Learn everything you need to know about Screening Gamete Donors.

1. Dr. Laxmi Shrikhande MD; FICOG; FICMU;FICMCH
• Medical Director-Shrikhande Fertility Clinic, Nagpur
• Chairperson Designate ICOG 2020 , Vice Chairperson ICOG 2019
• National Corresponding Editor-The Journal of Obstetrics & Gynecology of India
• Senior Vice President FOGSI 2012
• Patron & President -Vidarbha Chapter ISOPARB
• Received Nagpur Ratan Award at the hands of Union Minister Shri Nitinji Gadkari
• Received Bharat excellence Award for women’s health
• Received Mehroo Dara Hansotia award for Best Committee of FOGSI
• National Governing Council member ICOG 2012-2017
• National Governing Council Member ISAR 2014-2019
• National Governing Council Member IAGE for 3 terms
• Chairperson-HIV/AIDS Committee, FOGSI (2007-09)
• President Nagpur OB/GY Society 2005-06
• Immediate Past President Menopause Society, Nagpur
• Associate member of RCOG
• Member of European Society of Human Reproduction
• Visited 96 FOGSI Societies as invited faculty
• Delivered 11 orations and 450 guest lectures
• Publications-Twenty National & eleven International
• Presented Papers in FIGO, AICOG, SAFOG, AICC-RCOG conferences
• Conducted adolescent health programme for more than 15,000 adolescent girls
• Conducted health awareness programme for more than 10,000 women

2. Screening Gamete
Donors
DR LAXMI SHRIKHANDE
NAGPUR

3. Overview
Are there any laws / guidelines ?-Legal issues
How to proceed for gamete screening –medical issues
How to ensure safety of egg donors-Ethical issues
Is there any full proof method to assure gamete recipients
Take Home Message

4. History
Use of donor sperm can be traced back to the 1800s
Oocyte donation was introduced in mid 1980

5. Who needs Donor Gamets ?
Obviously who don’t have their own gametes
Sperm donation-part of IUI cycle
Egg donation- part of IVF cycle-issues of donor safety as well

6. Do we have Indian laws for the same ?

7. ART Bank
At present no legislation in regard to the practice of ART in India.
Proposed bill is pending in Lok Sabha
ICMR provides Reg no to ART clinics but not to ART banks
As of today we all are following ICMR Guidelines

8. Age limit for Gamete donor by ICMR
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 egg donor woman between 21 and 35 years.

9. Consent for gamete donors
Written informed consent of the donor and spouse is must

10. Oocyte Donor
 Selection
 Screening

11. 3.7 Requirements for an Oocyte Donor
3.7.3 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.

12. 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.

13. Selection of egg donor
couples do not focus as much on caste and colour as
before, in the desperation to have a child.
But concerns are expressed about education,
professional status, religion and medical history of
the donor.

14. Selection of Egg Donors
Psychological evaluation and counselling by a qualified
mental health professional is strongly recommended for the
oocyte donor and her partner (if applicable).
The psychological assessment also should address the
potential psychological risks and evaluate for evidence of
coercion (financial or emotional).

15. Selection of Egg Donors
No owner, operator, laboratory director, or employee of a
facility screening for or performing oocyte donation may
serve as a donor in that practice.
If an agency is used to recruit oocyte donors, no individual
who has a financial interest in that agency may be used as
an oocyte donor.

16. B. Screening and testing of oocyte donors
Detail History-A complete personal and sexual history should be
obtained to exclude as donor individuals who might be at high risk
for HIV, STIs, or other infections that might be transmissible via
gamete donation.
Physical examination-Before acceptance, and every 6 months while
remaining an active donor, donors should undergo a complete
physical examination
Gynecological Examination
TVS to rule out pelvic pathology

17. B. Screening and testing of oocyte donors
Laboratory testing
There is no method to ensure completely that infectious agents will
not be transmitted via oocyte donation.
However, an adequate medical history and specific exclusion of
individuals at high risk for HIV and other STIs, should dramatically
reduce these risks.

18. FORM - M1 Information on Oocyte Donor
BASIC INFORMATION:
1. Identification number (Donor ID)
2. Age / Date of birth
3. Marital status
4. Education: a. Donor b. Spouse
5. Occupation : c. Donor d. Spouse
6. Monthly income
7. Religion

19. HISTORY:
8. Obstetric history- a. Number of deliveries b. Number of abortions c. Other
points of note
9. Menstrual history
10. History of use of contraceptives
11. Medical history
12. Family history from the medical point of view
13. History of any abnormality in a child of the donor
14. History of blood transfusion
15. History of substance abuse
FORM - M1 Information on Oocyte Donor

20. INVESTIGATIONS(1):
16. Blood group and Rh status
17. Complete blood picture: a. Hb b. Total RBC count c. Total WBC count d.
Differential WBC count
e. Platelet count f. Peripheral smear
18. Random blood sugar
19. Blood urea / Serum creatinine
20. SGPT
21. Routine urine examination
FORM - M1Information on Oocyte Donor

21. INVESTIGATIONS(1):
22. HBsAg status
23. Hepatitis C status
24. HIV status with date of the tests done
25. Hemoglobin A2 (for thalassemia) status
26. Any other specific test (2)
FORM - M1Information on Oocyte Donor

22. FEATURES:
27. Height
28. Weight
29. Colour of skin
30. Colour of hair
31. Colour of eyes
FORM - M1 Information on Oocyte Donor

23. DETAILED PHYSICAL EXAMINATION:
32. Pulse
33. Blood pressure
34. Temperature
35. Respiratory system
36. Cardiovascular system
37. Per abdominal examination
Other systems
FORM - M1 Information on Oocyte Donor

24. Footnotes:
(1) To be carried out within 15 days prior to oocyte donation
(2) Any additional test carried out on the basis of the history and examination of
Donor
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
To the patient, a copy of this form without items 16-26 filled in, may be given when asked for.
The investigations in items 16-26 may be done when the patient has
chosen the donor provisionally, subject to the results of tests in items 16-26 being satisfactory.
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Name(s) and signature(s) with date, of persons filling the form:
FORM - M1Information on Oocyte Donor
(See Rule 15.1)

25. Egg donation is always a part of IVF
Donor safety is paramount from the risk of OHSS and inherent
surgical and anaesthesia risks during OPU procedure
No over stimulation of donors
Detail Counselling of the donor and her husband
Written consent of the donor and her husband
Should donate voluntarily without any coercion or undue influence
No woman shall donate oocytes more than 6 times in her life, with
not less than a 3 month interval between the oocyte pick ups

26. 3.9.3. Oocyte sharing
Eggs from one donor can be shared between 2 recipients
only, provided that t least 7 oocytes are available for each
recipient
No woman should be treated with gametes or embryos
derived from the gametes of more than 1 man or woman
during any one treatment cycle
If sharing of oocytes is contemplated, informed consent
must be obtained before the start of the cycle of retrieval.

27. Sharing of semen sample
One sample of semen supplied by an ART bank shall be
used by the ART clinic only once on only one recipient
An ART clinic shall never mix semen from 2 individuals
before use

28. Can ART clinics buy gametes ?
Sale of gametes / zygotes / embryos outside India-prohibited
Sale of zygotes / embryos in India-prohibited
Gametes can be sold for ART to ART clinic by ART bank for
treatment of infertility in India
The ART draft Bill 2010

29. Sourcing of gametes through ART Bank
ART Bank means an organisation that is set up to supply sperm /
semen, oocytes / oocyte donors and surrogate mothers to assisted
reproductive technology clinics or their patients.
Bill makes it mandatory for the ART clinics to procure the gamete as
well as gamete donors through the ART Bank.

30. Screening Sperm Donor

31. 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,

32. 3.6 Requirements for a Sperm Donor
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.

33. 1.6.8.1 Freezing semen
Any donor semen has to be quarantined for six months.
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.

34. FORM - M
Information on Semen Donor ( See Rule 15.1 )
Date of filling the form:
BASIC INFORMATION:
1. Identification number (Donor ID)
2. Age / Date of birth
3. Marital status
4. Education : a. Donor b. Spouse
5. Occupation : a. Donor b. Spouse
6. Monthly income
7. Religion

35. FORM - M
Information on Semen Donor ( See Rule 15.1 )
HISTORY:
8. Obstetric history of wife :
a. Number of deliveries b. Number of abortions c. Other points of note
9. History of use of contraceptives
10. Medical history
11. Family history from the medical point of view
12. History of any abnormality in a child of the donor
13. History of blood transfusion
14. History of substance abuse

36. FORM - M
Information on Semen Donor ( See Rule 15.1 )
INVESTIGATIONS:
15. Blood group and Rh status
16. Complete blood picture:
17. Random blood sugar
18. Blood urea / Serum creatinine
19. SGPT 20. Routine urine examination
21. HBsAg status 22. Hepatitis C status
23. HIV status with date of the tests done
24. Hemoglobin A2 (for thallasemia) status
25. HIV PCR (2) (positive or negative)
26. Any other specific test (3)

37. FEATURES:
27. Height
28. Weight
29. Colour of skin
30. Colour of hair
31. Colour of eyes
FORM - M
Information on Semen Donor ( See Rule 15.1 )

38. DETAILED PHYSICAL EXAMINATION:
32. Pulse
33. Blood pressure
34. Temperature
35. Respiratory system
36. Cardiovascular system
37. Per abdominal examination
38. Other systems
FORM - M
Information on Semen Donor ( See Rule 15.1 )

39. Footnotes:
(1) To be carried out every 6 months
(2) To be carried out if donor leaves within 6 months of the previous HIV test
(3) Any additional test carried out on the basis of the history and examination of donor
–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
All the tests should have been done within 15 days prior to the date of filling the
form.
–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Name and signature with date, of the person filling the form:
FORM - M
Information on Semen Donor ( See Rule 15.1 )

40. Ethical Issues-Genetic screening
Genetic screening –to do or not to do ?

41. Genetic screening should be done
Donor conception should be as safe as reproduction
between healthy partners
All donors should be karyotyped: although the risk of a
healthy donor carrying a balanced translocation is small (2
per 1000), the implications (an abortion or a handicapped
child) are severe, and the test to avoid this is not too
expensive and without adverse consequences for the donor
Human Reproduction, Vol.29, No.7 pp. 1353–1359, 2014

42. Genetic screening should not be done
Even if in a future scenario it becomes possible to
affordably and reliably select donors on the basis of a
completely analyzed genome scan, this will still not mean
that donor conception can be absolutely safe.
Moreover, serious disorders caused by de novo mutations
will still emerge; however, widely donors are tested.
it is important to stress that in human reproduction,
genetic risks can never be completely ruled out
Human Reproduction, Vol.29, No.7 pp. 1353–1359, 2014

43. ESHRE Task Force on Ethics and Law:
genetic screening of gamete donors:
ethical issues
This Task Force document explores the ethical issues
involved in the debate about the scope of genetic screening
of gamete donors.
Ethical principles require that all stakeholders’ interests are
taken into account, including those of candidate donors.
The message of the profession should be that avoiding all
risks is impossible and that testing should remain
proportional.
Human Reproduction, Vol.29, No.7 pp. 1353–1359, 2014

44. Commercial interests and medico legal
implications
It is unfortunate that the debate about the scope of genetic
screening of gamete donors is partly driven by commercial
interests rather than by a proper assessment of clinical
utility.
With the advent of powerful new testing technologies,
centers may be even more inclined to use claims to greater
genetic safety as a competitive edge

45. Attitudes of sperm, egg and embryo
donors and recipients towards genetic
information and screening of donors
 Donors and recipients acknowledged the importance of genetic information
and were comfortable with the existing level of genetic screening of donors.
Recipients recognised some potential benefits of expanded genetic screening of
donors; however both recipients and donors were apprehensive about extended
genomic technologies,with concerns about how this information would be used
and the ethics of genetic selectivity.
Conclusion: Participants in donor programs support some level of genetic
screening of donors, but are wary of expanding genetic screening beyond
current levels.
Amor et al. Reproductive Health (2018) 15:26

46. Recommendations-ESHRE Task force
† There is a need for expert guidance with regard to the clinical validity and
utility of expanded donor screening protocols.
† † At the moment, NGS (or array) based risk profiling is fully disproportional.
† † No tests of donors and recipients should be carried out without proper
informed consent and adequate implications counseling.
† Commercial interests should not be allowed to drive the debate about the
scope of genetic screening of donors.
† Instead of giving in to the illusion of ‘preventative perfectionism’, the
message of the profession should be that avoiding all risks is impossible and
that testing should remain proportional.

47. Rights & Duties of patient
The parents of a minor child have the right to access
information about the donor, other than the name, identity
or address of the donor, when and to the extent necessary
for the welfare of the child

48. Rights & Duties of Donors
All information about the donors shall be kept confidential and information about gamete
donation shall not be disclosed to anyone other than the central database of the department of
health research , except with the consent of the person or persons to whom the information
relates, or by an order of a court of competent jurisdiction.
The donors shall have the right to decide what information may be passed on and to whom,
except in the case of an order of a court of competent jurisdiction.
A donor shall relinquish all parental rights over the child which may be conceived from his or her
gamete
No assisted reproductive technology procedure shall be conducted on or in
relation to any gamete of a donor under this act unless such donor has obtained
the consent in writing of his or her spouse, if there, to such procedure.
The identity of the recipient shall not be made known to the donor

49. Sperm donation-ICMR guidelines
The collection, screening and storage of semen; and provision of
oocyte donor shall be done by an ART bank registered as an
independent entity under the provisions of this act.
An ART bank shall operate independently of any assisted
reproductive technology clinic
An ART bank shall not supply the sperm of a single donor for use
more than 75 times.
One sample of semen supplied by an ART bank shall be used by the
ART clinic only once on only one recipient
No ART clinic shall never mix semen from 2 individuals before use

50. Ethical & legal issues about anonymity of
gamete donors
No ART clinic shall obtain or use sperm or oocyte donated
by relative or known friend of either of the parties seeking
ART treatment or procedures

51. FORM - R
Contract between the ART bank and the
Semen Donor
(See Rule 15.1)

52. FORM - R1
Contract between the ART bank and the
Oocyte Donor
(See Rule 15.1)

53. FORM - S
Contract between the ART bank and the
Patient
(See Rule 15.1)

54. FORM - T
Contract between the ART bank and the ART
Clinic
(See Rule 15.1)

55. Summary
The ethical guidelines should go beyond technicalities and build
effective safeguards so that the unequal power relationship between
the recipient and donors of new technology is minimised.
The guideline should also keep in mind the unequal gender balance
and ensure the safety of egg donors from medical, surgical risks and
also from the coercion
At the same time guidelines should also ensure the hassle free
functioning of ART clinics
In the absence of law Moral policing is the need of hour

56. Take Home message
ICMR guidelines allows ART clinics to buy gametes from the ART banks for the
purpose of ART treatment
ICMR has elaborate proforma for both oocyte and sperm donor on its website
which every ART clinic is supposed to fill and adhere to.
ICMR also has different contract forms which needs to be filled and adhered to
Gamete donors should be above 21 years of age
Anonymity has to be maintained
Selection and screening of donors is mandatory as per ICMR guidelines
Gamete sharing is allowed with proper informed written consent provided each
recipient is getting 7 oocytes
Records should be kept for minimum 18 years

57. Questions

58. Dr. Laxmi Shrikhande
Shrikhande Fertility Clinic
Ph-8805577600 /8805677600
shrikhandedrlaxmi@gmail.com

59. The Art of Living
Anything that
helps you to
become
unconditionally
happy and loving
is what is called
spirituality.
H. H. Sri Sri Ravishakar