The Embryo Bank Dilemma: Reviewing the Issues, Historical Perspectives and Offering Potential Solutions
January 2nd, 2013 | 
Author: 
Craig R. Sweet, M.D
Reproductive Endocrinologist
Practice and Medical Director
Embryo Donation International
Introduction
In my last blog, “Why Creating ‘McEmbryos’ is Just Plain Wrong,” I wrote about my concerns regarding the creation of an embryo bank at a California clinic. In this follow-up segment, I want to re-state the issues, discuss the past history of embryo banking in the U.S., provide a list of recently written thoughtful blogs on the topic, offer possible solutions to the dilemma and discuss where we should go from here.
A “Reader’s Digest” version
California Conceptions (CC), as outlined in Alan Zarembo’s L.A. Times article apparently combined donor eggs with donor sperm and divided the resulting embryos among a number of embryo recipients. This process is commonly called a “split or shared donor/donor cycle” but was called “embryo donation” by CC. Any embryos remaining, after the recipients received their allotment, would be cryopreserved and owned by CC.
The road was paved with good intentions
I feel that CC was really trying to offer a cost-affective alternative for patients and that its true intent was to keep the size of its embryo bank as small as possible. Even with good intentions, however, it is quite likely that the embryo bank will grow. In addition, to sanction the creation of a small embryo bank will almost certainly result in the creation of larger embryo banks across the country. These banked embryos for commercial use are what I called “McEmbryos.” There also needs to be a clear distinction between embryo banking for commercial use and the process of banking one’s own embryos (i.e., collecting through multiple IVF retrievals) to be used by individuals to build their families in the future.
I still have three main concerns:
- I do not feel that embryo banks are appropriate and could result in a plethora of unintended consequences.
- I feel that corporations, businesses or physician practices should not own embryos.
- Lastly, the process of a “split or shared donor/donor cycle” should be called “embryo creation” or, at the very least, not called embryo donation.
This has happened before
An article by Gina Kolata in the New York Times in 1997 revealed that “ready-made embryos” were already being made for “adoption.” Columbia-Presbyterian and Reproductive Biology Associates were named in the article as providing “premade” embryos to patients. According to the article, most of the embryos were created when donor egg recipients backed out of the process, but the egg donors still underwent the egg retrieval; their subsequent retrieved donor oocytes were combined with donor sperm. Lori B. Andrews, a professor of law at Chicago-Kent College of Law, was quoted as having concerns about the supermarket approach to embryos while the clinicians thought it wasteful to not retrieve and fertilize the donor oocytes if the egg donors were ready for the retrieval.
In 2007, Center for Genetics and Society Senior Fellow and UC Hastings Law Professor Osagie Obasogie wrote an op-ed for the Boston Globe about a Texas center that had created an embryo bank. He was concerned about the “Wal-Martization” of human embryos, a phrase similar to my “McEmbryos.”
In November of 2012, in response to the N.Y. Times article, Jessica Cussins of the Center for Genetics and Society wrote an excellent blog on the topic, also following-up on the 2007 article by Professor Obasogie. The Texas center was eventually closed and was the subject of an FDA investigation, which eventually found that the creation of an embryo bank did not fall under FDA jurisdiction. John Robertson, Esq., wrote an excellent commentary on the topic in the Bioethics Forum in that same year.
Embryo banks have come and gone, garnering media attention and criticism and I believe it is finally time to set some ethical standards of care about them.
How New York decided to handle the embryo bank issue
Almost five years ago, the state of New York issued regulations for tissue banks and nontransplant anatomic banks, addressing the potential of creating embryo banks:
Embryos shall not be created for donation by fertilizing donor oocytes with donor semen, except at the request of a specific patient who intends to use such embryos for her own treatment. [NYS 52-8.7(h)]
Embryos were not to be created to store in embryo banks but only created at the behest of a specific patient and subsequently owned by that patient. Simply modifying the statement above to include “… such embryos for his/her own treatment,” would address the issue adequately, with the sentence potentially used by various organizations as they hopefully set ethical standards of care.
Potential consequences to the creation of an embryo bank
I have been called an alarmist by some for bringing up what I feel are the following potential dangers of having embryos banks in the U.S:
- If a small embryo bank is allowed to flourish, then large embryo banks will most certainly follow.
- Poorly designed and reactive legislation may be created on the state or national level as there may be further calls to regulate what are perceived to be “unregulated IVF facilities.”
- “Personhood” advocates may become further emboldened to win personhood for the embryos to protect them from becoming “McEmbryos.”
I don’t think these unintended consequences are that farfetched and need to be considered carefully should embryo banks continue unchecked.
My reluctant decision to come forward
About the last thing I wanted to do was to comment on another reproductive endocrine practice comprised of caring staff members dedicated to the care of their patients. I have been criticized for taking such a stand and accused of doing this purely for competitive reasons. In reality, I have been working with the American Society for Reproductive Medicine’s (ASRM) and the Society for Assisted Reproductive Technologies, (SART) since October of 2011, trying to elicit a set of guidelines prior to the writing of my blog. I far preferred to stay out of the limelight and let the “powers-that-be” decide what should be done next. When the L.A. Times article was published, it de-emphasized the ethical issues and potential unintended consequences of the CC embryo banking practice, so I felt I had no choice but to bring the topic up front and center.
Others responded to the discussion
Several other infertility professionals discussed the ethical issue in articles or blogs in the weeks following the L.A. Times piece. Excluding those that simply summarized the situation, I listed below what I think are some of the better blogs:
Supporting embryo banking
- Marni Soupcoff, Esq., “Marni Soupcoff on the sale of fertilized embryos: How much for the blastocyst in the window?”
Neutral to embryo banking
- Julie Shapiro, Esq., “Custom Made or Off The Rack?”
- Carole C. Wegner, Ph.D., “Embryos for Donation: Where are the ethical boundaries?“
- Elizabeth Swire Falker, Esq., “The Bizarre World of Embryo Banking. Where My Motherhood and Morality Meet”
Against embryo banking
- Andrew Vorzimer, Esq., “Get Pregnant With Built On Spec Embryos Or Get Your Money Back!”
- Jessica Cussins, B.A., “Embryos for Sale: ‘When You Want Them, How You Want Them, or Your Money Back”
- Sara R. Cohen, LL.B., “It’s not about the Money: Why we are So Concerned about a California IVF Clinic’s Anonymous Embryo Program”
- Mikki Morrissette, “Creating Embryos To Sell“
My thanks to all of the authors for taking the time to discuss the issue in an open forum.
Proposed remedies to the current dilemma
From the beginning, I have been offering remedies to the embryo bank dilemma. Although far be it from me to tell CC how to run its business, these are a few ideas I had to offer:
Only patients should own embryos-
No organization, corporation or physician practice should own embryos except in the most extreme circumstances, such as embryo abandonment. With embryo donation, it is most appropriate that the donor facility simply holds the embryos, with the donors still being able to request the return of their embryos, up to the point of transfer into the recipients, should a catastrophic occurrence take place, Attorneys refer to this as being a guardian, a conservator, or a temporary holder of goods. When presenting at the American Bar Association Family Law Section Spring conference in April of 2012, many of the attorneys there strongly supported the concept of conservatorship of the donated embryos over facility ownership.
If the embryos are returned to the donor, it seems appropriate to ask the donors to reimburse the embryo donation facility for all reasonable fees expended in originally obtaining the donated embryos and returning them to the donors. We have been running our embryo donation program this way for over 12 years and we encourage others to do the same.
Excess cryopreserved embryos could be owned by patients-
As best as I can surmise for CC, their business model is to recruit a number of embryo recipients and then transfer 1-2 donor/donor embryos into each recipient. I suggest that any remaining embryos be owned by one or more of the recipients and the entire cycle should not move forward until at least one patient agrees to take the extra cryopreserved embryos, should any exist. Extra charges could be levied to those that secure the remaining embryos. In this way, no embryos remain to create an embryo bank and the CC business model remains essentially intact.
Renaming the process-
The combination of donor sperm with donor eggs and then calling them donated embryos does not fit with the ASRM definition of embryo donation (Ethics Committee of the ASRM, 2009). Embryo creation is a far better term or “shared or split donor/donor cycle” is perhaps even more appropriate. Calling such embryos donated embryos debases the amazing gift that embryo donors provide when donating their embryos.
Who should set the standards?
SART has reviewed the concerns stated in my previous blog but I don’t think it yet has arrived at a
conclusion. My understanding is that the ASRM Ethics Committee is to take up the topic during the early months of 2013. As our main guiding societies, I believe they need to take the lead, develop position statements and provide ethical standard of care guidelines for all practices to use.
Once ASRM and SART have provided ethical standard of care guidelines, I will next request that the
Canadian Fertility and Andrology Society and the European Society for Human Reproduction and Embryology (I am a member of both) consider the topic and respond with their own recommendations if they see fit.
It is not out of the realm of possibility that numerous societies could collaborate to form a consensus, such as they did when they banned the support and publication of human reproductive cloning research.
Summary comments
So where are we now on this dilemma? SART has discussed the topic but summary statements are pending. The ASRM Ethics Committee will soon meet, with the embryo bank topic apparently on the agenda. Assuming the Ethics Committee feels the topic has merit, I am uncertain how long it will take for them to release a position statement. I am hopeful that “the powers that be” will be attentive in finding a compromise that will allow CC to continue to offer their skilled reproductive services while preventing the formation of an embryo bank, no matter the size, further clarifying who should own embryos as well as the definition of embryo donation as it pertains to the current situation.
I don’t know about you but I don’t really like the idea of “McEmbryos,” or the commodification and “Wal-Martization” of human embryos. Patients should own them and decide their destiny. I am hopeful that our guiding societies will do just that – guide us on this sensitive and important topic.
Special thanks:
Thanks to Grace Centola, Ph.D., for helping to find the New York State statutes pertaining to embryo banking.
Thank you to Jessica Cussins for her blog on the topic, the reference by Professor Obasogie and her followup on the now closed Abraham Center for Life.
References:
Ethics Committee of the American Society for Reproductive Medicine. American Society for Reproductive Medicine: defining embryo donation. Fertil Steril. 2009 Dec;92(6):1818-9
.
Posted in ASRM, cryopreservation, embryo adoption, embryo donation, embryo donor, embryo recipient, embryos, law, legal, RESOLVE | 
Tags: ASRM, cryopreservation, disclosure, Embryo, embryo adoption, embryo donation, embryo recipient, embryos, law, legal, legality, RESOLVE
24 Responses to “The Embryo Bank Dilemma: Reviewing the Issues, Historical Perspectives and Offering Potential Solutions”
Dear Dr. Sweet,
Thank you for all the time, thought and dedication you put into discussing this important issue in an open forum. This is an incredibly important issue, and I hope many people are taking the time to consider it.
Being a person who believes strongly in reproductive freedoms, it is difficult for me to be critical of anyone’s choices when it comes to reproductive technologies. However, that is the exact crux of the matter – it is the reproductive freedoms of the users of assisted reproductive technologies that we must safeguard, and not the freedoms of the medical community to make embryos as they see fit.
Thank you Sara.
I do truly feel that California Conceptions really didn’t want to just make embryos. They just wanted to help their patients. At issue are the unintended consequences of their decision. No matter what they do, they will create an embryo bank that will be owned by CC. Unless someone can provide an argument against, I simply feel embryos should only be owned by patients and not a business, corporation or physician practice. Who else should be deciding their fate than those that took on the responsibility of their creation?
Thank you Dr. Sweet for this well researched and supported argument against the banking of embryos. It seems to me that the infertility profession must be extraordinarily careful with any appearance of treating the creation of embryos callously. And even if that is not the intent of embryo banking, no matter how small the bank, the hint of impropriety could do great damage to the profession, and most important to the legends of infertility patients.
Dawn Johnson
Creating a Family ~Education and support for infertility and adoption
Dawn:
I totally agree with your concerns. The potential for harm to women’s health care and the infertility world could be great if embryo banks are taken up as a rallying cry to those that would prescribe personhood to embryos.
Thank you, Dr. Sweet, for writing such a well-researched compilation of this issue, from your perspective as well as many others. I have written my own thoughts on this for the Choice Mom community of single women who use embryo donation, among other methods, to build families. Here’s some of what I said: “We like to trust those businesses who help us build our families using the amazing new methods of reproductive technology. But, we’ve heard stories of how those technologies have been misused, even by well-meaning doctors. I’m not in favor of letting a commercial business decide which lovely egg donors and which prolific sperm donors they will combine, unsupervised, to create the best package of fully related children The Market Wants. I am highly in favor of embryo donation for the Choice Mom community, but with parameters that keep our eventual offspring in mind. As always, how will they feel about their origin story?
Mikki:
Thank you for your very thoughtful comments and your wonderful blog.
While I don’t feel that California Conceptions (CC) was making any embryos without clear consent from recipients regarding the choice of the egg and sperm donors, we absolutely run the risk of others creating “McEmbryos” placing egg and sperm donors together based on market research, personal preference all significantly focused on the greatest likelihood for profitability. If all the cryopreserved donor/donor-conceived embryos find a home, I have less to complain about. What happens, however, if some of the cryopreserved embryos are never chosen? Who will decide their fate? Who should decide their fate?
Dr. Sweet – I first want to thank you for your time, dedication and bravery for writing a well-researched blog from your perspective as well as sharing the ideas and thoughts of the many others you have referred to in this piece.
The practice of creating “ready-made embryos” has been going on for a very long time, at least to my knowledge since 1997. Last year (2012) the subject came up again and tongues were wagging over the fact that California Conceptions was reportedly creating embryos from donor eggs and donor sperm and then taking those embryos and distributing them to their embryo recipients and saying this was “embryo donation” when really it’s not. In fact, what I think California Conceptions is really doing is creating embryos from donated eggs and donated sperm with NO SPECIFIC RECIPIENT PARENT IN PLACE which means this clinic is creating embryos (picking and choosing genetics), banking them, and then selling them to patients with a money back guarantee.
Also, from my understanding is that any left-over embryos that remain from any cycle at CC are cryopreserved, placed back in the freezer and are owned by California Conceptions. Not the egg donor, not the sperm donor, and certainly not the recipient parents.
What does this mean?
This means that the original parents of these embryos are the CLINIC not the recipient parent.
I was one of the many who were contacted by a reporter from the LA Times to ask my opinion about the practices of “ready-made” embryos. I gladly spoke to this journalist as I felt I had something worthwhile to say as the Founder of Parents Via Egg Donation and as a mother via egg donation myself. Unfortunately none of what I had to say made it in the LA Times piece and it’s a shame really because I think as a parent and a leader of a rather large egg donation community our thoughts and opinions had validity.
First of all let me say that you can’t put a price on a life, however, we all as patients pay a lot of money for to clinics and agencies to help us with creating our families. I can understand why the program at CC would be incredibly inviting because of the price structure but my biggest problem with all of this is that from what I am to understand this clinic is selecting egg donors and sperm donors and putting them together and then SELLING those embryos. However, this really sounds like to me like “pre-destination embryos” and in my book that’s a problem. I also understand that CC was trying to offer a better solution – or a more economical solution as an alternative to patients. However, I don’t care if the intent of the embryo bank was to be small or large it’s still a commercial embryo bank and that’s not okay. These folks are not storing left over embryos from previous patients who are trying to decide if they want to add to their families, these are embryos to be sold.
I think we need to be clear – this is NOT embryo donation. It’s not. It’s not. It’s not. These are embryos that are created, hand-picked, & specifically created by California Conceptions. It’s akin to a mail order bride, but it’s a potential mail order kid.
Doesn’t that leave a bad taste in your mouth?
The saddest piece to all of this is that there are hundreds of thousands unwanted cryopreserved embryos that are on ice all across the USA. Over 500k to be exact. My guess is that many of these embryos could be donated to couples all over the globe if the donating parents knew that donation was clearly an option. Education is key.
Aside from the whole disgusting commercialization piece to all of this what about the kids? Hasn’t anyone thought about the kids? If a cycle split between 3 couples creates three, four, five children, all these children are going to be genetic siblings who are NEVER going to know about one another. And that in my book is irresponsible and unconscionable.
In closing I am all for thinking outside the box. I am open minded about how family can be or should be created. However, this program I don’t think has thought this through and if they have shame on them. Nothing about this program can be justified, morally or ethically.
As the leader of PVED I work very hard to bring egg donation to the forefront and present it as not being “weird” or something from outer space. I justify what we do to those who would like to ban egg donation, embryo donation, and anything third party every single day. I answer questions daily in regards to egg donation and is it really creating designer babies, and is egg donation or embryo donation ethical. However, its stuff like this that will indeed give those who support personhood a leg to stand on and will indeed bring regulation faster than you can create an embryo.
Physicians should not be allowed to intentionally create and market embryos. There are so many things we already customize – houses, landscaping, boats, cars, — children should not be one of them.
Marna:
You make some wonderful points. Your perspective is valued and highly respected.
Continuing your thinking outside the box, there are compromises that could entertained by California Conceptions would allow them to care for their patients with few changes. All they have to do is to make certain that all excess cryopreserved embryos are owned by one or more of the recipients. I think it is really that simple.
The points made regarding the genetic siblings not likely to connect is a concern that is ringing true throughout the donation word, thus the push towards open identity options. Let’s be honest, though, CC isn’t the only one that could be criticized on this issue.
I suspect what leaves you with such a bad taste is the minimal level of respect the embryos seem to garner. It is as though we were dividing home-made cookies amongst a group of three, four or five with the extra cookies kept by the original baker to hopefully be given to others at some later date. I would not want my embryos to be treated as such and I can’t help but wonder if the caring physicians at CC might feel the same as I if it was their genetics that were used to bake the cookies in the first place….
Thank you Dr. Sweet for bringing this conversation to a public forum. I share the concerns shared by others in this forum. As I continue to think about this topic, I only have a few comments to share.
1. The CC option is, in part, a market response to a rare resource. Embryos that are available for adoption to patients represent only 2.3% of all the stored embryos in the US– see this Rand Study http://www.rand.org/pubs/research_briefs/RB9038/index1.html The vast majority of embryos (over 88%) are stored for the patients who created them for their own use and will likely never be donated. As a lab director, I found this to be true on a smaller scale at every lab I directed so I believe these percentages. Greater education may help in some clinics but we took great pains to make sure all options were explained and available to our patients and still only a relatively small number chose to donate their embryos to other patients. We need to work harder to ensure affordable access to high quality infertility treatments for all patients–this would make these “bulk buying” arrangements to acquire embryos unnecessary and unappealing.
2. I agree that ART labs/clinics/professionals really need to stay away from practices that result in “owning” embryos. It’s hard (impossible?) to thread that needle without being subjected to accusations of commodification of embryos.
3. Finally, I always circle back to one nagging issue. All of my career in ART, our focus has always been solely on satisfying the immediate needs of our patients to achieve a pregnancy.In most cases, we were simply bypassing natural barriers by providing IVF services so couples could conceive their own children-with a little help in the lab. Then we worked with donor gametes that couples chose to conceive their own “intended” children. We profit from all these interventions. Now clinics are going further to address our client’s needs –supplying unrelated embryos to couples–either from embryos donated by other patients or embryos created with the intention of being donated or adopted- and in some cases having left over embryos. I think these latter “embryo matching/ embryo donation” advances place a greater burden on the IVF programs to give some thought to providing these services within a framework of transparency– so that donor-conceived children have an option in the future to have some information about their biological origins. IMO, we need to think about embryo donation registries as well as sperm and egg donor registries. Donor conceived children are speaking up –loudly and angrily in some cases- about the fact that at the time of their conception, no one gave any thought to their future emotional or medical needs for having some connection to their biological roots. Due to poor records and preferential recruitment of donors who favored no strings donation, kids often have no realistic chance of finding their bio-relatives. I don’t think we have a right to decide for every donor-conceived child in advance that they don’t need this access. I think that is one step too far. I would like to see this discussion about embryo donation also include some consideration about the place of registries as we move forward full-speed with providing more unrelated embryos to more couples- in one fashion or another.
Dr. Sweet:
I appreciate the challenge to articulate why the practice of embryo creation and banking as described is objectionable to me as a mental health professional, family advocate, and mother of an adult son conceived long ago through ovum donation.
The litmus test on ethics in reproduction should begin with the question “what do we tell the kids? What is this story? How do we build families non-traditionally that make psychological sense?”
The story we can tell our children thus far with our various methodologies of reproduction is that people who plan to be parents select gametes and a uterus. They select medical facilities. Gamete providers are chosen for various reasons, both emotional and simply logical, but are chosen by PARENTS who don’t have children yet. They make choices about who they are going to make a baby with, just as people do who conceive in the bedroom, but removed from one’s own genetics. We can tell our kids that “mom and/or dad decided this or that and we got you.” Those decisions are the first decisions parents make on behalf of the children they don’t yet have.
Individuals who are donor conceived with sperm from cryobanks are returning to those cryobanks by the hundreds to request information or contact with previously anonymous donors. Can we learn nothing from history? What of the children conceived not by their parents but by a corporation with little or no interest in the psychological outcome?
In truth, those of us who have been thought leaders in this field, are just now figuring out the story to be told to offspring of “conventional” embryo donation. It’s a tough story. The embryo was conceived by a family who (usually) had children and then gave the (leftover) embryos to someone else. There are lovely ways to frame this story, as it is indeed always altruistic, and with the intent to give someone the opportunity to parent whose efforts have been otherwise thwarted. But there are issues of full siblings raised apart, issues of the randomness of laboratory procedures, and other issues that require extreme sophistication and conscientiousness on the part of both donating and receiving parties to address with any children in either family.
If you take the above issues and add to it the random selection of gametes chosen by personnel, not parents, and the issues of “ownership” and rights and everything that has been previously mentioned and we have a scenario that is extremely difficult to help children understand. The story has to make psychological sense and this story cannot because it does not.
It is my opinion that this practice is not contributing to the creation of healthy families.
Carole LieberWilkins, M.A.
Licensed Marriage and Family Therapist
Los Angeles, CA
Carole LieberWilkins:
I couldn’t agree with you more. While I do suspect any child conceived from an embryo bank would inevitably be loved and cherished, I too would wonder what my parents were thinking when they chose my genetic parent’s characteristics over all others. Above all, I would wonder about my genetic parents and my potential full siblings living other lives separate and detached from mine.
Carole,
I think registries would be welcomed by most clinics, though difficult if not impossible to administer. People move, change numbers, and don’t respond to phone calls. How is the registry funded so they can maintain contact with donors? Does the registry simply release a name or a social security number? What’s the clinic’s responsibility to track donors into the future and could they end up punished or sued if they don’t maintain contact? To compound this issue, most donors prefer not to be contacted. We ask about future contact using multiple questions and scenarios and I’d say that 90% or more say they do not want to be contacted. If regulations were to force this contact, it could certainly reduce the number of people willing to donate. Everyone seems to look at this from the perspective of the children, and I agree that needs to be considered, but the wishes of the donor should not be disregarded in the process. A tough topic and would make for a great blog post by itself.
Carole:
Regarding the 2.3% of all cryopreserved embryos donated to patients in need statistic, I think it is a bit low. Most publications on the topic quote a higher percent but certainly less than 10%. In my separate practice, Specialists In Reproductive Medicine & Surgery, a recent review revealed that 19% of our cryopreserved embryos were donated to patients in need. I think this is due to our hard work in educating the patients very early in the ART process as well and repeatedly in the future years when they really have to make the difficult disposition decisions. I should also state that we are a “non-destruct facility” meaning that we offer all options for the cryopreserved embryos other than discarding them. All IVF patients are well aware of this before they start the process and I have never received push-back” from patients who feel their own embryos are indeed precious and that they would never consider discarding them. Unfortunately, we know better. I believe continued cryopreservation, donation to the laboratory for QA work, donating to human embryonic stem cell research and donating the cryopreserved embryos to patients in need are plenty of options to provide the patients. It has always bothered me that one-half of the cryopreserve embryos would not be used by the patients who created them with a total of one-third being abandoned or discarded. I feel we need to gently guide patients toward better choices and what we do seems to work.
The concern regarding registries is important but very complex. It would appear that we are not going to form any type of registry anytime soon unless it is legislated at a state or national level. So many questions would need to be asked and answered before we could take this on. Your excellent moderation of this same concern on LinkedIn’s Embryo Donation Network garnered the largest number of comments to date (n=57) from people from around the world. We could learn so much from our peers in the Netherlands, Sweden, Finland, Austria and the United Kingdom. A wonderful review on this topic is available at the Social Science Research Network with a paper written by Sonia Allan titled “A Cross-Jurisdictional Study of Regulatory Requirements and Practice Regarding the Recording of Donor Information and Its Release to Donor Conceived People.”
Let me make it clear, however, any criticism levied against the California program regarding the lack of a registry should probably be levied against the vast majority of egg/sperm/embryo donation programs.
Dr. Sweet:
Thank you for the excellent post. I want to start off by saying that I fully support family building options using both donor sperm and donor eggs, and that I also support industry creativity in achieving lower cost options for patients. However, as with any treatment options, there are some moral, ethical and legal boundaries that should not be crossed. In that vein, I would like to discuss two of your points in more detail.
Terminology:
Embryo donation, in which excess embryos remaining after the conclusion of treatment are donated by former patients to others, has become a very attractive family building option for many intended parents. Some prefer embryo donation due to the relatively low cost; others see using existing embryos as a more morally acceptable option to using technology to create new embryos. However, California Conceptions’ model is not based on “embryo donation,” but rather “embryo creation.” Yet, the clinic persists in defining its model as “embryo donation.” The clinic’s website is filled with references to “embryo donation” and absent are references to the actual use of “egg donors” or “sperm donors” in their protocol. A few examples:
1. “But unfortunately, both traditional adoption and using an egg donor are very expensive and time consuming ways to build a family, especially after spending thousands of dollars on failed IVF cycles. Using Donated Embryos is Affordable and Combines the Best Aspects of Egg Donation with Adoption.”
These two sentences certainly give the impression that California Conceptions is not using egg donors in its program. This is not accurate–the model, as described by Dr. Zeringue is based entirely around egg donation.
2. “Anonymously donated embryos are a very affordable alternative to egg donation and adoption with similar benefits.”
This sentence clearly states that embryos are being donated. In reality, the donors are providing only eggs and sperm. While some may say this distinction is meaningless, in reality it has tremendous import. Those intended parents who are morally opposed to the creation of new embryos would have no way of knowing that the clinic is doing exactly that.
3. “Much like an anonymous adoption, embryos from IVF procedures are donated to couples and individuals wanting to have a baby.”
Again, the language is (deliberately?) phrased in such a way so as to mold the program to the traditional embryo donation model where a couple undergoes IVF and then donates their excess embryos.
4. “This donor embryo transfer is similar to using IVF with an egg donor for getting pregnant.’
No, California Conceptions model is not “similar” to using an egg donor; it IS using an egg donor. Why the need to hide that?
5. “Let us know how ready you are to proceed with embryo adoption.”
“Embryo Adoption” has been a term used exclusively to describe the donation of already-existing embryos. Even the most fervent crusaders determined to give every frozen embryo a chance at life don’t use the term “adoption” in relation to eggs or sperm.
6. “Do you have any strict requirements (other than healthy donors) when it comes to matching embryos to your profile?”
This language of matching “embryos” implies that embryos—and not eggs and sperm individually—are being matched.
Whether California Conceptions is deliberately misleading patients or whether the deception is just poor marketing choices on their part, the bottom line is that the potential for patients to be misled exists. I have heard the claim that California Conceptions fully explains the program to all patients—even if this is true, it does not balance out the potential for deception in their advertising materials. The double donor method used by California Conceptions is a perfectly legitimate family building option. Thus, I have to ask California Conceptions–why the need to disguise the method as something else?
And I have to wonder, if the marketing materials aimed at intended parents are deceptive, what about the marketing materials aimed at donors? Are donors providing full informed consent? Those of us in the industry know how dangerous it can be when donors are not fully informed of the process. Not only is lack of informed consent harmful to the donor, but it is harmful to the intended parents. Consider the situation in Options National Fertility Registry v. Dr. Michael Allon, Jud.Dis.190th, Harris Cty, TX (2005), where the egg donor did not realize that her eggs would be split between two couples. When the egg donor discovered this, she successfully sued to stop the donation to the second couple, even though the eggs had already been fertilized with the husband’s sperm. These are the kinds of situations that can arise when a clinic does not obtain proper informed consent from a donor.
Embryo Banking:
New York State has the right idea. Embryos should not be created except at the request of an identified patient(s). To do otherwise cannot be justified because the physician’s role is to assist in reproduction, not to usurp the process. Courts have repeatedly recognized embryos as something special….not people, but not just ordinary property either. And there are some very practical problems that could arise from a clinic or physician owning embryos. What happens if the clinic disbands? Who gets the embryos? Would the embryos be auctioned off or given to a creditor in case of bankruptcy? Would the physician’s family inherit the embryos after his death?
You have provided some techniques for California Conceptions to adopt to ensure that all embryos are owned only by patients. Alternatively, an option would be for the clinic to destroy the embryos that have not been distributed to a patient. While this would not be financially advantageous to the clinic, and some would argue is a waste of resources, it is an ethically acceptable alternative when no patients are willing to accept responsibility for the excess embryos.
California Conceptions, I urge you to join ASRM/SART. If you feel that your model is ethically appropriate, then you should be teaming up with ASRM/SART to develop guidelines for such embryo banking models, rather than shying away from industry self-regulation.
You take single sentences out of context and wrap new meanings around them. We offer both traditional embryo donation and donor/donor embryos. The website does not make a clear distinction between the two as it was written when the program was very new. We clarify all options when talking with patients as both options will be available to them. Honestly, the website needs to be updated, but that’s not the same as intentionally misrepresenting what we are doing. Patients know clearly what’s being done when they contact us and definitely know by the time they have a transfer. Fortunately, our patients are smart enough to get all of the facts before blindly following a web page. You’ve spent more time micro-analyzing the sentences than I have. I’ll be happy to consider your interpretations when we make updates as it can help make for a better webpage.
Your comments on embryo banking make it clear you haven’t read the previous posts. Egg donors are not starting medications until there are recipients there to receive them. As a result, they are not created without identified parents. You then suggest we destroy the embryos rather than match them to another couple? I hope most people reading a blog on an embryo donation website disagree with you. What happens to any embryos stored at a clinic if that clinic goes out of business? Somehow you think they go to auction or a creditor? You know better than that.
Our donors know of the donor/donor program and have the option to not participate. They can still donate for a couple needing an egg donor outside of California Conceptions.
I have initiated contact with ASRM and provided information about my program. I have also offered to provide any additional information to the committee and participate in any discussions on the topic of embryo donation or donor embryos. The meeting is not an investigation of my program by ASRM as has been suggested.
I would have time to revise the website if I didn’t have to spend so much time responding to people posting misguided opinions about what I’m doing. As I said, our patients know what we are doing and are grateful for the opportunity. That’s what is important to me.
Dr. Zeringue:
I agree that discarding any excess donor/donor embryos would not be an option I would like to see used. Would you consider having any of these embryos immediately owned by any of the recipients rather than banking them and trying to find other recipients in the future?
You describe your facility as offering both (shared/split) donor/donor embryos and the more conventional embryo donation option in which the embryos were actually donated from patients with excess cryopreserved embryos. Would you be willing to provide any statistics regarding the actual number of the two separate procedures performed in 2012? If the conventional embryo donation procedure number was substantial, perhaps some of the criticism levied would be softened by knowledge.
I agree that the ASRM Ethics Committee is meeting to discuss the embryo bank issue in general as this practice has been attempted before. It will be up to them to decide if now is the time to come out with a position statement regarding the process. If you feel singled out, I will apologize. In my recent blog, I tried to find instances where this had happened before. One must be clear, however, that your facility has (inadvertently) become a lightening rod regarding this issue and focus on your facility is inevitable given the L.A. Times article and the blogs that responded to its content.
Catherine:
You bring up some very perceptive points. Your concerns are clearly aimed at the vulnerable infertile patient.
My understanding is that the egg donors are aware of the business model the California facility is using. I have yet to see a contract so I can’t personally write on this point. Perhaps the facility would be willing to share their contracts/consents with the Legal Special Interest Group for their review. I understand the sperm donors are obtained from a national sperm bank and are probably not made aware of this potential use of their sperm from the get go. Once again, contracts/consents would need to be reviewed but my guess is that the embryo bank concept is too new and the contracts/consents probably haven’t had time to be modified.
It would sadden me to have any clinic destroy the remaining cryopreserved embryos rather than create an embryo bank. I would be torn with deciding the lessor of two evils. While a personal choice, I would tend to feel the destruction of the excess embryos would be a worse choice than creating an embryo bank, I am not sure such a decision really needs to be made. Simply making certain all the fresh and cryopreserved embryos are owned by potential recipients is all that is needed. Once done, the California facility can continue with its business plan and still maintain the highest ethical standards of medical care for their patients.
Dr. Sweet,
Thank you for initiating this conversation. The banking of embryos is a “hot” topic that needs to be considered carefully.
I must admit, I have concerns regarding the creation of embryos without a destination. Just saying out-loud, “Embryos created by a business first and then finding an intended parent second” is unsettling to me.
My field involves educating infertility patients to effectively advocate for health insurance benefits. This includes lobbying at the state and national level to ensure all infertility patients have access to the health care they need. The topic of embryos is highly sensitive within this arena and increasing the controversy to the subject does not help our efforts to secure legislative support. And while we propose infertility health benefits are pro-family, the practice of creating embryos without a prospective parent creates a factory feel rather than a gift from medical technology.
I understand the ASRM Ethics Committee will be discussing this subject soon. It is my intent to share my concerns with them and hope they will strongly consider the advocacy perspective.
Thank you again for starting this conversation.
All my best,
Davina Fankhauser
Fertility Within Reach
Davina:
Your hard work as a patient advocate is so very appreciated. I personally admire what you do for so many patients.
In defense of the California program, I don’t believe they are creating embryos first and then finding recipients second. I believe they are getting a group of recipients together to agree to use specified pair of egg and sperm donors before moving forward. Perhaps it is even possible more than one sperm donor is being used. This is no different than what is done at many programs that use a split or shared cycle protocol. My concern, however, is with the inevitable embryos that are left over from the process should an excess of fresh embryos be present after matching them to all the initially prepared recipients. Unless those excess cryopreserved embryos are owned by the recipients, an inevitable embryo bank is created by the facility with the embryos owned inevitably by the facility. This is my greatest concern.
Dr. Sweet, you must love the different tone of the responses to this post compared to the previous one. In a previous blog you made the assertion that the many negative posts seemed organized or intentional. In this blog, it’s now the opposite response and seems to be biased based on your notions of banking and ownership with a slant to your previous “designer baby” ideas. Are any of the responses here invited by you? Also, any ideas about the opinions of REI physicians?
Your topic is supposedly about embryo banking, however after many of the comments you discuss California Conceptions. I am at least happy to see that you have a more informed opinion of our services compared to the previous post. Still, much of the blog and responses are dedicated misconceptions about what we are doing. The articles you quote do not really support your arguments. The 1997 one talks a little about selecting donor characteristics but by the end it becomes clear the embryos from donor sperm and donor eggs were formed only when a recipient backed out. The doctors and embryologists interviewed didn’t seem to find this unacceptable. Of course you only quoted the attorney in the context that is suits you, but please note that that comment follows a paragraph about traditional embryo donation. She goes even further to call the process embryo adoption. Not a great post to quote here. The 2007 posts about Jenalee Ryan and the Abraham Center of Life in San Antonio, Texas have their facts wrong. Read the original articles about her program, or better yet, talk to her. Her program never started and there wasn’t a bank. The FDA showed up at her house to investigate her compliance with the FDA’s regulations. Since her service was actually a matching process between a couple using donor eggs and subsequent recipients of the left over embryos, there was nothing to investigate. Additionally, since the custody of the embryos transferred from the original couple to her customers who would pay a fee for the matching services, the program would pass your ethical test of always having an owner. Lastly, the 2012 blog by Jessica Cussins is just an uninformed rehash of your first blog. The facts are inaccurate and make accusations that are defamatory to say the least. It appears that your best references, and many of your commenters on this blog, are attorneys with an opinion and disregard for actual facts. If you want to avoid government regulation, I’d suggest you find a better circle of internet friends.
There is a trend in the comments that infer we are creating embryos “for sale” without intended parents ready to receive them and that we are storing extra embryos that we “own” and can choose to do anything with them without ethical regard to the embryos. You imply that saving embryos and matching them to another couple is still a bank and this is a bank will open up the doors for regulations and large warehouses of embryos. In making several very good points, most of which we agree upon, you are making several very big leaps and your followers have taken these assumptions at face value.
As we discussed, we differ greatly on what is a bank and what isn’t. You feel because of your “take back” policy that you don’t have a bank of embryos. In a financial bank, the bank doesn’t own the money you deposit. Is it really ownership that defines a bank? We call a sperm bank a bank because they have stores of sperm. Is there a clear owner? Wouldn’t the “bank” own them since they in turn sell the vials (presumably for the cost of procuring and processing the sperm as gametes can’t be sold)? Most people want to treat embryos differently, and ASRM holds that embryos should be afforded a higher degree of moral responsibility. By pushing the topic of ownership and banking, your message may actually become more inviting of regulation and political attention that you intend. Our actions are in compliance with ASRM and you are the one insisting on labels of banks and ownership. Do you not think that there are people that will be happy to call your stores of patient-owned embryos a bank? This would give more fuel to the “personhood” advocates than my program that utilizes all of the viable embryos – as opposed to freezing indefinitely or discarding them.
You also imply that a bank that owns embryos is free to make any decision they want. We are following the guidelines that embryos are afforded a higher ethical standard and the only option for any embryos not transferred in a fresh cycle is to be transferred to another recipient couple. Is it necessary to label the embryos with an owner if we afford then the same ethical custodianship we would with any other embryo?
If embryos are to be treated with more than just a higher ethical standard, should we reduce them to property that is owned with a title or license issued to the parents? That is the slippery slope of your argument. Ideally we would all want to avoid such a thing.
Clinics everywhere encounter extra embryos as part of the pursuit of helping couples have children. The fertility community has deemed it morally acceptable to freeze hundreds of thousands of embryos that remain in storage year after year. This is considered ethical because someone “owns” them and can decide what to do with them. The most common option is to discard them. In our program, any embryo suitable for transfer is transferred. If there is an excess of frozen embryos, donors are not scheduled for a fresh cycle until there is a need for a fresh donor cycle. The program isn’t discarding embryos, yet you would find this somehow less ethical because someone doesn’t “own” the embryos.
I would suggest you focus less on your labels and more on the actual ethics of the actions. Less on the potential abuses and more on the facts of what is being done. Does the state own orphans? Do parents own their children? I think the thought of that would offend most parents. We have a responsibility and an obligation to them. So if we must own an embryo, do we give up ownership at implantation? My point here is the label of ownership itself invites regulation, while transferring all available embryos to fully informed recipients demonstrates compliance with an ethical obligation to the embryos consistent with a custodianship rather than ownership.
Just to be clear, fertility clinics have an ethical responsibility to treat embryos with a high regard for the potential people they represent. We are doing this without a doubt, and all of our viable blastocysts are transferred.
Your promotion of the term “embryo creation” is not advised as the term is borderline offensive. I would imagine most REI’s would feel that we are humble in our profession and actually are simply arranging the meeting of the sperm and egg followed by the meeting of the embryo and the uterus. Creation implies something entirely beyond our scientific understanding. Since donor sperm and donor eggs are being used, “donor embryos” is an acceptable term to distinguish the embryos from traditional “donated embryos”. Keep in mind that California Conceptions also has, and receives, donated embryos similar to your program. I agree our website is in need of updating as it’s not had any significant changes since the program was first introduced.
In regards to your statement “If all the cryopreserved donor/donor-conceived embryos find a home, I have less to complain about. What happens, however, if some of the cryopreserved embryos are never chosen? Who will decide their fate? Who should decide their fate?” I think you have less to worry about. You should have a very clear idea of the shortage of embryos available for traditional embryo donation, let alone embryos with a high potential for pregnancy. There aren’t embryos that do not get transferred in our program. Can you think of a scenario in which gametes from an egg donor and a sperm donor would produce a blastocyst that is not desirable? We are even transferring day 5 morulae with excellent results.
There are several very good points that most practitioners would agree upon. These will be the topics of ASRM’s discussion, and it’s not accurate to attempt to portray the upcoming meeting as some form of investigation of California Conceptions. I’m happy to discuss my program with ASRM and they are aware of this. As members, you and I will likely have an opportunity to comment on their opinion and suggest changes before it is published. I would imagine any published opinion would be in the form of a revision of the 2009 opinion on embryo donation – assuming of course they feel the need to publish an updated opinion. Getting into topics of ownership and treating embryos different from gametes could risk the types of attention none of us want. I’m confident what you want is ethical agreement and not government regulation of reproductive property, but some of your arguments are headed in that direction.
I do appreciate that this blog was much more thought through than the previous blog. Hopefully some of the commenters here can review my previous responses and refrain from making false assumptions about what we are doing. Even with news stories about IVF, there are plenty of people posting very strong opinions and disagree with any form of assisted reproduction. It’s not surprising that there are differing opinions about donor embryos and donated embryos. It’s good to voice these opinions, but care should be given to not wrongly accuse a program of doing something they are not doing.
Ernest Zeringue MD
California IVF Fertility Center
California Conceptions Donor Embryo Program
Dr. Zeringue:
I know you are aware that I did ask many people in the ART world to comment on my most recent blog. I also asked them to agree or disagree and I have not blocked any comments made thus far,including your own. I actually rarely block comments unless they are unrelated or inappropriate as I feel open discourse is so necessary to the quality of this blog.
I would agree that the physicians and embryologists have been relatively silent on the topic with respect to leaving comments. I suspect that they do not like to get embroiled in controversy much less disagreements that may occur between practices. Both myself and my embryologist have heard from a number privately but not here on the blog.
“My circle of internet friends” are my peers who do not hesitate to tell me when I am off base. Their opinions are their own and I could never force them into a perspective as they are far too independent in thought and personality for that.
It would appear that you are now stating that donor sperm + donor eggs = “donor embryos” and that this should be distinguished from “donated embryos.” That is an interesting point, indeed. I would have to defer to others regarding this distinction. I can’t think of another set of ART words that are so similar to each other that mean two totally different things. At the very least, I would be concerned that the general public will be unaware of the differences but perhaps they could be educated.
In reality, this is not the first time that this type of wordplay has taken place. The first “embryo donation” procedure that is often quoted (A Trouson et al. Pregnancy established in an infertile patient after transfer of a donated embryo fertilized in vitro BMJ 1983;286:835-8.) was actually a shared cycle with the first couple going through ART gave a fresh embryo to a 42 y.o. woman that happened to have an LH surge on the appropriate time. A trisomy 9 was the final result. I don’t think we really know when the first true “embryo donation” procedure actually took place, as defined by ASRM and contemporary literature. By your definition of “donor embryos,” I suspect the first case was probably in the middle 80’shortly after egg donation was first successful. I am unaware if your definition “donor embryos” is being commonly or currently used in literature or ART facilities.
As I have written, there is no angst between us. I’m not sure we have ever met although I did try to reach out to you, but never had a return phone call, after the first blog. I have stated that I feel your intent has been honorable and your goals patient-centered. You are offering a unique option that is more affordable than many others. My primary concern is the creation of an embryo bank, small or large, who owns the embryos and the unintended consequences that may follow. The ASRM Ethics Committee will hopefully take the topic up and I am certain they will look well beyond your practice in making their decisions.
If not actively resisted, the creation of embryo banks by other programs will certainly occur, except in New York where it is banned, as the financial incentive is simply too great for practices to resist. Your business model may morph into something less acceptable to both of us and the only option that I see to slow the movement towards the creation of embryo banks is for the Ethics Committee to make a clear and concise determination regarding the issues I have brought up and perhaps others that they feel I have missed. Once done, this will hopefully be enough to slow or stop the momentum towards embryo banks or the next probable outcome will be legislative events, for which we will all have minimal control.
The real difference between the California Conceptions program and traditional IVF treatments is that with California Conceptions ALL viable embryos are implanted and given the chance to become a baby either immediately or within a very short period of time (usually less than 60 days), whereas in traditional IVF programs a select few are implanted and the remaining are either frozen indefinitely, destroyed, or donated to science. So my question to you is: What embryo would you rather be? The one “owned” by a clinic but destined to have a chance to become a baby or the one “owned” by a patient but destined to be forever frozen?
“I suggest that any remaining embryos be owned by one or more of the recipients and the entire cycle should not move forward until at least one patient agrees to take the extra cryopreserved embryos, should any exist.”
So what you are essentially suggesting is to turn CC into a traditional program where most embryos are frozen indefinitely and have no chance at life. I find that very sad.
I am curious where you get your information regarding how long it takes for any residual cryopreserved embryos to find a home. You state that all are transferred within 60 days. What will happen if the embryo combination is not desired? What happens when this process continues to be done on an even larger scale? What happens when other practices perform the same process creating embryos in mass awaiting a home?
You may an excellent point that the embryos should have a chance at life. I agree this is true for all cryopreserved embryos. If half of the cryopreserved embryos are not use for reproduction by the individuals who created them, we have a great deal of work to do for the remaining frozen embryos to be used for good. Potentially increasing the number of embryos cryopreserved does nothing to rid us of this problem but only potentially complicates the issues.
The fundamental questions is who should own embryos. If practices are able to create embryo banks, then that is precisely what will be done. The financial advantages are simply too tempting. If this is done at other locations, it is only a matter of time before a facility will go out of business or that has a host of embryos are found languishing in cryopreservation.
At the risk of repeating myself, a physician or facility should not own embryos, no matter how good their heart is. If thousands of embryos are owned by IVF facilities and recipients are not found, what do you expect those pro-life individuals to do with that issue? I feel there could be a political backlash that could influence reproductive care for so many.
I would not assume that the embryos will find a home if owned by a facility. One does not make the other certain.
Thank you again for your comments.
[…] Unlike the IVF client who decides what to do with the embryos created from their own gametes, this clinic decides what to do with the “product” it creates. This is making many people uncomfortable. One doctor who works in the field considers it tantamount to being a “McEmbryo.” […]