Obstetrics and gyneacology

1. Ethical Issues in Assisted
Reproduction
Presented By: Dr. A. P. Soibi-Harry
REF Unit

2. Outline
• Introduction
• Definitions
• Importance
• Issues
• Where We Are
• What Next
• Conclusion

3. Introduction
• Infertility has traditionally been an area of medicine in which physicians
had limited means to help their patients.
• The landscape of this field changed dramatically with the announcement
of the birth of Louise Brown in 1978 through in vitro fertilization (IVF).
• Assisted reproductive techniques have become more available such that it
now accounts for 1% of all live births in the USA.
• However, the explosion of this technology has introduced a myriad of new
social, ethical, and legal challenges.

4. Assisted Reproductive Technology- definition
• Assisted reproductive technology (ART): all treatments or procedures that
involve the in vitro handling of both human oocytes and sperm or of
embryos for the purpose of establishing a pregnancy. (Centre for Disease Control)
• These include:
• In vitro fertilization (IVF)
• Gamete intrafallopian transfer (GIFT)
• Zygote intrafallopian transfer (ZIFT)
• Intracytoplasmic sperm injection (ICSI)
• Surrogacy

5. What Exactly is Infertility?
• Definition has evolved over the years.
• Prior to 1975, a couple was declared infertile when the woman did not
conceive after five years of unprotected coitus.
• In 1975, the World Health Organization reduced the time to two years
and
• By 2005 further reduced it to one year.
• Infertility is “a disease of the reproductive system defined by the failure
to achieve a clinical pregnancy after 12 months or more of regular
unprotected sexual intercourse.

6. Public Health Importance
• Infertility is a major public health issue with devastating
consequences for the affected couple, family and community
• Culture
• High premium on children- (marriage security, social status, labor,
social security)
• Stigmatization
• Neglect
• Domestic Violence
• Disinheritance

7. Medical Ethics
Ethical Concerns in Assisted Reproduction
Autonomy Non- maleficence Beneficence Justice Safety Status of Embryo

8. Hippocratic Oath -The Physician’s Pledge
• AS A MEMBER OF THE MEDICAL PROFESSION:
• I SOLEMNLY PLEDGE to dedicate my life to the service of humanity;
• THE HEALTH AND WELL-BEING OF MY PATIENT will be my first consideration;
• I WILL RESPECT the autonomy and dignity of my patient;
• I WILL MAINTAIN the utmost respect for human life;
• I WILL NOT PERMIT considerations of age, disease or disability, creed, ethnic
origin, gender, nationality, political affiliation, race, sexual orientation, social
standing, or any other factor to intervene between my duty and my patient;
• I WILL RESPECT the secrets that are confided in me, even after the patient has
died;

9. Hippocratic Oath -The Physician’s Pledge
• I WILL PRACTISE my profession with conscience and dignity and in accordance with
good medical practice;
• I WILL FOSTER the honour and noble traditions of the medical profession;
• I WILL GIVE to my teachers, colleagues, and students the respect and gratitude that is
their due;
• I WILL SHARE my medical knowledge for the benefit of the patient and the
advancement of healthcare;
• I WILL ATTEND TO my own health, well-being, and abilities in order to provide care of
the highest standard;
• I WILL NOT USE my medical knowledge to violate human rights and civil liberties, even
under threat;
• I MAKE THESE PROMISES solemnly, freely, and upon my honour.

10. Ethics?
• Medical ethics is a system of moral principles that apply values to the
practice of clinical medicine and in scientific research. It is based on a
set of values that professionals can refer to in the case of any
confusion or conflict.
• Respect for autonomy- the rights of an individual to self-
determination.
• Non-maleficence do no harm.
• Beneficence- asking actions that serve the best interests of other.
• Justice- fair distribution of scarce resources

11. Issue 1- Management of Infertility in
Africa
•Is infertility a problem or a blessing in Sub-Saharan Africa?
•The five arguments against the application of infertility
treatment are
•Overpopulation- the China solution( one child per family)
•Prioritization of limited resources
•Prevention rather than cure
•Justice and equal access

12. Management of Infertility in Africa
• There are two arguments in favor
• Reproductive autonomy
• The huge burden of infertility in these countries
• Conclusion
• Increased investment in health care
• Reduction of the cost of ART
• Prevention of infertility.

13. Issue 2: Is ART ethical?
• Culture and Religion has the strongest impact on humans perspective of live.
• Major religions and their view on ART:
• The Catholic Church deems certain fertility methods immoral. In 1987, a document
entitled Donum Vitae (The Gift of Life), issued by the Congregation for the Doctrine of the
Faith.
• The Church does not accept IVF as a fertility method as it involves practices that not only
undermine the sanctity of life, but also replace the sacred procreative marriage act in the
bringing forth of life.
• IVF procedures often involve the deliberate discarding of embryos that show little promise
of surviving to term. This means that human life is potentially treated as a mere defective
commodity at its earliest developmental stages, and terminated.
• It is also clear that IVF replaces the marriage act with a laboratory procedure to engender
life. The husband and wife merely provide the “raw materials” – the eggs and sperm.
• Worse still, if “donor” eggs or sperm are used, the child is subsequently unaware of his or
her lineage, which could result in them lacking knowledge of possible inherited health
problems, or even the potential for siblings to unknowingly commit incest.

14. Issue 2: Is ART ethical? Contd
• Islam
• The basic concept in Islam is to avoid mixing genes, as Islam enjoins the purity of genes and
heredity. It deems that each child should relate to a known father and mother. Adoption is
not allowed, as it Implies deceit of children about their true genetic linkage and hereditary
• Since marriage is a contract between the wife and husband during the span of their marriage,
no third party intrudes into the marital functions of sex and procreation. A third party is not
acceptable whether he or she is providing a sperm, ovum, an embryo or a uterus- Donor not
allowed
• If the marriage contract has come to an end because of divorce or death of the husband,
artificial reproduction cannot be performed on the female partner even using sperm cells
from the former husband
• Cryopreservation : The excess number of fertilized ova (pre-embryo) can be preserved by
cryopreservation. The frozen pre-embryo is the property of the couple alone and may be
transferred to the same wife in a successive cycle but only during the validity of the marriage
contract.
• Multifetal pregnancy reduction : multifetal pregnancy reduction is only allowed if the
prospect of carrying the pregnancy to viability is very small. It is also allowed if the life or
health of the mother is in jeopardy

15. Issue 3: Use of Donor Eggs/Sperm
• Parentage: Who are the parents? Are they the ones whose genetic material
(sperm and egg) combine to form the child or the people who raise the child?
• Disclosure:
• Should children know that one or both of his or her (rearing) parents did not provide the egg
or sperm which brought them into being?
• Should children have access to the donor(s) (genetic parents)?
• Should genetic parents have visitation rights?
• Exploitation
• Should the donor be paid?
• Eligibility
• Same sex couple, single parents, elderly couple,

16. Issue 4: Embryo cryopreservation
• Left over embryos are cryopreserved, owners don’t get to use them after
all.
• Four possible fates for these embryos exist
• Thawing and discarding
• Donating to research
• Indefinite storage
• Donating the embryos to another couple for the purposes of uterine transfer
• In the event of divorce who gets custody of the embryo?
• All of these strategies have staunch supporters and detractors.
• Myriad of laws in different countries.

17. Issue 5: Surrogacy and Gestational
Carriers
• Surrogacy is defined as a woman who agrees to carry a pregnancy
using her own oocytes but the sperm of another couple and
relinquish the child to this couple upon delivery
• A gestational carrier, by contrast, involves a couple who undergoes
IVF with their genetic gametes and then places the resultant embryo
in another woman’s uterus, the gestational carrier, who will carry the
pregnancy and relinquish the child to this couple upon delivery

18. Surrogacy and Gestational Carriers
• Significant medical and emotional risks from carrying a pregnancy and
undergoing a delivery
• Child selling enterprise -Some also are concerned that the use of surrogates
and gestational carriers is a form of “child selling” or the “sale of parental
rights”
• Parental rights- Possibility of five parents. Genetic father, genetic mother,
Rearing father, Rearing mother, gestational mother.
• Exploitation and commoditization of children.
• Citizenship of the offspring(international surrogacy)
• Regulation of surrogates and gestational carriers varies widely from nation to
nation and even within regions of individual countries
• Renumeration

19. Issue 6: Preimplantation Genetic
Testing
• Preimplantation genetic screening (PGS) and diagnosis (PGD) offer the unique
ability to characterize the genetic composition of embryos prior to embryo
transfer.
• Given the recent successes of these technologies, the broader implementation
of this technology in the future is likely.
• Sex selection
• Designer children

20. Issue 7. Cost and Financing of ART
• Perhaps one of the most obvious ethical challenges surrounding ART
is the inequitable distribution of access to care
• The fact that significant economic barriers to IVF exist in many
countries results in the preferential availability of these technologies
to couples in a position of financial strength.
• The cost of performing ART per live birth varies among countries
• The funding structure for IVF/ART is highly variable among different
nations.
• Nigerian case: little or no health insurance, the cost of a cycle of IVF
treatment $3000-10,000, minimum wage- $50

21. Issue 8. ART in People Living with
HIV
•HIV infection should not be an exclusion criteria for access to
assisted reproduction.
•The HIV positive individuals should enjoy equal access to such
service and be evaluated using the same principles as applied
to the uninfected people.
•2001: The Committee on Ethics of American College of
Obstetrics and Gynaecology (ACOG) commented that ‘offering
ART to HIV patients is consistent with balancing respect for
autonomy with fetal beneficence.

22. Issue 9. ART for Unmarried and
Same Sex Couples
• The Japan Society of Obstetrics and Gynecology will soon be allowing
unmarried couples to receive in vitro fertilization treatments if they
want to.
• The Ethics Committee of the American Society for Reproductive
Medicine- Programs should treat all requests for assisted reproduction
equally without regard to marital/partner status or sexual orientation.
• Working paper in Nigeria- For treatment of unmarried couples, it was
unanimously considered to be unethical.

23. Issue 10. Possible Deleterious
Effects of ART
• Conflicting data exists about the risks of IVF on the developing embryo.
• Multiple studies have failed to find a clinically relevant association between
IVF or embryo cryopreservation and adverse maternal or fetal effects
• Other studies have suggested that infants of IVF pregnancies may be at a
small but statistically significant increased risk for rare epigenetic and other
abnormalities
• There is a general consensus that IVF confers a small but measurable
increased risk for a variety of congenital abnormalities including anatomic
abnormalities and imprinting errors as compared to the general population

24. Issue 11. Reporting Regulations
• The dynamic nature of ART and the rapid evolution of the field result
in constant paradigm shifts that require frequent and comprehensive
evaluation by professional organizations and society alike.
• Reporting requirements for ART pregnancy results, have been
mandated with legislation in many nations, though not accompanied
by legislation defining practice patterns.
• A detailed accounting for ART reporting and regulations across the
globe is available from the International Federation of Fertility
Societies(IFFS)

25. Reporting Regulation contd’
• Human Fertilization and Embryology Authority (HFEA), which
oversees and makes policy regarding ART in the UK.
• Presently, there is no law governing the practice of ART in Nigeria
despite the relatively long duration of practice. Most ART centers in
Nigeria and other developing countries operate based on HFEA
guidelines; this practice, however, is not optimal as there are several
contextual differences among the different countries.
• In Africa, only South Africa has legislated concerning ART to regulate
the practice of assisted reproduction.

26. Issue 12: Multiple Gestation
Pregnancies
• Because of the increased social costs and health risks associated
with multiple births, legislation or guidelines from professional
societies have been introduced in many countries restricting the
number of embryos that may be transferred per IVF cycle.
• Recent data suggests that single embryo transfer, coupled with
subsequent frozen embryo transfer, results in equivalent
pregnancy rates compared with the transfer of multiple embryos
and decrease maternal and infant health risks associated with
multiple gestation pregnancies.

27. Multiple Gestation Pregnancies
• Variability of legislation regulating IVF exists in different
countries and even states/provinces within a single nation.
• In some cases, these regulations or fiscal pressures result in
couples traveling across international border to obtain
treatments that are unavailable in their native country. This
practice, known as cross-border reproductive care (CBRC), is
thought to account for as much as 10% of the total IVF cycles
performed worldwide.

28. What Does the Nigerian Law Say?
• Code of Medical Ethics by Medical and Dental Council(MDCN)
• Part A, Item No: 23- Assisted conception and related practices
• While both sperm and egg donations in in-vitro fertilization are
accepted as ethically sound practices, in embryo donations,
gestational surrogacy or full surrogacy, the practitioner will need
to resolve ethical matters in respect of the following:

29. What Does the Nigerian Law Say? 2
• (a) Counselling and Consent of the donor in respect of:
• The willingness to donate .
• The desire to help infertile couples
• Psychological stress that may arise .
• Screening for genetic and infectious diseases to prevent transmission to
the recipient or offspring. .
• Informed consent to resolve social, psychological and legal uncertainties.
.
• The need not to be informed of the outcome
• The likelihood of not knowing the genetic offspring.

30. What Does the Nigerian Law Say? 3
• (B) The gamete or embryo processing .
• There must be the screening of family history for genetic diseases, HIV and other infectious
diseases including rescreening for HIV.
• In situations where embryos are mixed, genetic ancestry may only be determinable by DNA
testing.
• (C) The recipient is:
• Screened for uterine fitness and gestational capability .
• Screened-for psychological stress .
• Counselled that birth may not occur.
• Informed on the extent of screening done, particularly in case rescreening for HIV is omitted .
• Made to give informed consent on psychological uncertainties.
• Told of limit of information given to donor on the out come

31. What Does the Nigerian Law Say? 4
• (D) The Offspring
• There are options on the need for openness or secrecy with regard to full disclosure.
• For now in Nigeria, the principles applied in child adoption are best in the present
circumstances.
• (E) Monetary compensation for embryo
• There are ethical considerations on monetary payments in view of connotations of selling
and commercializing in the early form of human life.
• It has become necessary that the Laws of the country should make the provisions for
resolving this.
• Meanwhile the Medical and Dental Council of Nigeria advises that gamete or embryo
donation should be made as a voluntary service and not commercialized

32. The Nigerian Experience-Way Forward
• September, 2011- THE BRIDGE CLINIC LEAD DEBATE ON ETHICS OF IVF
• A working paper was developed:
• The session saw a deliberation on ten (10) key questions bordering on ethical considerations and
regulation:
• Is IVF ethical? -Most of the participants, except the Catholic Church, agreed that IVF is ethical
• Is ICSI ethical?
• Is gamete donation ethical? - Gamete donation is ethical as long as it has been established that the
couple have no chance of achieving a pregnancy with their own gametes and with the consent of the
partner.
• Is surrogacy ethical? -all participants concurred on the complexity of surrogacy arrangements and
concluded that surrogacy is not unethical but the legal and social implications must be addressed

33. The Nigerian Experience-2
• Is treatment of couples infected with the Human Immunodeficiency Virus (HIV)
ethical?- treatment of infected couples was ethical as science had enabled
procreation at minimum risk of transmission of infection to the child.
• Is treatment for the purposes of sex selection ethical? -the unanimous
submission was that sex selection for social reasons was unethical.
• Is treatment of unmarried couples ethical? -unanimously considered to be
unethical
• Is treatment of single women ethical? -unethical because it would support a
position that challenges the sanctity of the matrimonial union
• Is treatment of same-sex couples ethical?-extremely unethical and unacceptable
in the Nigerian context.

34. The Nigerian Experience-3
• September, 2017- public forum on Ethics in IVF organized by the
Ethics Committee of the Association for Fertility and Reproductive
Health (AFRH).
• AFRH President, Dr. Faye Iketubosin said:
“As an association, we are here to advise, we are trying to set a code of
ethics for practitioners which includes people having the right
qualifications, facilities and knowledge to engage in ART practices. The
resolution reached at the forum will be deliberated upon and an
acceptable ethical standard for the practice of ART in Nigeria would be
formulated.”

35. Current Situation
• A bill for the establishment of the “Nigerian Assisted Reproduction
Authority” is before the Nigerian parliament for consideration and if
passed will be a good starting point for regulation of ART practice in
Nigeria.

36. Conclusion
• Looking at these ethical issues from the perspective of a developing country like
Nigeria, access to ART remains the most critical problem. The safety, quality
assurance, and regulation of ART are additional ethical dilemma that needs to be
addressed.
• Other relevant issues are related to gamete donation and the concept of
parenthood in the “African” setting.
• There is an urgent need for stakeholders (fertility specialists, clients, professional
organizations, religious bodies, bioethicists, and government) in developing
countries to formulate cultural and context-specific guidelines to help address
some of these ethical dilemmas.

37. Reference
• Ethical issues of infertility treatment in developing countries G Pennings - ESHRE Monographs,
2008 - academic.oup.com
• Serour G.I., Serour A.G. Ethical issues in infertility, Best Practice and Research: Clinical Obstetrics
and Gynaecology, Volume 43, 2017
• Paul R. Brezina and Yulian Zhao. The Ethical, Legal, and Social Issues Impacted by Modern Assisted
Reproductive Technologies, Hindawi Publishing Corporation Obstetrics and Gynecology
International Volume 2012, Article ID 686253, 7 pages doi:10.1155/2012/686253
• The Ethics Committee of the American Society for Reproductive Medicine American Society for
Reproductive Medicine, Birmingham, Alabama Fertility and Sterility® Vol. 100, No. 6, December
2013 0015-0282/$36.00 Copyright ©2013 American Society for Reproductive Medicine, Published
by Elsevier Inc. http://dx.doi.org/10.1016/j.fertnstert.2013.08.042
• National Assembly of the Federal Republic of Nigeria. The Nigerian Assisted Reproduction
Authority (Establishment) Bill 2012. p. C4541-C50. Available from :
https://www.nass.gov.ng/nass2/legislation.php?id=1521 [Last accessed on 2015 Jul 15]
• The Revised Declaration of Geneva A Modern-Day Physician’s Pledge. Ramin Walter Parsa-
Parsi, MD, MPH1,2 JAMA. 2017;318(20):1971-1972. doi:10.1001/jama.2017.16230