EMBRYO DONATION The New Program at the Mount Sinai Hospital CFRH by Kerry Bowman, Ph.D. and Michael Szego, Ph.D. - SUMMER 2011

EMBRYO DONATION - The New Program at the Mount Sinai Hospital CFRH

by Kerry Bowman, Ph.D. and Michael Szego, Ph.D.

Parents who have completed IVF often have a difficult decision to make: What should become of excess embryos created during IVF? Embryo cryopreservation (freezing) was developed in the 1980s and allows patients to store excess embryos not implanted during an IVF cycle. While the widespread use of cryopreservation has been overwhelmingly positive for patients, it often leaves patients with a difficult choice once they finish fertility treatments. Typically, women/couples are given the option to destroy, donate to research, or store excess embryos. By default many end up opting for long term and sometimes indefinite storage rather than one of the other permanent disposition options. Embryo donation is another, less practiced disposition option, that allows a woman/couple to give any excess embryos to another woman or couple. For many, embryo donation may be a viable disposition option worth serious consideration. Perhaps its greatest benefit is that it serves to help couples facing infertility to have a child, a notion that would certainly resonate with parents who have gone through the IVF process themselves. In this article we review the challenges of embryo donation and discuss the process and final outcome of an embryo donation program developed by a multidisciplinary team at the Centre for Fertility and Reproductive Health at Mount Sinai Hospital in Toronto, Canada.

Why do we hear so little about embryo donation?

Embryo donation is not widely practiced in Canada or North America. Of the fertility clinics that offer embryo donation, many report that no donations have ever been performed. This situation is likely caused by the lack of donors. Research consistently shows that patients who have frozen embryos are generally supportive of embryo donation, although few report that they would donate themselves.

Patients consistently remark that disposing of excess embryos is an extremely difficult decision. Studies examining the views of patients undergoing fertility treatments show that while most indicate that they would want excess embryos to be used, ultimately and eventually the majority opt to discard excess embryos. Surveys have indicated that patients who successfully conceive following fertility treatment are less interested in considering embryo donation as a disposition option compared to individuals who are early in their treatment or who have not successfully conceived. It is not entirely clear why a considerable number of people are hesitant to donate their excess embryos; perhaps the concern over having genetically related children that will be raised by a recipient/recipient couple is too great for many potential donors.

Such gaps between attitude and behaviour identify the need for deeper, more nuanced exploration of a concept or question. One of the reasons forwarded for this discrepancy is that patients beginning treatment may indicate an intention to donate as an idealistic plan rather than a set decision. Secondly, by the end of treatment, some patients report that their conception of the embryo has changed, in turn influencing their choices. Thus, patients often choose to keep their embryos in storage to avoid making a disposition decision at all. This storage often continues long after fertility treatments have ended.

Our philosophy toward embryo donation

Embryo donation programs can be modeled on either an adoption model or an anonymous model. In the adoption model, donors can play an active role in selecting recipients and the two parties can meet one another. In contrast, the identity of donors and recipients remain confidential and donors have no say in who becomes the recipient of their embryo in the anonymous model. At Mount Sinai Hospital’s Centre for Fertility and Reproductive Health, we have developed an embryo donation policy based on the anonymous donation model. Many embryo adoption programs describe embryos as having the same moral status as a foetus or baby. Our goal is to remain as morally neutral as possible with regard to the moral status of the embryo. As such we have chosen not to follow the language and process of adoption. On balance, we felt that the anonymous model is the most equitable for all the parties involved. We fully acknowledge there are a range of views as to the moral status of embryos and we fully respect these differences by allowing donors and recipients to make this determination for themselves. Furthermore, we found it important to consider that potential recipients represent a patient population who has usually endured many years of infertility, and embryo donation usually represents their final chance at pregnancy. We acknowledge there may be vulnerability associated with this history. Creating a program based on the adoption model would allow donors to choose recipients, leading to a significant power imbalance. Donors always have the option of not participating in the program; however, most recipients have few other options available.

Legal considerations

In Canada, the Assisted Human Reproduction Act was passed in 2004. The Act allows the disclosure of health information about donors to recipients; however, any information that could lead to the identification of the donor must be kept confidential without the donor’s written consent. Similarly, any information identifying a recipient or a recipient’s offspring would also require her/their consent. Thus, current Canadian regulations support the creation of an anonymous embryo donation program.

Ethics

We as a working group do not see embryo donation as ethically problematic in and of itself, yet it raises particular questions that need ethical consideration such as:

Prioritizing and matching
Potential recipient patients who may benefit from embryo donation include couples in which where both parties are infertile and single women. Potential recipients will first have to consult a fertility specialist. Women wanting to be placed on the embryo donation waiting list must meet the same clinical eligibility criteria as women wanting in vitro fertilization treatment.

Individuals accepted into the program will be prioritized on a “first-come, first-served” basis. Women at the top of the waiting list will be given the option to match for visible ethnicity and will have access to relevant family medical history from the embryo donors. If there is more than one embryo or embryo donation that matches the recipient, then the embryo(s) for implantation will be selected at random. The number of embryos selected for transfer will be determined by the physician according to their clinical judgment and in accordance with SOGC/CFAS guidelines on number of embryos to transfer in IVF.

Distribution of embryos
A commitment to equity is another fundamental principle guiding our embryo donation policy. We recognize that donated embryos are a scarce resource and that embryo donation may represent the last avenue for some women to become pregnant. As such, we have tried to develop a transparent process which will guide the distribution of donated embryos to recipients. Each recipient will be entitled to embryo transfer using donated embryos for a maximum of three (failed) cycles. A failed cycle is defined as an embryo transfer that did not lead to a live birth. In addition, given the short supply of embryos, there will be no further embryo transfers following a live birth. The recipient will remain highest on the waiting list until pregnancy and live birth occurs or until the patient receives three treatment cycles.

Privacy and confidentiality
One of the greatest ethical obligations associated with an anonymous embryo donation program is the assurance of privacy and confidentiality due to the significant implications for donors, recipients, and their families. A significant challenge has been to balance the rights and interests of donors, recipients and any resulting offspring.

Donors do have the right to privacy and control over their personal information. However, recipients also have the right to certain non-identifying information about the donors. For example, the donors’ family history of genetic diseases is essential information that recipients require to make an informed decision about whether to participate in the program. Furthermore, this information may well be relevant to the health of any offspring since this knowledge would constitute the medical family history of the offspring. Ethnic background will also be disclosed to recipients.

There may be circumstances where relevant medical information from donors or offspring may be highly relevant to the other party. For example, if a previously undiagnosed genetic condition was identified in the donor family, this information may be medically relevant to the recipient family and/or the child resulting from the donation. Since this is an anonymous program the donor and recipients would not know one another. However, we would act as the intermediary, and information that was medically relevant would be forwarded to the relevant parties. In such an event, our established embryo donation advisory group would meet to ensure the medical relevance of the medical information prior to giving it to the other party. The advisory committee would also ensure that sharing any such information would be consistent with the initial consent process agreed upon by the donor and recipient. For example, some recipients might decide, and can indicate, that they do not want contact – under any circumstances – even for relevant medical information.

Are offspring entitled to information about their genetic parents?
One of the ethical complexities with embryo donation is that we cannot possibly know, and in turn respect, the wishes of the unborn offspring at the time of the embryo donation. If we could we would ideally match donors who wish to remain anonymous with offspring who do not wish to ever meet their genetic parents, but this is simply not possible.

Currently, and similar to Canadian adoption practices, we allow the donors to decide whether they want to be contacted by offspring once they reach the age of majority. Donors may write a letter consenting to the release of identifying information to offspring. Of course the offspring must, in turn, be interested in learning about their genetic parents and must contact the clinic for any information to be released. Throughout western cultures and societies there is a growing movement towards transparency and openness in this domain. In many countries including New Zealand, the UK, and parts of Australia, identifying information from donors (of both gametes and embryos) is given to offspring upon request, regardless of any promise of confidentiality given to donors at the time of donation.

There appears to be a growing consensus that an offspring’s right to learn of their genetic origin trumps the privacy rights of the donor(s). We in turn ensure our clients are aware that current laws may change, mandating us to provide identifying information to offspring that is not currently required. Thus, individuals with a strong desire to remain anonymous over the course of a lifetime are discouraged from participating.

Consideration of maternal age
While the Centre for Fertility and Reproductive Health has no firm age restriction for women seeking help to become pregnant, a maternal age of 50 is the general upper age limit guideline. Women seeking a donated egg for conception must be 50 years of age or younger to be considered for the program. From a purely ethical perspective, we did not feel we could justify the determination of an appropriate age at which a woman should become pregnant; however, while age may have no moral bearing in our decision-making, it holds clinical relevance. In general terms, as a woman ages, the risks associated with pregnancy also increase. Thus age as well as other clinical criteria will be used to determine whether a woman is a candidate for the embryo donation program. Several ethical principles were considered when deciding this aspect of the policy. First, by not mandating a strict age restriction, we are respecting patient autonomy; it is ultimately up to the individual to decide the right time to become a parent.

However, we also recognize that as maternal age increases so does the risk to both mother and the potential foetus. As such, placing some age restriction is consistent with the principle of beneficence. By opting for a flexible age guideline, we are allowing physicians to use their clinical judgment while at the same time encouraging a conversation with patients about their preferences.

Embryo donation may well be an excellent choice for couples with remaining embryos and couples facing infertility. We have given careful consideration to the many factors involved and we are happy that the program has now been implemented.

About the authors:
Dr. Kerry Bowman has a Ph.D. in Bioethics, a fellowship in Cultural Psychiatry and a Masters degree in Social Work. Dr. Bowman is the Clinical Ethicist at Mount Sinai Hospital in Toronto and is also an Assistant Professor in Family and Community Medicine at the University of Toronto and teaches at the University of Toronto Joint Centre for Bioethics. Dr. Bowman lectures and publishes widely on ethics in health care, reproductive ethics, mediation, end-of-life care and cultural diversity. He has consulted extensively on these topics in Germany, South Africa, Iran and The People's Republic of China. Dr. Bowman is also a conservationist and founder of The Canadian Ape Alliance, is on the board of directors of The Jane Goodall Institute and is a consultant to The United Nations Environment Program.

Dr. Michael Szego is currently a fellow in clinical bioethics at the University of Toronto Joint Centre for Bioethics. He is also an ethics consultant for the Canadian Personal Genome Project at the McLaughlin Centre for Molecular Medicine. He completed a MHSc in Bioethics as well as earned a Ph.D. in Molecular Genetics from the University of Toronto. Before undertaking his doctorate, he completed an Honours Biology degree at McGill University. Dr. Szego's main research interests relate to research ethics and organizational ethics.