Embryos for Donation: Where are the ethical boundaries?

November 25, 2012Carole 2 Comments »

Recently Dr. Craig Sweet of Sweet Fertility published a thought-provoking blog post entitled “Why Creating McEmbryos is Plain Wrong” which describes his misgivings with the alleged practices of another infertility clinic, California Conceptions, as reported in a recent LA Times article, “An Ethics debate over embryos on the cheap”. In the article, LA Times reporter Alan Zarembo describes the workings of an embryo donation program run by California Conception’s  Dr. Ernest Zeringue who offers embryo donation via an egg donor/sperm donor cycle that is shared among several couples. Couples pay a set price –roughly equivalent to the cost of a fresh IVF cycle– to participate in the program and each couple gets two embryos from the pool of fresh embryos created using donated eggs and donated sperm in their shared cycle. None of the recipient couples have a genetic link to the created embryos. Any remaining embryos are frozen pending assignment to other couples outside the original shared cycle, defaulting to a type of custody or perhaps ownership (?) on the part of the embryo donation clinic until they are matched with a recipient couple. If a couple fails to become pregnant from the pre-paid cycle, they get another embryo creation cycle at no charge with a new egg and sperm donor. A brief description of the embryo donation program can be found on the California Conceptions website, but it is a little short on details.

Dr. Sweet’s main concerns can be read in the original form via this link. I have roughly summarized his main concerns, as I understand them, below.

  • Dr. Sweet objects to describing embryos created from a donor/donor split cycle  as  “donor embryos”, arguing that it is not in fact similar to the more common practice of   embryo donation–IVF patients donating excess embryos from their own cycles to recipient couples for procreation. (This more “traditional” concept of embryo donation is in fact, the type of embryo donation service provided by Dr. Sweet’s company Embryo Donation International.)
  • When fresh embryos exist after a shared double donor cycle that are not “owned” by a particular couple,  and if custody and disposition decisions fall to the  company  creating the embryos–the company would in effect  “own” the embryos, a concept that Dr. Sweet strongly opposes; “Business, corporations or sole practitioners should never own life. They can help to maintain and foster the embryos but should not be responsible for disposition decisions.
  • Dr. Sweet acknowledges that the approach of creating embryos on demand for waiting couples “potentially saves some patients money and builds families, the ends do not always justify the means.”
  • Dr. Sweet also expressed concern that Personhood political activists would use the fact of deliberately creating embryos for donation to orchestrate a public backlash against IVF in general and embryo donation in particular. He calls for action on the part of ASRM and SART, “Our guiding societies need to take a very careful look at this practice and render a decision that will be fair and best to the greatest number of individuals.”

Dr. Ernest Zeringue responded to Dr. Sweet’s blog and provided some more details about the program as follows (from an Embryomail posting) :

“I am the owner of California IVF Fertility Center and direct the California Conceptions program.  Embryos that are left over after fresh transfers are matched to another couple in a subsequent cycle, often times before the donor ever goes to retrieval.  Recipients are aware there may not be embryos and are selecting an alternate profile.  There are patient driven blogs  where this is discussed in detail, a testament to the fact that the recipients know the details of the program – and quite well.  Donors are fully aware of the program and specifically consent to participate.  The logistics of this are complicated and take a lot of effort to coordinate on our end.  From the program’s inception, we have been adamant about not creating a bank of embryos and the selection of embryos is primarily driven by making physical matches to the recipients who have the opportunity to accept or reject a match.  We are by no means creating designer embryos, though we do apply a matching process similar to a woman picking an oocyte donor – she wants to match her physical characteristics so the baby looks like her.  Perhaps the semantics of “donated embryos” and “donor embryos” is something that gets people worked into a tizzy, but that doesn’t change the fact that we have embryos for recipient couples and “embryo adoption” isn’t an acceptable term.”

Okay, so what are patients to make of this debate? What should the general public make of these concerns?

The fact of creating embryos from donor eggs and donor sperm for a single recipient couple is a rather routine practice for most IVF programs. Shared donor IVF cycles are also not new in that two couples may agree to share an unrelated anonymous egg donor. In the shared egg donor example, eggs are shared (split between couples) prior to insemination and half of the donor eggs are inseminated by each of the male partners so that the recipient couple receives donor eggs inseminated by the male partner in each couple. For example,  embryos created using Mr. Smith’s sperm are transferred to Mrs. Smith and the embryos created with Mr. Jone’s sperm are transferred into Mrs. Jones. Any excess embryos created in each case belong to each of the recipient couple to do with what they will.

This shared egg donor cycle approach takes advantage of the fact that young egg donors often produce enough eggs for (at least) two fresh cycles and allocating the eggs at the front end to two couples, makes it less likely that there will be a lot of excess embryos created which may end up being stored in perpetuity at the end of the cycle.  The second –not inconsequential– consideration is that if the egg donor is shared, the costs of the egg donor cycle (stimulation drugs and ultrasounds, for example) are also shared, making the cycle less expensive for the recipient couples.

In the shared egg donor/sperm donor IVF cycles described in the LA Times article, what is different is that a pool of created embryos is shared among two or more couples. Costs are further reduced because several couples participate in the cost of one egg donor, one sperm donor and the lab costs of one IVF case. Furthermore, because the use of young donor eggs and sperm from donors (having high concentration, good morphology, good motility) makes the possibility of getting pregnant from these embryos greater than that achieved with IVF using a patient’s own gametes. So patients benefit from better quality embryos at lower cost (than usually paid for a donor cycle)  and are more likely to get pregnant in a first cycle (due to the typically higher quality of the donor gametes). From a patient’s perspective, this approach has obvious advantages.

One of the ethical questions that seems central to the double-donor shared cycle method for “embryo creation for embryo donation” is who owns the embryos that are not chosen  for immediate fresh transfer? Each couple is only promised two of the fresh embryos and any excess are kept by the program and matched to other patients at some point in the future. What is still not clear is whether without an assigned recipient, an embryo is “owned” by the clinic that created it using wholly donated gametes. Because none of the gametes come from the recipient couples, and donor gametes are chosen for recombination by the clinic, does the clinic own the embryos? This would be a departure in practice  from regular IVF using patient-contributed gametes where the couple who provided the gametes for their own use (or paid for donor gametes)  own all the embryos. Likewise, if a single woman uses donor sperm with her eggs, she still “owns” the embryo and can decide what to do with any excess embryos. Anonymous sperm and egg donors  forfeit any claim to and authority over the disposition of the embryos that result from their donation as part of the informed consent process.

What constitutes ownership of an embryo by a clinic vs. a temporary custodial arrangement? Embryo donation is handled privately in some clinics and embryo custody vs. ownership may be similarly unclear even in these more traditional models. Potential embryo donors discuss the dilemma of embryo disposition with their IVF physician who is also aware of other patients in his/her program that are looking to receive donated embryos. No one should be surprised that physicians in this position may orchestrate informal matches between the embryo haves and have-nots among their own patients.

Like with anonymous gamete donors, once the embryo donation paperwork is signed, the donor couple no longer has the right to dispose of the embryo as they see fit-in effect they no longer “own” the embryos. In the private program embryo donation scenario,  the donor couple might or might not be able to indicate their preferences over the type of recipient couple they would like to donate to, but the clinic ultimately makes those anonymous matches between recipients and donor embryos, not the donor couple. So in these cases, while the embryos were in “non-designated limbo”, and the clinic was making the matching and deciding about embryo disposition, did the clinic or practice “own” the embryos in the private embryo donation scenario? If so, this private clinic embryo donation example and what is described in the LA Times article is a distinction without a difference.  I have no idea how many clinics already handle embryo donation in this manner within their own programs but I know some do. In fact, I never gave this issue of temporary embryo donor “ownership” or “custody” by the clinic much thought before Dr. Sweet raised this issue in his blog. The examples  of private “in-house” embryo donation I am aware of handled this temporary responsibility ethically and with compassion toward both donating patients and recipient patients. Obviously, without any regulation or guidelines, that might not be the case in every clinic, so it is probably time to be asking these questions and calling for some consensus and practice guidelines.

The other major issue that arises is whether creating embryos for couples both matched and yet-to-be matched is commodification of embryos. Are we creating a supply of embryos to meet recipient demand and commercializing embryo donation?  Are we exacerbating the current problem of excess embryos?

We are still debating the size of the excess embryo “problem”. From time to time, I run across articles in which the author claims that there are 400,000- 500, 000 embryos in storage in IVF clinics in the US and then incorrectly concludes that these stored embryos are ALL unclaimed and just waiting for “adoption”. This is far from the truth. The vast majority –over 90%- are stored for the future use of the patients that created them and are not “up for grabs”. My own experience at the clinic level was that our list of patients who desired to be recipients always exceeded the list of patients who wanted to donate their embryos.  So I am very sympathetic to the plight of patients who need but can’t afford egg/sperm donor cycles or have exhausted the potential of regular IVF and now want to have the option to receive donated embryos.

Apparently, the means by which embryo donation is carried out is evolving beyond the simple traditional model which requires that we give some thought to what limits, if any, we want to put on the process of embryo donation. Should embryo donation be limited to donations from patient gamete-created embryos only? Is it ethically okay to design an (arguably) more cost-effective system to produce more “donor embryos” to meet the demand? I don’t have the answers. For me, the ethical way to handle embryo issues is  always to be fully transparent with all individuals involved and- as much as is possible–to look out for the best interests of the embryo’s future as a donor-conceived child.

I do think that ASRM and SART should take up these ethical issues and should ultimately- with input from providers, patients and the public–come up with some kind of consensus statement and guidelines for the ethical parameters around embryo  donation.

 

 

 

© 2012, Carole. All rights reserved.

2 Responses to this entry

  • It Is What It Is Says:

    As someone who is currently 35 weeks pregnant (can you believe it?!) through embryos anonymously donated to my clinic, I have wrangled with the ethics of how we treat and use ‘left over’ embryos in this country. In my case, the original couple used an anonymous egg and sperm donor which I believe made donating their remaining embryos back to clinic an easier decision for them. They clearly stated that the disposition of their embryos be the donation to another couple looking to create or expand their family. In doing so, the original couple was no longer required to pay the annual cryo-storage fee. My clinic does not have a formal embryo donation program. They do not charge for the embryos; they charge for an FET cycle. I know the clinic made their money on the original cycle that produced these embryos. If these had been embryos created and frozen from my own egg IVF, I would pay the same cycle fee for an FET.

    I’m off topic here (as part of my dilemma has been the cost that clinics charge for donated embryo FETs) and the thought of a clinic doing a shared cycle with a patient (a donor egg cycle where the patient received half the egg yield and the clinic received the other half) always made me uneasy (even if the clinic was trying to build a frozen egg bank).

    Of course, being of AMA, and once transferring 7 embryos in a single own egg cycle, I am not for government regulation of ART, but I do believe that the governing bodies ought to weigh in with an opinion/guideline. There seems to be much room for a big conflict of interest).

  • Carole Says:

    Dear It is What it Is,
    First, congratulations on being 35 weeks pregnant!! So happy for you! Thanks also for being a reader and commenter on this blog. I think this topic is really difficult. Just when I think ART is a settled medical discipline, something new stirs up new ethical questions. The in-house embryo donation program you describe is exactly the same sort of thing some of my programs did. No money was charged for the embryo per se, but an FET fee was charged to the recipient of the donated embryos. I don’t think anyone has done a survey but I expect this approach is fairly common since all programs that store embryos for patients have some patients who’d like to donate and often many more who’d like to receive some embryos. We also forgave storage fees in return for a disposition decision- any decision- for patients who abandoned their embryos. I was always troubled by the abandoned embryos -not because I felt they all needed to be donated–but because I didn’t feel that I or anyone else in the clinic had the moral authority to decide what should be done with these embryos. Anyway, I look forward to more discussion on this topic. I’d like to know how other patients feel about these tough issues. Carole

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