option)
Each of the above points has been explained to us by ______________
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I/we have personally explained to _____________ and ____________

the details and implications of his/her/their signing this consent/approval form, and
and implications.
Signature of Male Partner Name, Address and

Signature of the Witness
Signature of Female Partner from the clinic
Dated
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4.6 Consent for Oocyte Retrieval/Embryo Transfer
Woman’s Name:
Woman’s Address:
Name of the Clinic:
I have asked the Clinic named above to provide me with treatment services
to help me bear a child. I consent to:
a) Being prepared for oocyte retrieval by the administration of

hormones and other drugs
b) The removal of oocytes from my ovaries under ultrasound guidance/
laparoscopy
c) The mixing of the following:
My oocytes the sperm of my husband
Anonymous donor oocyte anonymous donor sperm
(Tick the appropriate and strike off the others)
d) the placing in my ________________________ of
e) 1. ___________ (no) of the oocytes mixed with the sperm
f) 2. ___________ (no) of the resulting embryos
g) 3. ___________ (no) of our cryo-preserved embryos
h) 4. ___________ (no) of embryo (s) obtained anonymously
I had a full discussion with ________________________ about the above

procedures and I have been given oral and written information about them.
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I have been given a suitable opportunity to take part in counselling about
the implications of the proposed treatment.
The type of anaesthetic proposed (general/regional/sedation) has been

discussed in terms which I have understood.
I/we have personally explained to _____________ and _____________

and implications.
Signature of Female Partner

Dated
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4.6.1 Consent of Husband
As the husband, I consent to the course of the treatment outlined above. I

understand that I will become the legal father of any resulting child, and that the
child will have all the normal legal rights on me.
Name, Address & Signature : _____________________________

(Husband)

of the witness from the clinic: ____________________________
Name and Signature of the Doctor: ________________________
Dated
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4.7 Agreement for Surrogacy
I, ______________________________ (the woman), with the consent

of my husband (name), of _________________________________ (address)
have agreed to act as a host mother for the couple, ____________
______________________________________________________ (wife) and
____________________________ (husband), both of whom are unable (or do
not wish to) to have a child by any other means.
I had a full discussion with ____________________________of the clinic

on ______________________ in regard to the matter of my acting as a surrogate
mother for the child of the above couple.
I understand that the methods of treatment may include:
1. Stimulation of the genetic mother for follicular recruitment

2. The recovery of one or more oocytes from the genetic mother by
ultrasound-guided oocyte recovery or by laparoscopy.
3. The fertilisation of the oocytes from the genetic mother with the
sperm of her husband or an anonymous donor.
4. The fertilisation of a donor oocyte by the sperm of the husband.
5. The maintenance and storage by cryopreservation of the embryo
resulting from such fertilisation until, in the view of the medical and
scientific staff, it is ready for transfer.
6. Implantation of the embryo obtained through any of the above
possibilities into my uterus, after the necessary treatment if any.
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I have been assured that the genetic mother and the genetic father have
been screened for HIV and hepatitis B and C before oocyte recovery and found
to be seronegative for all these diseases. I have, however, been also informed
that there is a small risk of the mother or/and the father becoming seropositive for
HIV during the window period.
I consent to the above procedures and to the administration of such drugs

that may be necessary to assist in preparing my uterus for embryos transfer, and
for support in the luteal phase.
I understand and accept that there is no certainty that a pregnancy will
result from these procedures.
I understand and accept that the medical and scientific staff can give no
assurance that any pregnancy will result in the delivery of a normal and living child.
I am unrelated/related (relation) _________________________ to the

couple (the would be genetic parents).
I have worked out the financial terms and conditions of the surrogacy with
the couple in writing and an appropriately authenticated copy of the agreement
has been filed with the clinic, which the clinic will keep confidential.
I agree to hand over the child to _______________________________

and ___________________ , the couple (to ___________________________
in case of their separation during my pregnancy, or to the survivor in case of the
death of one of them during pregnancy) as soon as I am permitted to do so by the
Hospital/Clinic/Nursing home where the child is delivered.
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I undertake to inform the ART clinic, _______________, of the result of
the pregnancy.
I take no responsibility that the child delivered by me will be normal in all

respects. I understand that the biological parents of the child have a legal obligation
to accept their child that I deliver and that the child would have all the inheritance
rights of a child of the biological parents as per the prevailing law.
I will not be asked to go through sex determination tests for the child
during the pregnancy and that I have the full right to refuse such tests.
I understand that I would have the right to terminate the pregnancy at my

will; I will then refund all certified and documented expenses incurred on the
pregnancy by the biological parents or their representative. If, however, the
pregnancy has to be terminated on expert medical advice, these expenses will not
be refunded.
I have been tested for HIV, hepatitis B and C and shown to be seronegative
for these viruses just before embryo transfer.
I certify that (a) I have not had any drug intravenously administered into
me through a shared syringe; (b) I have not undergone blood transfusion; and (c)
I and my husband have had no extramarital relationship in the last six months.
I also declare that I will not use drugs intravenously, undergo blood
transfusion excepting of blood obtained through a certified blood bank, and avoid
sexual intercourse during the pregnancy.
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I undertake not to disclose the identity of the couple.
In the case of the death of both the husband and wife (the couple) during
my pregnancy, I will deliver the child to ________________________ or
_____________________ in this order; I will be provided, before the embryo
transfer into me, a written agreement of the above persons to accept the child in
the case of the above-mentioned eventuality.
I/we have personally explained to _____________ and ____________

and implications.
Signed:
(Surrogate Mother)

Dated
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4.8 Consent Form for the Donor of Eggs
I Ms. ________________________ consent to donate my eggs to couples

who are unable to have a child by other means.
I have had a full discussion with Dr. __________________________

(name and address of the clinician) on ___________________________.
I have been counselled by ________________________________

(name and address of independent counsellor) on ______________________.
I understand that there will be no direct or indirect contact between me

and the recipient, and my personal identity will not be disclosed to the recipient or
to the child born through the use of my gamete.
I understand that I shall have no rights whatsoever on the resulting offspring

and vice versa.
I understand that the method of treatment may include:
• Stimulating my ovaries for multifollicular development.
• The recovery of one or more of my eggs under ultrasound-guidance or by

laparoscopy under sedation or general anesthesia.
• The fertilization of my oocytes with recipient’s husband’s or donor sperm

and transferring the resulting embryo into the recipient.
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Endorsement by the ART clinic/oocyte bank
I/we have personally explained to _______________ and __________

and implications.
Signed: _______________________
Dated
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4.9 Consent Form for the Donor of Sperm
I Mr. ________________________ consent to donate my sperm to

couples who are unable to have a child by other means.
I have had a full discussion with Dr. __________________________

(name and address of the clinician) on ___________________________.
I have been counselled by _______________________________ (name

and address of independent counsellor) on ______________________.
I understand that there will be no direct or indirect contact between the

recipient, and me and my personal identity will not be disclosed to the recipient or
to the child born through the use of my gamete.
I understand that I shall have no rights whatsoever on the resulting offspring

and vice versa.
Endorsement by the ART clinic/semen bank
I/we have personally explained to ______________ and ___________

and implications.
Signed: _______________________

Name and Signature of the Doctor Dated
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Chapter 5
Training
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5 Training
ART necessitates that the laboratory staff must have basic knowledge of
mammalian embryology, reproductive endocrinology, genetics, biochemistry,
molecular biology, microbiology, and in vitro culture techniques. The laboratory
staff must also be knowledgeable in the subjects practiced by the clinician. The
clinical staff must be well-versed in reproductive endocrinology, pathology,
endoscopy, ultrasonography, gynaecology and/or andrology. The clinician must
be knowledgeable about the importance of the procedures used in the embryology
laboratory. It is only through an understanding of the basic principles of the several
disciplines involved that an integrated team can be put in place to make a successful
ART clinic.
ART does not form a part of the medical curriculum anywhere in India
although the number (10 – 15% of the adult population in the reproductive age
group) of infertile couples needing ART is quite large. There is, therefore, a need
to institute training programes in ART. Such training can best be imparted in a
teaching institution, which has all the branches of the basic life sciences as distinct
disciplines, so that the trainees are exposed to the diverse disciplines involved in
ART. Alternatively, universities or other institutions having the appropriate basic
science departments can offer training for the laboratory staff, and medical
institutions can offer training in the clinical aspects of ART. Nevertheless, there
must be a nodal point where the staff trained in the above two types of institutions
can come and work together to acquire capabilities of practicing ART. Speciality
ART clinics, either in the public or the private sector, can act as such nodal points
and play a major role in establishing such training programmes.
Scientific discoveries and advances, especially in modern biological
sciences, are occurring at a very rapid pace. There is concomitant development of
new reproductive technologies. Training in ART should, therefore, be a continuous
and an ongoing process. The only way in which already trained staff could keep
up with the new advances is to take part in workshops and conferences organized
by scientific societies. The Government of India must encourage such conferences
through organizations such as the ICMR, Department of Science and Technology,
Department of Biotechnology, CSIR, and the various science academies in India.
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Chapter 6
Future Research Prospects
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6 Future Research Prospects
Progress in any field can only occur through research. There have
hardly been any publications by Indian scientists in the area of ART in peer
reviewed, internationally reputed, scientific journals, except for a few that
appeared from the Institute for Research in Reproduction in the late 1980’s.
Consequently, much of ART practice that is used in India is based on papers
published outside India, and there is hardly any information either on the
basic profile of the infertile couples in India or even on the clinical experience
in respect of the ART technologies developed elsewhere but used in India as
per the Western protocols.
ART offers a unique situation to study the biology of reproduction
in human subjects without compromising ethical issues. For example, it is
perfectly legitimate and ethical to take tissue and body fluid samples from an
infertile couple to study the cause of infertility. This is an area that has not
been exploited in India. Another line of research that is extremely important
is to study early embryonic development – subject that has remained in darkness
for quite a long time. What kinds of genes are turned on and off at different
stages of pre-implantation embryos? This would aid in developing methods
for implanting only the appropriate embryos in individuals who are known
carriers of inheritable genetic disorders. Can embryos be used for developing
tissues or organs (kidneys, pancreas etc.) for replacement? Stem cells obtained
from developing embryos hold much promise in this field of biotechnology.
There is hardly any serious research going on in such areas in the country. It
must be borne in mind that one important area of future medical advances, is
gene therapy, and such therapy may require in vitro fertilization and
development.
What is urgently required is the identification of projects that are of
value to advance our knowledge of human reproduction and develop better
methods for treating infertility, or even identify better contraceptives because
infertility is the kind of situation that we intend to create in a fertile couple
desirous of limiting their family size. Following such identification, research
in reproduction, with special reference to infertility treatment, must be
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identified as a priority area for research for funding by the national scientific
agencies.
6.1 Pre-implantation Genetic Diagnosis and
Chromosomal and Single-Gene Defects
There is a growing volume of information that is now available
showing that many forms of infertility are caused by genetically transmittable
disorders. The genetic disorders include trisomy, translocations, inversions,
deletions and microdeletions. All this new information suggests that great
care must be exercised with ART because infertile couple may be carriers of
such disorders; when one tries to force fertilization, the question arises whether
one is transmitting genetic disorders to the offspring. This raises many moral
and ethical issues.
One way to get around this problem is to institute top-class genetic
diagnostic facilities that will be able to carry out diagnosis of genetic defects
in single cells obtained from embryos. This is a very expensive and labor-
intensive project and therefore there is a need to establish just a few well-
equipped centers in the country and later expand them if there is a need.
These centers could serve as referral centers and should be used judiciously.
The establishment of such centers will go a long way in placing ART practice
in India on a firm, healthy and ethical footing.
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Chapter 7
Providing ART services to the

Economically Weaker Sections of the
Society
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7.0 Providing ART services to the Economically
Weaker Sections of the Society
7.1 The setting up of a modern ART clinic and running it satisfactorily is

an expensive affair, requiring a dedicated staff that would render long-
term service. The setting up of ART clinics in the public sector, which
do not exist as of now, must be explored.
7.2 Reduction of drug costs: The concerned Ministries must take a look
at the reason for the high cost of ovarian stimulation hormones, and
encourage and support local pharmaceutical industries to start
manufacture of human menopausal gonadotropins indigenously so that
the treatment of our infertility patients is not dictated by the commercial
motives of the multinational pharmaceutical companies but by national
needs.
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Chapter 8
Establishing a National Database for

Human Infertility
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8 Establishing a National Database for Human
Infertility
It is important to realize that diagnostic and therapeutic approaches
in reproductive medicine have to keep pace with rapidly developing molecular
knowledge of human reproduction. It is now possible to detect the incidence
of chromosomal abnormalities using a variety of high-powered PCR techniques
(Human Reproduction 13: 3032-3038, 1998.) and multicolour fluorescent in
situ hybridization (FISH) analysis (Chromosome 6:481-486,1998; Human
Reproduction 16:115-120,2001). FISH studies on sperm are becoming
necessary to understand whether there is a genetic cause for male infertility,
before patients can be subjected to ICSI. New spermatogenesis genes are
bound to be discovered (Endocrinological Investigations 23: 584-591, 2000);
testing their mutation will become easier with DNA chips and microarray
technology.
Unfortunately, there is no documented database available in our
country that would cover data on all aspects of infertility, and there is an
urgent need for the same. It is worrisome to see that, with the primary aim of
providing a child to the infertile couple, a variety of sophisticated ART are
being used to overcome male factor infertility without understanding the
underlying cellular and molecular etiology. In the process of curing infertility
in the patient, there is a high iatrogenic risk of transmitting an abnormal
paternal geno-(pheno-)type to the ART-born child. An appropriate database
would allow the quantification of such risks.
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Chapter 9
Composition of the National

Advisory Committee
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9 Composition of the National Advisory Committee
Chairman: Secretary, Ministry of Health and Family Welfare, Govt. of India.
Co-chairman: Director General, Indian Council of Medical Research, New Delhi.

Executive Secretary: A officer below the rank of Joint Secretary in Ministry of
Health and Family Welfare, Govt. of India.
Members:
♦ Representative of the Indian Council of Medical Research.
♦ Representative of the National Academy of Medical Sciences.
♦ Representative from the Ministry of Health & Family Welfare, Govt. of
India.
♦ Representative of a scientific society that deals with ART. Care must be
taken to ensure that such a representative should be from a society that
has democratically elected office bearers and is governed by reasonable
rules and regulations. The representative must have a proven track record
of having contributed significantly to ART. The nature of the person’s
association with commercial companies must be made known publicly.
♦ A social scientist of repute.
♦ The Chairman of the National Bioethics Committee.
♦ A gynaecological endocrinologist.
♦ A gynaecological sonographist.
♦ An operative gynaecologist.
♦ A mammalian reproductive biologist.
♦ An andrologist.
♦ A representative of NGOs.
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♦ A counsellor.
♦ A representative of patients.
♦ A medico-legal expert.
♦ A representative of FOGSI.
♦ A representative of ISSRF.
Notes: 1. A meeting of the National Advisory Committee may be chaired either

by the Chairman or Co-chairman.
2. The Advisory Committee should meet at least once in six months.
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Bibliography
1. Anand Kumar T C, Hinduja I, Joshi S, Kelkar M D, Gaitonde S, Puri C P,
Iyer J and Ranga G. In-Vitro fertilization and embryo transfer in India.
ICMR Bulletin, 16, (4), 1986.
2. Asch R, Balmaceda, J, Ord T, Borrero C, Cefalu E, Gastaldi C and Rojas

F. Oocyte donation and gamete intrafallopian trasfer as treatment for
premature ovarian failure. Lancet, Mar 21,1(8543), 687, 1987.
3. Biggers J D. Ethical issues and the commercialization of embryo culture

media. Reproductive Biomedicine,1, (3), 74-76, 2000.
4. Bonduelle M, Aytoz A, VanAssche E, Devroey P, Liebaers I and Van

Steirteghem A. Incidence of chromosomal aberrations in childern born
after assisted reproduction through intracytoplasmic sperm injection.
Human Reproduction, 13, 781–782, 1998.
5. Brinsden P R (Ed.). A Textbook of In Vitro Fertilization and Assisted

Reproduction. The Parthenon Publishing Group, New York and London,
1999.
6. Brown, Lesley and John, with Freeman, Sue. Our Miracle Called Louise
– A Parents’ Story. Paddington Press Ltd, USA & UK.
7. Chakravarty B N. Legislation and Regulations Regarding the Practice of

Assisted Reproduction in India. J. Assisted Reprod. Genetics, 18, 10-14,
2001.
8. Code of Medical Ethics, framed under Section 33 of the Indian Medical

Council Act, 1956.
9. Cram D S, Ma K, Bhasin K, Arias J, Pandjaitan M, Chu B, Audrins P,

Saunders D, Quinn F, Dekretser D and McLachlan R. Y-chromosome
analysis of infertile men and their sons conceived through intracytoplasmic
119
283
sperm injection: Vertical transmission of deletions and rarity of de novo
deletions. Fertil. Steril., 74, 909–915, 2000.
10. de Wert G. M. Ethics of intracytoplasmic sperm injection: proceed with

care. Human Reproduction, Suppl 1: 219-227, 1998.
11. Edwards R G. Maturation in vitro of human ovarian oocytes. Lancet,

Nov 6, 2(7419) 926-929, 1965.
12. Ethical Guidelines on Assisted Reproductive Technology. NHMRC

document, Commonwealth of Australia, ISBN O 644 47272 3, 1996.
13. Ethical Guidelines for Biomedical Research on Human Subjects. Indian

Council of Medical Research, New Delhi, 2000.
14. Gianaroli L, Plachot L, van Kooij R, Al-Hasani S, Dawson K, DeVos A,

Magli M C, Mandelbaum J, Selva J and van Inzen W. ESHRE guidelines
for good practice in IVF laboratories. Committee of the Special Interest
Group on Embryology of the European Society of Human Reproduction
and Embryology. Human Reproduction, 15, 2241 - 2246, 2000.
15. Gianaroli L, Plachot L, Magli M C. (eds). Atlas of Embryology. Human

Reproduction, 15, (Suppl. 4), 2000.
16. Human Fertilization and Embryology Act. London: Her Majesty’s

Stationery Office, 1990.
17. Human Fertilization and Embryology Authority. Code of Practice, HFEA,

London, 1993.
18. ISLAT Working Group. ART in to Science: Regulation of Fertility

Techniques. Science, 281, 651–652, 1998.
19. Ked B A, Jeffrey V M and De Jonge C J. Handbook of the Assisted

Reproduction Laboratories. Brooks (Ed.), CRC Press, Washington DC
2000.
120
284
20. Kostiner D R, Turek P J and Reijo R A. Male infertility: analysis of the
markers and genes on the human Y-chromosome. Human Reproduction,
13, 3032–3038, 1998.
21. Lalonde A B. Draft Legislation for Assisted Human Reproductive

Technologies. The Standing Committee on Health, Parliament of Canada.
The Society of Obstetricians and Gynecologists of Canada, 2001.
[email protected]
22. Lansac J. French law concerning medically assisted reproduction. Human

Reproduction, 11, 1843-1847, 1996.
23. Macas A, Imthurn B and Keller P J. Increased incidence of numerical

chromosome abnormalities in spermatozoa injected into human oocytes
by ICSI. Human Reproduction, 16, 115–20, 2001.
24. Mukerji S, Mukerji S and Bhattacharya S K. The feasibility of long-term

cryogenic freezing of viable human embryos – a brief pilot study report.
Ind. J Cryog., 3, 80, 1978.
25. Piotrowska K and Goetz M Z. Role for sperm in spatial patterning of the
early mouse embryo. Nature, 409, 517–521, 2001.
26. The Ethics Committee of the American Fertility Society. Ethical

Considerations of the New Reproductive Technologies. Fertil. Steril., 62
(Suppl. 5), 1215-1255, 1994.
27. The Medical Council of India Act, 1956.
28. The Nuremberg Code. Trials of war criminals before the Nuremberg
Military Tribunals under control. Council law no. 10, US Government
Printing Office, Washington DC 2, 181-182, 1949.
29. The Pre-natal Diagnostic Techniques (Regulation and Prevention of

Misuse) Act, Government of India, 1994.
121
285
30. The Transplantation of Human Organs Act, Government of India, 1994.
31. World Health Organization (WHO) Laboratory Manual for the

Examination of Human Semen and Sperm-Cervical Mucus Interaction.
Cambridge University Press, Cambridge, 1999.
32. World Medical Association. Declaration of Helisinki, 41st World Medical

Assembly, Hong Kong, 1989.
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Members of Expert Group for Formulating the
National Guidelines for Accreditation, Supervision
and Regulation of ART Clinics in India
Chairman
1. Dr. Baidya N. Chakravorty

Institute of Reproductive Medicine,
DD-18/5/1, Sector 1
Salt Lake City, Kolkatta - 700 064
Members
2. Dr. Pushpa M. Bhargava

Padma Bhushan
Former and Founder Director, CCMB,
Anveshna, Furqan Cottage
12-13-100 Lane # 1, Street # 3, Tarnaka
Hyderabad – 500 017
3. Dr. Anand Kumar T C

Former Director, IRR, Mumbai
Chairman
Hope Infertility Clinic
Ashwini
33/1, Aga Abbas Ali Road
Bangalore – 560 042
4. Dr. Sulochana Gunasheela

Obstetrician and Gynaecologist
Gunasheela Surgical and Maternity Hospital
1, Dewan N. Madhava Rao Road,
Basavangudi, Bangalore – 560 004
123
287
5. Dr. Sudarsan Ghosh Dastidar
Director
Ghosh Dastidar Institute for Fertility Research (P) Ltd.
208, Rashbehari Avenue,
Kolkatta – 700 029
6. Dr. Mohinder Kochhar

Sr. Consultant Obst. and Gynaecologist
Specialist in Infertility/IVF,
Sir Ganga Ram Hospital
Rajinder Nagar, New Delhi – 110060
7. Dr. Kamini Rao

Bangalore Assisted Conception Centre
6/7 Kumara Krupa Road,
Highground
Bangalore-560001
8. Dr. Mehroo D. Hansotia

Fertility Clinic & IVF Centre
12, Spring Field, 1st Floor
19, Vachha Gandhi Road
Gamdevi, Mumbai – 400 007
9. Dr. Sadhana K. Desai

Fertility Clinic & IVF Centre
12, Spring Field, 1st Floor
19, Vachha Gandhi Road
Gamdevi, Mumbai – 400 007
124
288
10. Dr. Chander P. Puri
Director
National Institute for Research in Reproductive Health
Jehangir Merwanji Street,
Parel, Mumbai-400012
11. Dr. Firuza R. Parikh

Director
Dept. of Assisted Reproduction & Genetics
Jaslok Hospital & Research Centre,
15, Dr. G. Deshmukh Marg
Mumbai – 400 026
12. Shri Rajeev Dhavan

Senior Advocate
Supreme Court of India,
A – 131, New Friends Colony
New Delhi – 110 065
13. Dr. Mira Shiva

Head of Public Policy
Voluntary Health Association of India (VHAI)
40, Institutional Area South of IIT
14. Dr. Lalrintluangi

Deputy Commissioner
Deptt. of Family Welfare,
Govt. of India, Nirman Bhawan
125
289
15. Dr. Vikram K. Behal
Deputy Commissioner
Deptt. of Family Welfare,
Govt. of India, Nirman Bhawan
16. Dr. Vasantha Muthuswamy

Sr. Deputy Director General
Division of Basic Medical Sciences
17. Shri. Nirakar C. Saxena

Deputy Director General (SG) and Chief
Division of Reproductive Health and Nutrition
18. Dr. Radhey S. Sharma

Deputy Director General
19. Dr. Nomita Chandhiok

Assistant Director General
//true copy//
126
290
SECTION – X

Civil / Criminal/Appellate/Original/Jurisdiction
WP (C) NO. ……………. OF 2022
IN THE MATTER OF:
DR.ANIRUDDHA NARAYAN
MALPANI & ORS.
____________________________________________ PETITIONER(S)
VERSUS
UNION OF INDIA & ORS.
____________________________________________ RESPONDENT(S)
INDEX
_________________________________________________________________________
S.No. Particulars Copies Court Fees
1. Listing Proforma
2. List of Dates
3. WP with affidavit
4. Annexures
5. Vakalatnama
(MOHINI PRIYA)
Advocate for the Petitioners
Ch. 01, C.K.Daphtary Block,
Supreme Court of India, New Delhi
Email: [email protected]
Code- 2977
Mob: 99713 02878
Dated: 03.12.2022

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IN THE SUPREME COURT OF INDIA

CIVIL ORIGINAL JURISDICTION

WRIT PETITION NO._________ OF 2022

[A Writ Petition under Article 32 of the Constitution of India for

Enforcement of Fundamental Rights Guaranteed Under Part-III

IN THE MATTER OF:

MALPANI & ORS. …. PETITIONERS

UNION OF INDIA & ORS. …. RESPONDENTS

[KINDLY SEE INDEX INSIDE]

ADVOCATE FOR THE PETITIONERS: MS. MOHINI PRIYA

Sl. Particulars of Document Page No. of part to Remarks

(iii) (iv) (v)

(b) Email I.D. : N.A.

(b) FIR No. : N.A

The present writ petition has been filed by a group of doctors

invoking the extraordinary jurisdiction of this Hon’ble Court

under Article 32 of the Constitution praying to this Hon’ble

Court to strike down the unconstitutional, arbitrary,

unreasonable and unscientific provisions introduced by the

Assisted Reproductive Technique (Regulation) Act, 2021

(hereinafter referred to as the “ART Act”) alongwith the

Assisted Reproductive Techniques(Clinic) Rules, 2022

(hereinafter referred to as the ART Rules), which together have

brought about a repressive and discriminatory regime which in

denial of reproductive autonomy of women. The specific

provisions under are Section 21(b) r/w Rule 3, Section 21(g),

Section 22(1)(b), Section 27(1), Section 27(4), Section 29 and

Section 33 of the ART Act.

That the Petitioners herein seek indulgence of this Hon’ble

Court under Article 32 of the Constitution for the rights of egg

donors and childless couples which as part of doctor-patient

relationship they are duty bound to protect as well as rights of

medical practitioners, primarily on the following grounds:

being in derogation of International Best Practices and

ICMR Guidelines of 2010 for IVF clinics;

(ii) The Act imposes unreasonable restrictions on egg donors

which are unscientific and in violation of reproductive

(iii) Lack of any provision for monetary consideration for

oocyte donors is violative of their right to life;

(iv) Complete ban on embryo transfer and lack of transitory

provisions for embryos frozen prior to the enforcement

of the Act is creating difficulties for childless couples

desirous of availing ART services;

(v) Arbitrary age restrictions for couples desirous of availing

ART processes through donor eggs is violative of

reproductive rights of women;

(vi) Mandatory collection of donor gametes by an ART Bank

instead of an ART Clinic makes the process cumbersome

(vii) Exclusion of live-in couples, same sex couples and single

men from availing ART Services;

(viii) Bringing medical practitioners under the rigours of the

Indian Penal Code, 1860 by providing stringent penalties

and imprisonment for contravention of the Act is

unreasonable and violative of Article 19 and 21 of the

The statement of objects and reasons of the ART Act states

“An Act for the regulation and supervision of the

assisted reproductive technology clinics and the assisted

reproductive technology banks, prevention of misuse,

safe and ethical practice of assisted reproductive