Why Creating “McEmbryos” is Just Plain Wrong

Introduction

Recently, Alan Zarembo of the L.A. Times released a story alleging that California Conceptions was combining donated eggs with donated sperm and called them “donated embryos.” If there were leftover cryopreserved embryos, ownership of the embryos apparently went to California Cryobank (CC). If true, this is an egregious assault on reproductive ethics.

Defining embryo donation


About one-third of all patients undergoing in vitro fertilization (IVF) will have excess embryos to cryopreserve. About one-half of these will not be used for reproduction by the patients who created them. (Bangsboll et al., 2004; Lyerly et al., 2010) Embryo donation occurs when patients with unused cryopreserved embryos make the amazing decision to pay it forward and donate their embryos to patients in need. In true embryo donation, the patients own the embryos and make disposition decisions regarding their embryos. It is estimated that 2-10% of all cryopreserved embryos are donated to patients in need.

Why is creating “McEmbryos” so wrong?

Allegedly, California Conceptions would use donor sperm and donor eggs to create embryos. At times, all the resulting embryos would be transferred simultaneously to numerous couples, each receiving approximately two embryos at a time. This would commonly be called a “split donor/donor cycle.” It is, however, an absolute misrepresentation to call them donated embryos. At least in this split donor/donor cycle scenario, where all the embryos were transferred, there would be no cryopreserved embryos left whose ownership was uncertain.

What if not all the embryos were transferred and some were cryopreserved? As I understand, CC transferred no more than two embryos at a time to numerous patients, with the remainder cryopreserved. The residual cryopreserved embryos became the property of CC.

According to the article, egg and sperm donor profiles are sent to prospective recipients. As soon as CC received a “buy-in” from a few patients, the “donor embryos” were created from the donor eggs and sperm. Who made the decision to combine these two donors? What happens to the left over cryopreserved embryos? The article stated that dozens of embryos would be created through the combination of a pair of donors with the embryos then frozen while CC looked for patients who wanted them. And yet, the clinic claimed to have only ten sets of cryopreserved “donated embryos” in their tanks at any given time.

While they stated they didn’t want to create a bank, it would appear that this is precisely what was being done.

I feel there is a potential conflict of interest on the part of any IVF facility regarding the disposition decision of any cryopreserved embryos that they own. Patients normally have options such as using them to build their family, donation to science, donation to a laboratory for quality assurance testing and personnel training, keeping them cryopreserved forever, and finally, donating them to patients in need (embryo donation).

With the methods described in the article, a number of logistical and ethical questions arise:

  1. Were the sperm and egg donors fully aware of what was to be done with the resulting embryos?
  2. How did the IVF practice decide which sperm and egg donors should be combined? Was this decision made through market research? If so, who made these decisions?
  3. Is anyone tracking where all these donor-donor conceived offspring end up?
  4. Who ultimately owns the cryopreserved embryos? In the article, the physician interviewed said the clinic owned them when they were frozen
  5. Who makes the disposition decisions regarding these embryos? Will the IVF facility that owns the embryos be likely to make disposition decisions that do not benefit their bottom line? Who has the best interests of the cryopreserved embryos at heart when the embryos are owned by the IVF facility? Is it possible that CC is the entity that is really “donating” their remaining cryopreserved embryos
  6. What happens to the cryopreserved embryos if the practice closes or is sold?
  7. Perhaps most important, although it may not be a problem presently but for the future, what happens to the cryopreserved embryos that are never chosen?

While certainly not meaning to demean the cryopreserved embryos, I can’t help but think of these dono/donor cryopreserved embryos as fast food embryos or “McEmbryos.” I can just see the patients coming in, looking above the cash register to the menu above and ordering a “Number 3,” which has a burger (i.e., bright, blonde-haired, blue-eyed egg donor) and fries (i.e., handsome, athletic and tall sperm donor) and ends up getting the order supersized to boot (i.e., requesting twins). I should write clearly that this is not the current method CC uses to to match recipients to remaining cryopreserved embryos but the slippery slope exists and other practices may eventually emulate this process

What did EDI try to do over the past year to remedy the problem?

We suspected what might be happening at CC well over a year ago but didn’t have proof. We approached the American Society for Reproductive Medicine (ASRM) who examined the information and eventually sent it on to the Society for Assisted Reproductive Technologies (SART). SART did an investigation agreeing with our preliminary assessment. Unfortunately, CC was not a member of SART so they had little influence with CC.

There was some discussion of placing CC on the Center for Disease and Control’s (CDC) radar, asking that they potentially audit CC. I am not aware if this was ever done.

There was some discussion of revising the Ethic’s Committee Opinion on embryo donation detailing the inappropriateness of creating “McEmbryos,” but in the recent revision sent out to all ASRM members to review this past August contained no such language. I contacted ASRM and volunteered to help write the couple of paragraphs that would address the issue but I was never contacted. My current understanding is that the ASRM Ethics Committee will be taking up this issue in the beginning of 2013 and I am hopeful they will make a stand against creating “McEmbryos.”

Is it really ASRM or SART’s fault?

ASRM and SART are membership organizations. Anyone can join ASRM whereas SART is only open to IVF practices. These entities are not designed to truly police their members. Certainly, they can bar them from membership, but let’s face it, this is really not much of a punishment. Most patients are not really aware if a practice is a member of either organization, so expulsion does more to protect ASRM and SART from criticism than it does to protect the patients.

In reality, I am not suggesting that ASRM or SART begin sanctioning their members. These organizations are made up of bright individuals wanting what is best for members and patients alike. I don’t believe ASRM or SART could ever expose themselves to legal liability and try to be anything more than what they were originally designed to be.

I feel criticism towards ASRM and/or SART is potentially misplaced. While I do feel these organizations can certainly take a stand against the creation of “McEmbryos,” they can only provide educational materials and information to members and patients. never entering the realm of fining, condemning practices or policing practices. That is simply not their job.

I am not being insensitive to the needs of the patients

California Conceptions is providing amazingly healthy embryos to patients in need. How could anyone not be touched the story twin girls born to a single 41 year-old woman? There is no question that the donor/donor split cycle can be far more cost effective than many other options. The ends to this process are what we all strive for – a healthy family.

Call me old-fashioned but I still feel there are instances where the ends cannot justify the means. Are we are loosing all respect for the embryos and treating them utterly as a commodity? The slippery slope is becoming quite steep. Are we ready for expanding banks of unclaimed embryos across the country owned by practices or physicians and not the patients? I’m sorry but the means being used here are fraught with uncertainty and may result in a list of unintended consequences.

What are the potential repercussions of the L.A. Times story?


At least this election year is over. I had grave concerns that the story would break early in the election cycle and would become a political football, resulting in a series of consequences around the country. I still believe we are at risk in the following ways:

  • • Poorly designed and reactive legislation may yet be created on state or national level
  • • This story may motivate the “Personhood” advocates by encouraging them to win personhood for embryos thereby protect them from becoming “McEmbryos”
  • • There will be “guilt by association,” leaving other legitimate embryo donation facilities open to criticism and ridicule
  • • All of this will reflect poorly on basic IVF facilities that are frequently viewed as unregulated, even though we are accountable to more regulatory agencies than any other area of medicine

There may be significant backlash regarding this story and we should all be prepared to answer questions that may arise from the media, our peers and our patients.

How can embryo donation programs hold but not own the donated embryos?

At Embryo Donation International (EDI), the embryo donors are still able to request that their donated embryos be returned if needed. For example, if the children of an embryo donor were tragically killed in a motor vehicle accident, it seems absolutely appropriate that the cryopreserved donated embryos should be sent back to the donors. To discourage this from being done without good reason, transportation costs for returning the embryos, which is estimated to be $300, are the responsibility of the original donors.

Once the embryos are transferred into the recipients, however, they now “own” them. In this way, EDI never truly owns the donated embryos. We are the conservator and protect the embryos while never making any disposition decisions regarding their fate. We never own the donated embryos and we encourage all embryo donation facilities adopt this model of conservatorship.

What can be done to correct the current problem?

    From my perspective, we have a few options:

  1. Various membership organizations such as ARSM, Pacific Coast Fertility Society (PCFS), SART and RESOLVE could release position statements condemning the creation of “donated embryos” without a destination. This could help guide public opinion.
  2. Perhaps the embryo donation programs would be willing to sign a contract stating that they will not participate in the creation of embryos without a destination. Programs willing to sign and honor the contract would be adhering to the highest of ethical standards.
  3. Through the court of public opinion and if the L.A. Times article is accurate, patients may no longer want to participate in what they feel in an unethical practice.
  4. Legislative action on the part of California may be necessary but this will take time and a great deal of expertise. We run the risk, however, of having well-meaning legislative actions spilling over and harming the process of embryo donation or IVF itself.
  5. CC itself may need to modify its business model by allowing patients to own the cryopreserved embryos.

Something really needs to be done. I don’t feel that this unethical practice should continue. A corporation, business or physician practice should never own embryos, no matter how brief. These embryos are also not truly donated unless you feel CC is able to donate the excess cryopreserved embryos. The question is if we should play an active or a passive roll in determining what takes place. I personally prefer the active roll so you can count EDI in on doing our best to guide the process.

Sour grapes? Nope, just sour taste!

CC is a potential competitor of EDI. I have made this clear to each and every person I have spoken to regarding this current dilemma. When we were contemplating the expansion of our ten-year embryo donation program into EDI, we also looked at the option of a money-back guarantee such as is offered by CC. Understanding the delivery rates for recipients of truly donated embryos ranges from 27-45%, the likelihood of returning the majority of the payments back to recipients made it unlikely we could even keep our doors open. Most “shared risk” options also charge a premium on top of the normal fees. Recalling that embryo recipients are emotionally and financially drained, the idea of tacking on a large additional fee seemed unfair to the recipients and quite impractical to the process. Embryo donation works for recipients, in part, because it is more cost-effective than many other options.

So you see, it is not “sour grapes” that is guiding my writing; it is just a sour taste. If the article was accurate, I feel strongly that creating “McEmbryos” is an affront to IVF and embryo donation programs, misleading to embryo recipients and totally unfair to the cryopreserved embryos that are currently waiting to be chosen.

If you agree, please co-sign this blog….

We are going to do something a bit different with this blog. We are strongly encouraging not just the routine comments that follow our blog but we are also asking that practices, patients and interested parties who agree that creating “McEmbryos” is ethically inappropriate sign below. By endorsing the statement below, we will hopefully begin to separate ourselves from such entities that practice the “McEmbryo” method of “embryo donation,” moving forward with a resolution that will work best for all.

By signing below, I do hereby agree that creating banks of cryopreserved embryos is ethically unjustifiable and support sound solutions that will adhere to the highest of ethical standards supporting patients and cryopreserved embryos in the best possible way.

28 Responses to “Why Creating “McEmbryos” is Just Plain Wrong”

  • Elizabeth Price:

    While I agree with you that using the term “embryo donation” for what is really a dual-donor shared cycle is misleading, I disagree that what CC is doing is inherently unethical. It is a slippery slope, yes, because there is potential for abuse in the system. CC offers hope to couples who are not eligible for what we normally think of as embryo donation. Face it, competition and waiting lists are scarce and many programs including yours are forced to discriminate, er, prioritize just because demand outpaces supply. Couples who need two donors but who cannot afford a traditional egg donor program have an opportunity with CC that they may not have anywhere else. I have a pair of friends who are pursuing conception through CC’s program now, and if this door also becomes closed to them they will be completely out of luck.

    Unless you have reason to believe that CC is actually engaging in the potential unethical practices you mentioned – for example, dishonesty toward the donors or creating a bank of embryos that may never be selected by a recipient couple, I would ask that you not take away the one glimmer of hope some infertile couples have to grow their families. It may be reasonable to ask them to stop using the term “embryo donation” to describe their program, as use of that term is extremely confusing. But please don’t try to shut them down without very very good reason.

    I myself have contacted CC as a potential client. We chose to go another route, as we had another option open up for us (I’m on your waiting list but I’ve been more or less assured I’ll never reach the top). I can assure you that the person I talked to at CC was up front about explaining their process to me and although their website is pretty vague I understood after talking to him that their program was a double-donor shared cycle. Even though we chose not to participate with CC’s program, I was the one who recommended it to my friend after she was turned down for an embryo donation program.

    Please feel free to contact me if you would like to know more about my experience. I think my friend would also be willing to speak with you about her experience so far with them.

  • anonymous:

    I’m choosing not to sign or leave my name, but I do agree with the above blog. My husband and I came very close to using CA conceptions to adopt embryos. We had the consult with Dr. Z, who was quite honest about what their process was. He explained that he would review our request, find 3 or 4 other couples who were looking for embryos with similar characteristics, then create a batch of embryos, splitting the batch among said couples for $9800 plus expenses. I kept asking Corey (the IVF coordinator) prior to my consult, who the original parents were. I could never get an answer from him. Dr Z. didn’t come right out and say it, but clearly there are NO original parents. I was able to persuade Dr. Z to send me a list of his egg donors, and that decided it for us. They had poor histories. Several had sexually transmitted diseases, a few had alcohol and drug issues, and I could not find a single donor without at least 6 or 7 piercings and/or tattoos. We opted for another, honest route, and I’m SO glad we did.

  • Dr. Sweet, the LA Times article is correct, though your perception of it is off on several accounts. I’d be happy to discuss this with you professionally, as you feel very compelled to bring this program to justice. Your points that embryos don’t have a destination, are sent to California Cryobank, and are somehow “designer babies” like a fast food order is entertaining, but far from accurate. Any embryos not being transferred are matched very quickly and really are no different than the embryos you are “holding”. Your own website has a call for people to donate their embryos to EDI. Does EDI own them without a destination? You could apply all of your same ethical questions from the moment the donating couple “donates” the embryos to you. Your only difference is a “take back” clause whereas we are matching the embryos with little to no delay.

    All of your above questions are easy to answer and if you approach this fairly, I’m certain you’d be satisfied. Our recipients and donors are fully aware of the program and details. I am an ASRM member and would gladly answer their questions as well. We have been inspected by the FDA and the program was explained to them with no concerns raised. We had no deficiencies in our inspection and were commended on or organization. I have discussed the program with doctors from many respected IVF programs and most of them refer patients to us.

    I would hope that out of the interest of fairness, you post my reply on your blog. I agree with your concerns that you have raised and would be happy to discuss your questions so you may be reassured California Conceptions is not “McEmbryos”.

    Ernest Zeringue MD
    California IVF Fertility Center
    530-771-0177

    • Dr. Zeringue:

      I do so appreciate your taking the time to respond to the blog. I would like to answer the questions that you pose.

      First, I don’t use the phrase “designer babies” anywhere in the blog and I am not partial to the term as I suspect neither are you.

      Second, we do not own any embryos that are sent to EDI. As I explain in the blog and the website, the patients who donated them own them. They can pull them back at any moment should it become necessary, although they will be responsible for the transportation fees and perhaps some other fees we spent bringing the embryos to EDI. We hold the embryos but are never are able to make disposition decisions about them. The patients clearly own them. When presenting this model to the Family Law section of the American Bar Association, they felt this was an excellent model suggesting that other programs adopt it. I will tell you that we have only had to send back two sets of embryos in eleven years, so the chances for pull-back are remote. I do strongly feel that IVF programs such as ours should never own embryos.

      Third, we do not match embryos to patients. The donors set stipulations and the recipients have to match them. If they match the conditional donation stipulations, then it is up to the recipients to accept the donated embryos or not. The donors set the stage and the recipients have to fit that stage and feel comfortable with the embryos themselves.

      While California Conceptions has perhaps been diligent in trying to minimize the number of embryos in “the bank,” I would really be interested if there are only 10 or fewer sets in cryostorage at any given moment. Perhaps you can provide actual data to alleviate our concerns. I will also tell yours is not the only program that is creating embryos for future use. I am aware that this is quietly happening in other areas of the country in other programs and it will inevitably get out of hand if it is allowed.

      You are providing an amazing service. Your prices are very helpful for some patients compared to other options. Your business model might only have to be changed slightly to make it such that your practice doesn’t own the embryos at any point in time. While perhaps your “inventory” is rapidly transferred, I guarantee that if this model is adopted by other programs, we will end up with banks of unused embryos.

      While I cringe at the idea of comparing cryopreserved embryos to live children, the metaphor is useful to prove a point. We would never ask people to conceive children purposefully placing them in a foster home for adoption. In such a world, there would inevitably be some children that would never be chosen. Such a system would treat the children as commodities to be created and sold. This is a type of world I would not want to be a part of.

      If we feel the embryos are only cells given the same level of respect as sperm which we toss into the biohazardous waste container when done, then I do not have a leg to stand on. At the same time, I do not want to see embryos given the same level of legal respect as our patients (i.e., personhood), as I describe in my metaphor above, as this would change the face of infertility care across the country. Instead, the embryos deserve an intermediate level of respect but respect, nevertheless. Having them in a bank for any duration owned by the IVF program is not a road to be traveled without consequence.

      I welcome your request for open discussion between our programs as we probably have much in common. Please also understand, however, that there are many others in our field that have significant concerns about how your program is set up and the fact that it owns the cryopreserved embryos at any point in time. Some of these individuals are even far more vocal than I have been.

      After the holidays, let’s try to talk and see what we come up with. I promise to write a second blog if there is anything to retract or further support. My concern is absolutely not personally with you or your staff as I have the utmost respect for practitioners in the field who have dedicated their lives, like mine, to building families. It is only the means that I am concerned about and that needs to be discussed in tremendous detail at many levels by many different people.

      Craig R. Sweet, M.D.
      Embryo Donation International

  • Thank you Dr. Sweet for exposing this unethical practice.

  • Thank you for posting my comments and responding. While you did not use the term “designer babies”, it was fully implied by your paragraph about ordering a “Number 3″. The blog did not discuss other programs, it direcectly implicated my program of unethical practices. We don’t know eachother personally so I’m not taking it that way at all. I think it’s important to not have the program accused of things that simply aren’t true.

    Beacuse there are always possible “slippery slopes”, this should not preclude ethical fertility practices from helping patients. With the proliferation of IVF itself, many people proclaimed it wrong because of potential ethical abuse. The field will continue to evolve and we should continue navigating our way to providing patients with options for preganancy. We agree on this point so it comes down to how we go about doing this.

    Our programs are different and can not be directly compared on all levels. My program is not by default wrong because it doesn’t follow your model of handling embryos. The mear designation of “ownership” to a large extent is irrelevant. What are we doing with left over embryos? Matching them to another couple. Are we deciding thier disposition? Yes, we are matching them to another couple. Are there scenarios of ethical abuse? No, saving freezing them after a fresh cycle and matching them to another couple (usually before the cycle starts or within a week) is not the same as an embryo warehouse or cryo bank in the sense of sperm or egg banks. The disposition of embryos is pre-determined as part of the program and we are not deciding anything other than matching. Embryos are treated as “potential people” and the opportunity for a couple to have a child. We both value this potential obviously. There is no alternative for the embryos other than transfer and no benefit to anyone to treat them otherwise. Establishing “ownership” really has no part in this process. We don’t “own” our children thoug we are responsible for them. Embryos aren’t given status as a person, so does that by default mean we have to “own” them? Does “owning” them mean we can do as we please? If you really dig into this arguement you can quickly see how it can become irrelevant. A transient period from cryopreservation to a subsequent match does not constitute a “bank”. We both agree that a bank of embryos like a sperm bank or egg bank is not what we are after. Yes there is a slippery slope and others may go down an undesired path, but until we do, we have not created a true bank. We may not agree on this but that by defualt does not make us wrong or unethical. Are there examples where we have done anything that is unethical with the embryos?

    The comment about 10 sets embryos in cryopreservation referred to 10 sets that were cryopreserved and not already mached. It’s uncommon there are even that many because of the logistics of how we match – I had to come up with a number during the interview and estimated 10 sets. Matching is very fluid and dynamic so the number changes as people make selections and new donors go through the program. There may be times that we have embryos frozen that have been accepted and are scheduled for transfer, but in my mind these now “belong” to the recipient. Outside of sending you our inventory logs, there is no real way to prove this. I stand by my original statement as it pertains to unmatched sets.

    Recipients are free to select profiles or pass and wait for additional matches – similar to other programs with donated embryos. We are not forcing them to select anything and are not making decisions for the recipeint. The donors’ profiles are available to the recipients as you can tell by the post above. Again, this may not match your program, but I don’t believe any one program establishes the standard.

    Feel free to email or call. If I’m tracking things right, it seems your only real concern with California Conceptions at this point is the “banking” phase. We may not agree on the terms banking and ownership as it applies to California Conceptions, but I think we both agree that we don’t want to see embryos banked in a similar manner as eggs and sperm with large catalogs and a supply that exceeds the demand (yes, I cringe at these terms too).

    Ernest Zeringue MD
    California IVF Fertility Center

    • Dr. Zeringue:

      Thank you once again in taking the time to explain your position and the process practiced at California Conceptions.

      We are probably going to have to agree to disagree on regarding the positon that corporations, business or sole practitioners should not “own” cryopreserved embryos (capable of making disposition decisions), even if it is for the short period of time that you have tried to create in your practice. At some point in time, if it hasn’t happened, embryos will be waiting to be transferred without their “parents” able to make disposition decisions. This ultimate acceptance of your methods and reasoning will need to be decided upon by our peers and our guiding societies.

      My other concern, which pales in comparison to the issues of embryo ownership, involves your use of the term “embryo donation” to describe the service you provide. What you are doing is an egg donor/sperm donor combination and splitting the embryos among recipients. In fact, the only entity that is truly donating the embryos is your practice.

      Words are important. Using the “embryo donation” phrase to describe what you do, at some level, inadvertently demeans the amazing gift that true embryo donors provide in “paying it forward” by donating their cryopreserved embryos to patients in need. While certainly not an attorney, I have heard the argument made that CC is, at the least, falsely advertising their services. To answer that concern, the definition of embryo donation must be clarified and the ownership of the embryos clearly delineated. I hesitated to make this a truly important point in the discussion for fear that some would feel that my argument was self-serving perceiving competition by CC. EDI has dedicated itself to decreasing the number of cryopreserved embryos discarded or abandoned while increasing the number of embryos donated. Your practice creates donor/donor embryos and splits them between patients without making any attempt to decrease the number of cryopreserved embryos discarded or abandoned. We seem to have very different philosophies and word definitions when it comes to this issue and the words we use.

      I am pleased that we both strongly agree that an cryopreserved embryo bank is not desired by either of us. As I hoped, we have some goals in common. Still, my concerns are not invalid as it is inevitable that your recipients will, at least temporarily or perhaps for longer, be unable to receive your embryos (i.e., illness, transportation issues, financial constraints and so on) and that they will remain cryopreserved in your practice, owned by our practice and waiting to find a home. An embryo bank may have ten embryos in it or thousands. Certainly, we would both agree that it would be egregious to have thousands languishing in cryopreservation. The inevitable issue is that a bank of ten embryos is still concerning making this topic worthy of continued discourse. I am not an alarmist. I simply see a very slippery slope up ahead and a host of unintended consequences occurring, no matter what your original efforts may have been.

      Looking forward to our conversation soon.

      Craig R. Sweet, M.D.
      Embryo Donation International

      • KD:

        Dr. Sweet:

        As a former patient of Dr. Zeringue, I must speak up on behalf of the ethics of this man and his entire staff at Cal IVF and CC. I was a traditional patient undergoing IUI and IVF with their clinic from 2006 through 2008. Dr. Zeringue and his staff were nothing but professional, personal, compassionate and, above all…ethical. We had many discussions about this and I was always so impressed with Dr. Z’s approach and opinions on all the subjects. I was a patiendt during the whole “octomom” situation and Dr. Z was very outspoken on that topic as well. He and his staff counselled us extensively when it came to deciding on the ethical practice of how many embryos to place back.

        A year after the birth of our beautiful son, we wanted another child. But…we did not have insurance coverage, our savings account had not recovered quite yet (even though Cal IVF fees were extremely competitive and reasonable, we had still spent over $45k to achieve pregnancy with our son). We were older, our chances of being successful with our own egg/sperm were minimal at best (We had both ADA mom and male factor dad). We explored traditional adoption….Minimum $35-$30k and huge competition and some places would not even consider us due to age or already having children. We went through all the foster-adopt classes only to be told we would be at the bottom of the list because we already had a child, we were wanting to keep our son’s birth order and the state budget crisis had restricted funds for the proper level of Social Workers required to facilitate these adoptions. Overall…we were at a dead end. That is when we went back to Cal IVF. We went through the traditional embryo donation program. We were put on a waiting list and were lucky to be matched within 6 months. It was during these treatments that Dr. Z told me about the huge interest they were getting in their embryo donation program (which they still have ….but getting people to actually donate their embryos is very difficult….I know I would have had a hard time with it). He said he was trying to find a way to make it more affordable for people who needed donated eggs/sperm to build families. Even though I am a traditional embryo donation mom (my gorgeous daughter just turned two last week)…..This program is a god-send for soooo many couples who want to build or complete their families and have exhausted all other options. For those people who don’t agree with it….don’t do it. But I can assure you….the only intention Dr. Z and his staff have…is to help people build families. I KNOW this….we felt so loved while in their care…and even now…months/years later when I run into staff members or Dr. Z’s wife at the mall….they remember us….they ask about our FAMILY that they were so gracious to help us build. When we had a miscarriage their compassion for us was genuine and they shared tears with us.

        CC and Cal IVF’s goal is to build families. For you to refer to them as “McEmbryos” is insulting to those of us (and the whole Cal IVF, CC staff) who know them and have walked this journey with them. My family is complete, but if it weren’t ….. you bet I would be going through this program. I tell everyone I know who is struggling with fertility and has run out of options about this….because ultimately…we all want our family right? These babies are WANTED. They are created WITH intended parents and very few embryos remain in a cycle ever. I know you have your opinion on the “Bank” aspect….and you are entitled to that…but to belittle the intent of the program by referring to donor profiles as “A Number 3″ sounds a little bit more like jealousy or fear of competition than it does like a professional in the same business truley worried about ethics. Yes…there are thousands of frozen embryos out there that I would love to see have the chance at life….and I commend you and YOUR progam for trying to facilitate that….But please….don’t be so quick to pass judgement on a colleague before truley understanding the intent and logistics of the actual program.

        You are very revered in the IF community…I see you post on BBC threads and Embryo Adoption/Donor forums often. I always enjoyed reading your approach as a professional in the business….until this blog post. It is okay to have questions…and it is okay to have a differing opinion….but you are right…the words you choose (Donor Embryos vs Double-Donor Cycles) is very important to those who may not have as much experience….just like “McEmbryo and A Number 3″ could derive a different feeling from the uninformed reader than maybe “Creating Embryos using double donors, or reviewing profile options” could.

        Regards,
        KD

        • I have a tremendous amount of respect for practices that have dedicated themselves to building families. How this is done is as important as doing it.

          I do believe that California Conceptions (CC) did not want to create an embryo bank. Nevertheless, as they stated in the recent L.A. Times article, they probably had 10 sets of embryos cryopreserved in storage at any given time. Originally, a group of embryo recipients agreed to use the combination of an egg donor with a sperm donor creating numerous embryos. Each recipient received one to two embryos with any excess embryos cryopreserved. I believe that CC would prefer that none would be left over but it is inevitable that some would be frozen for future use. Jeralyn commented on this blog indicating that she did indeed conceive using cryopreserved embryos at CC from a different batch (i.e., embryo bank). While I applaud California Conceptions for trying to minimize the size of their embryo bank, I truly feel it should not exist.

          From my perspective, I have a number of concerns:

          1) These are not really donated embryos but embryos created from a donor/donor cycle split among patients. Facilities that practice this should call it “Embryo Creation” or some such phrase and not “Embryo Donation.”
          2) I feel strongly that a corporation, business entity or physician practice should not own embryos. Embryos should be owned by the patients who created them.
          3) The creation of embryo banks could have a host of unintended consequences. Besides reducing the respect to the embryo to that of simple cells that are discarded after use, you can be certain that legislative actions may be initiated to try to protect the cryopreserved embryos potentially making it increasingly difficult for practices to care for the infertile patient.
          4) If a small embryo bank is allowed to exist, you can be certain larger embryo banks will form and my prediction of the creation of a “McEmbryo” will unfortunately come true.

          As stated previously, I meant absolutely no disrespect to you or your unborn child. The phrase “McEmbryo” was used to make a point – an important point. If a small embryo bank is allowed to exist then a larger embryo bank will certainly follow wherein the prediction of the creation of a “McEmbryo” will truly come to be.

          You received an amazing gift from a patient and I am so pleased that you were successful. Embryo donation is a wonderful gift. Be encouraging embryo donation, we continue to try to reduce the number of embryos discarded or abandoned. We are not, however, encouraging the number of embryos cryopreserved purposefully increase to increase the number donated.

          There are remedies for California Conceptions that will bring it in line with accepted medical practices. All the excess embryos must be owned by the patients. In addition, so as to not mislead the potential patient, calling the practice of donor/donor split cycles something other than “embryo donation” would seem to be appropriate.

          Please, I did not do this because of competition concerns. I did this because I believe that this is the wrong direction to take for a host of reasons listed above. It won’t be hard for CC to change gears a bit, provide a cost effective option for patients, build families and yet not create an embryo bank. We should all encourage them to voluntarily move in this direction before legislative action is initiated with its inevitable string of unintended consequences.

  • [...] 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, [...]

  • Thanks Dr. Sweet for posting this question. I agree that we need to consider all the ramifications of these evolving services. My personal experience with in-house embryo donation among patients in a fertility clinic makes me think that temporary custodial “ownership” if you will of embryos by clinics is probably a more common thing than you might think during the matching process. I see obvious advantages to patients from the CC approach–the ethics of any of this is determined by the details of how it is handled by each program. The real unanswered question for me is regarding the resulting children. Have we created systems that allow these donor -conceived children to have the option of finding their biological roots- either their siblings or possibly- if both parties agree–their biological donors? In our rush to satisfy the needs of our patients, are we paying too little attention to the effect of our services on their children? Or is that simply not our problem as providers? I don’t have the answers but I certainly welcome the discussion. I posted on the “embryo creation for donation” topic on my own blog. http://bit.ly/SmkZIV

    • Carole:

      Wonderful questions. I know how easy it is keep our focus on the infertile patient. That is what I have been doing for about 23 years. We do all that we can for those individuals and couples that are striving to create a family and fill a void that is otherwise so difficult to fill. We do it for our patients.

      Along comes the donor-conceived offspring. Perhaps they are told of their origins or worse, they somehow find out in an unexpected way. They are curious about their donor or donors in the case of embryo donation or what is done at CC. These offspring also have a void to fill, different from our, patients but a void nevertheless. These donor-conceived offspring were never our patients. They were never truly seen by us or touched by us and tend to be forgotten by us.

      So the case of egg/sperm/embryo donation, our major focus is again our patients. It is a “parent-centric” process. In the case of adoption, the needs of the child are given a much greater priority than the needs of the parents adopting a child. This is a “child-centric” process. These are two different perspectives often with competing goals. In the case of creating an embryo donor bank, no matter how small, we are again clearly focusing on potential parents and not the child or children.

      It is my goal to do the best we can to blend the needs of all involved. I’m afraid that is quite unlikely when egg donors are mixed with sperm donors and the embryos are passed among many. There are many changes that are needed in this donor/donor split process and I agree that we need to keep our bearings understanding that we are not just taking care of the potential parents, but that have a level of responsibility to the donor-conceived offspring, who have no voice in the current decisions. Still, I believe many of us hear their voices and are working hard to balance the parent-centric requests the child-centric desires blending them into a “family-centric” outcome.

      We have much work to do.

  • Georgette:

    I disagree that what CC does could be considered unethical. My main purpose in commenting, however, is not to attempt to add to their excellent defense…but simply to say there’s nothing wrong with requesting, if possible, an embryo who approximately matches the parents-to-be and their characteristics… my husband is Filipino and I am Caucasian, and to wait for a naturally donated embryo to match this racial mix would take forever. I find it much more troubling that their egg donors may be unhealthy individuals…but that’s an issue any recipient has to investigate for themselves, regardless of the program.

  • Sheila Riche:

    On this point, I agree with you Dr. Sweet. When I heard about the services that California Conceptions offers, I couldn’t help but cringe at the thought of embryos being created via complete strangers. That in and of itself is a slippery slope indeed. As I’m sure you’re aware, I’m more concerned for the pre-born humans that will have to deal with that reality in adolescence and adulthood. While a minority will not struggle at all with their creation, I have not doubt that quite a few will. Questions like: What are my origins? What are my roots? Why did my genetic parents choose to donate? Did they think about how this might affect me in the future? Do I have full genetic siblings in this world? Can I have access to my medical history? Who am I?

    It’s way too easy to create pre-born children that literally have no voice in the early years. Do we just shrug our shoulders and wash our hands of how this might affect them when they do form an opinion about those responsible for the way in which they were created? Do we have a responsibility to create ethical standards that will span the years, knowing the decisions we make now WILL affect a human being well into the future? Or should those children just keep their mouths shut and be grateful that they were created at all?

    Something to ponder.

  • HappyCCPatient:

    I have POF and my husband has sertoli cell only syndrome so in order for us to have a pregnancy and a child we would have to do a double donor cycle. This is exactly what I am doing at CC. I can also do that at Shady Grove, or my local fertility clinic but the difference is, I would be paying at least $20,000. Splitting the cycle makes it affordable. Why is there scrutiny on CC but not on other clinics that offer split egg donor cycles? Singling out CC seems like the work of those that feel CC has an unfair advantage. Because they’re offering a service at an affordable price they are being targeted.

    • I believe that what you are stating about Shady Grove is actually done in many clinics. Combining donor sperm with donor eggs and creating embryos that are yours is a common practice. By doing so, you have a fresh transfer and the excess cryopreserved embryos are owned by you to be used by you. Hopefully, after your successful delivery, you would go back to Shady Grove and ask that a frozen embryo transfer be performed so you could further build your family. If there are excess cryopreserved embryos after you have completed your family, you have to decide what to do with them including discarding them, donating them to science or hopefully, donating them to patients in need.

      Shady Grove doesn’t own the embryos, you do. Shady Grove doesn’t have an embryo bank. Shady Grove isn’t calling the donor/donor cycle embryo donation.

      There are ways that California Conceptions could slightly modify what they are doing so that they can provide you embryos in a cost affective way without owning the excess embryos. Lastly, in truth, the process should be called “Embryo Creation” and not embryo donation. Doing otherwise debases the amazing gift that embryo donors give when they donate their cryopreserved embryos to patients in need.

  • Jeralyn:

    Dr Sweet I agree with you that the utmost care should be taken to ensure that embryos are handled in an ethical manner but I fail to see how California Conceptions has handled the embryos in a way detrimental to those said embryos. As I understand it you have two issues with the California Conceptions business model, one, that they own the embryos and that ownership “could” be a slippery slope for some other businesses to create an unethical business practice and bank dozens and dozens of embryos. And two, that they are calling the embryos “donated embryos.”

    If California Conceptions has not been shown to have done anything unethical I think it’s completely unfair to call their practices unethical based on what other businesses might do in the future. They are not sliding down that slope and should not be held responsible for what other businesses might do in the future.

    As far as calling the embryos “donor embryos”, the embryos are created from donor egg and donor sperm and in my mind it is not wrong or unethical to call them donor embryos. I agree with you that your definition of donor embryos is different but that does not make California Conceptions wrong, just different. I would be interested to know what you think they should be called? I am a current patient of California Conceptions and am now five weeks pregnant through their program. I cannot say enough good things about my experience with CC. I was made very aware that the embryos were from a shared donor/donor cycle when I first contacted the clinic. As it turned out the embryos we were planning to transfer from a fresh cycle did not progress as hoped. We were provided with an alternative profile, previously frozen from a fresh cycle a short time earlier. I have no issue with my unborn child/children having at one time been called a donor embryo. I am however deeply offended by having my unborn child called a “McEmbryo.” We only asked CC to match us with embryos “similar to us.” We did NOT order out of a catalog a designer baby.

    I would also like to address the comments made earlier in this blog regarding the health of the donors. We were provided with extensive medical background information for both our prospective fresh cycle and the alternative frozen profile donors. None of the donors in those profiles had any medical issues in their histories, which as I said was extensive and included their family histories. I do not consider tattoos or piercings medical red flags but neither of the egg donors had “6 or 7″ and neither of them had had any sexually transmitted diseases. Also, like Dr Z stated we were given the profiles with the opportunity to approve or disapprove the match if there had been any issues.

    Lastly, I have given a great deal of thought to what we will tell our little one when they have questions and it will never be secret. Our child will always know how much they were wanted and loved. We believe the donors are to be appreciated for the gift they have given so we can have a child in our life that we so desperately wanted.

    • Jeralyn: Congratulations on your pregnancy and I hope all goes well. This clinic is not performing embryo donation, they are performing “embryo creation.” The definition of embryo donation is not just mine, it is an accepted definition by the American Society for Reproductive Medicine as well as other guiding medical societies throughout the world.

      With embryo donation, the goal is to decrease the number of embryos discarded or abandoned by encouraging patients to instead donate their embryos to patients in need. The goal is not to create more embryos and then call them donated embryos. If they are donated embryos, who is donating them? The clinic?

      You conceived through an embryo bank. It is clear that you chose embryos that were owned by the clinic and not donated by patients. This process of creating embryos has been tried before with the practices, to the best of my knowledge, discontinuing the process. (http://www.nytimes.com/1997/11/23/us/clinics-selling-embryos-made-for-adoption.html?pagewanted=all&src=pm)

      I meant absolutely no disrespect to you or your unborn child. The phrase “McEmbryo” was used to make a point – an important point. If a small embryo bank is allowed to exist then a larger embryo bank will certainly follow wherein the prediction of the creation of a “McEmbryo” will truly come to be.

      I am not at all sure what comment you are referring to regarding the health of the donors. I suspect you are not referencing my comments but feel free to provide a bit more information.

      I am pleased that you have decided to tell your child of their origin. I think secrets such as this are hard to keep. With that stated, what will be done when your child wants to know more about the donors? What happens when he or she wants to connect with their blood siblings? These questions are not at all unique to CC but need to be addressed by all of those programs offering such services.

  • KD:

    One more comment Dr. Sweet. There are many, many Fertility clinics around the U.S. which have donor embryo programs. Most of these are anonymous donations from previous patients. The embryos are donated to the clinic. The clinic does paperwork to transfer ownership of the embryos from the genetic (or original parents…sometimes these embryos were created using donor material) to the clinic. They are then “owned” by the clinic until a suitable match is made to a donor couple. This is usually a short time, but not always (sometimes the embryos are not of great quality and are rejected by recipients). Will you now be going after all of these clinics as well…stating they are unethical and creating embryo banks? When you take a stand on a subject like this publicly, keep in mind you may end up harming the practice in general. This is another reason I would caution you about posting public opinions on an “article” you read before contacting the subject (Dr. Z) directly and discussing it with him. It just seems like if you have a beef with someone….talk to that person before slinging around derogatory statments like “McEmbryos” and “A number 3″ regarding their practice. Other than a short window of time where minimal embryos are cryopreserved….Cal Conceptions has debunked all of your “concerns” about the creation of the embryos without intended parents…they are not shipped off to Cal Cyrobank for eternity and the recipients don’t provide a long list of designer details they want in their embryos. Most people just want a healthy baby with an ethnic/race similar to their own. When I went through the traditional program….we had ZERO requests on race/color/creed…we just wanted a healthy baby. I know several couples who have gone through donor cycles (personally, through blogs and on forums)…the vast majority have very few requirements other than good health and a close ethnic match. Of those who do make extensive lists…they wait longer or end up not doing it because most programs won’t cater to those minute details.
    Just more food for thought here.

    Regards,
    KD

    • Actually, you bring up an excellent point. I believe there is a far better way for true embryo donation programs to operate rather than “owning” donated embryos. As I stated in my original blog:

      “At Embryo Donation International (EDI), the embryo donors are still able to request that their donated embryos be returned if needed. For example, if the children of an embryo donor were tragically killed in a motor vehicle accident, it seems absolutely appropriate that the cryopreserved donated embryos should be sent back to the donors. To discourage this from being done without good reason, transportation costs for returning the embryos, which is estimated to be $300, are the responsibility of the original donors.

      Once the embryos are transferred into the recipients, however, they now “own” them. In this way, EDI never truly owns the donated embryos. We are the conservator and protect the embryos while never making any disposition decisions regarding their fate. We never own the donated embryos and we encourage all embryo donation facilities adopt this model of conservatorship.”

      When I discussed the above model, which we have been performing for over 11 years, to the American Bar Association Family Law Section during a presentation in Miami this year, they thought the concept was ideal and encouraged me to “take it on the road.”

      I do have a call into Dr. Z. but he has not had a chance to get back to me. To the best of my knowledge, we have never met. My decision to discuss the mode of operations at CC was painstakingly done over one year and RELUCTANTLY decided. I NEVER wanted to write against a fellow REI. I never wanted to be perceived as simply being concerned about competition. I have taken great risks making a stand for fear of harming my reputation by commenting on another physician practice.

      We are a profession and, by definition, are to self-regulate. After the L.A. Times article came out minimizing the concern of so many, I thought I needed to take a stand before we truly begin to see embryo banks across the country or before legislative consequences occurred.

  • Jackie:

    As a hopeful future patient of California Conceptions, I fail to see the ethical concerns that you have regarding this program.

    In a traditional IVF cycle, a dozen or more embryos may be created with the intent of using only 1 or 2. The remainder may be donated to other couples, but in reality, most are either destroyed or frozen indefinitely. Many embryos are created with the intention that only a few will ever be given the chance at a life.

    My understanding of the CC program is that every healthy embryo will be implanted into a women and given the chance to develop into a baby that will be loved and cherished my parent(s) who desperately want a child. Most embryos have “intended parents” before they are even created and the ones that are frozen only remain so for a short time until they are matched with parent(s). This seems like a better ethical approach to me since all embryos created will actually be given a chance at life as opposed to being frozen for all eternity.

    Quibbling over who does or does not “own” the embryos seems nonsensical when the most important consideration should be what percent of these created embryos will ever be given a chance to become human beings. I think CC wins hands down in that regard!

    • Wouldn’t you like to own the excess embryos for a future sibling? Would it be that hard to modify the program so that you could do just that? Wouldn’t this be the best of all worlds?

      The ethical issues are important. Who owns the embryos is extraordinarily important. These are not just my concerns. The Ethics Committee of the American Society for Reproductive Medicine will be weighing in on this topic in January of 2013. Perhaps you are right and they will side with the decision that creating embryos, calling them donated embryos and then storing the excess embryos to be owned by the clinic will be ethically appropriate. If, however, they do not agree, would you agree that I was not a lone voice regarding my concerns?

      Good luck with your cycle at CC. Truly, I hope it works wonderfully and I hope there will be no excess embryos that are added to their small, but existing, embryo bank.

      • Tess:

        I find it disingenuous that you draw a line between the “donor bank” at CC, which has patients lined up for embryos, and will clearly have quick turn over, and the extensive “donor banks” at thousands of clinics of patients who cannot endure the thought of adopting their embies to anther couple or defrosting them.

        How much of these concerns are ethical and how many of them are specialists concerned with imaginary legislation? or worse, are you concerned about a competitor? Are other specialists concerned? This service is a needed one, and could undercut the bottom lines of clinics who offer egg donation cycles for 35K.

        I also find insulting your question of “don’t you want your child to have a sibling?” Clearly you do not understand that many people are past the genetic link, cannot afford 35K for donor eggs, and simply want a family. CC is cost effective because of how the program is organized. The cost effective nature of the clinic is necessary for people who have already gone 100K or more into debt.

        • Tess:

          There are differences between an “embryo bank” and the facilities that are holding cryopreserved embryos for the patients who own them. Where you are correct is that it is so very unfortunate that half of all cryopreserved embryos in this country will not be used by the patients who created them and that about one-third of them will be discarded or abandoned. I have been working for about eleven of years to try to change the conversation and change this pattern. You are right. Such a situation is not ideal nor is it good. The existence of one problem, however, does not give permission for the existence of another.

          Imaginary legislation? Just Google “Personhood amendments” and see just how imaginary it is. Be sure to visit RESOLVE’s website to find out that we are suffering from the same delusions.

          I have already addressed the “competitor” concern in other responses as well as the original blog itself. It would seem that because I am perceived as a potential competitor, located on the other side of the country, it means that I am not allowed not speak up when I feel something unethical is taking place.

          I am well aware of the cost issues. It is why I structured our embryo donation program to be as inexpensive as it is. Our website gives a range for anonymous embryo donation between 7-8K. The reality has been that patients are paying closer to 5K because we prefer to list potential costs that are not realized than perform a “bait-and’switch.” With CC increasing their costs to 12.5K within one month, how do you claim I am being insensitive to the cost issues? Curious, indeed.

          Is anyone thinking of solutions that could address all the concerns?

          Consider 12 fresh donor/donor embryos available and split to four recipients, providing 2 embryos per recipient, leaving 4 embryos needing to be cryopreserved. Are you telling me that the consents couldn’t be structured such that at least one of the four recipients will agree to accept the responsibility for remaining four cryopreserved embryos for $X extra dollars? If more than one recipient from this group wants the remaining cryopreserved embryos, could the embryos be divided equally or could a simple lottery be developed for the small group of recipients? In this way, the following occurs:

          • CC doesn’t own the embryos
          • The patients will decide disposition decision and not a medical practice
          • If the patients conceived, they truly have a chance of a genetic sibling in the future
          • If the patients do not conceive, they have embryos available from the original combination of the sperm and egg donors that the agreed to use
          • CC makes the profit that it feels it needs to make
          • The patients realize the savings potential that you have written about
          • Legislative changes are no longer needed
          • Ethical practices and standards of care are adhered to
          • The slippery slope is avoided hopefully minimizing the chances that embryo banks will be created and then closed as they were in 1997

          I am certain there are other solutions. I am certain that with so many bright minds out there that a better solution could be discovered then the couple that I offer above.

          I am curious with the number of negative posts over the past 24 hours. While there are a number of supporting blogs, supporting posts and having spoken to dozens and dozens of mental health professionals, ART attorneys, embryologists and reproductive endocrinologists that share my view, I can’t help but wonder if there is an organized effort to attack this blog. In fact, some of the attacks here are becoming personal. My concerns for CC are not personal. I don’t believe I have ever met any of the physicians who work there. My concerns are only with the system they have created and the potential consequences that may take place.

          So, I would woud like to ask the readers to try placing more time, effort and emphasis on finding solutions rather than trying to shoot the messenger. This will be for the good of all.

  • Anonymous:

    I find it very interesting that you took the time to blog about your opinion of a clinics practices without ever contacting the clinic to gain any firsthand knowledge. When I google your clinic some less than complimentary reviews come up from previous patients. Should I base my opinion of you and your practice on that?

    My husband and I tried for years to get pregnant using donor sperm with no success. When we decided to add donor eggs to the mix we knew we only wanted one (two only in the case of twins) child. If we went to a traditional egg donor we would have to decide what to do with the remaining embryos and we didnt want to be faced with that. We chose CC and haven’t looked back.

    For you to pass judgement on a clinic without finding out for yourself what’s really going on there is misleading and inappropriate.
    Our child(ren) will know exactly where they came from which will illustrate to them how badly they were wanted. Unfortunately now one day they are going to google CC and find the judgemental uninformed opinions of one of their competitors, a supposed expert in the field, and have to second guess their origins. Thanks for that.

    • Anonymous:

      I’m afraid you are not correct. In fact, the American Society for Reproductive Medicine and the Society for Assisted Reproductive Technologies were the ones that investigated the clinic. As neutral observers and guiding societies, I thought it would be far better for them to do this than me. I raised a concern but it was their investigation into the process that confirmed our initial worries.

      The wonder of your child has not been diminished. The fact that you used CC is simply the method that you decided upon respecting your desire to minimize the number of cryopreserved embryos left over.

      As previously explained, my decision to discuss the mode of operations at CC was painstakingly done over one year and RELUCTANTLY decided. I NEVER wanted to write against a fellow REI. I never wanted to be perceived as simply being concerned about competition. I have taken great risks making a stand for fear of harming my reputation by commenting on another physician practice. The issue, however, is far larger than CC or EDI for the potential consequences to the IVF field are significant and far reaching potentially influencing access to reproductive care to patients such as yourself.

  • I know that well-meaning people can have vastly different perspectives and therefore different opinions on ethical issues that arise with ART. I am grateful that Dr. Sweet is bringing up controversial topics–apparently hitting some nerves–but I think we need to continue to ask these and future questions. I think that we owe patients continued thoughtfulness about how we do ART. To this end, we should continue to have more transparency about the nuts and bolts of how we offer ART services in this relatively unregulated medical environment. Let’s make sure to encourage continual self-examination of our services and not shout down those that ask the hard questions within the field. Best Wishes.

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