The fertility industry is on the verge of challenges and changes brought about by the international controversy of embryonic stem cell research. The central issue is the 400,000 excess frozen embryos from in vitro fertilization awaiting a patient’s decision. This debate never existed until other parties wanted to stake their claim on these embryos (altruistically, scientifically, morally or economically).  But these embryos, in the care of their fertility clinic, belong to couples who had struggled to create them through IVF treatments and now are faced with a difficult, personal choice amid a heated public debate.  If you are among those patients or are considering IVF, you may want to become aware of these emerging issues and how they may impact your treatment.

During the past year, FDA regulations, Senate debates, movie stars and media, and a long list of states clamoring for research dollars converged on the private threshold of in vitro fertilization —  in the name of politics, business, religion and science. What remains to be seen is how this potent gathering of forces will impact a private medical decision. And how far will this encroachment be allowed to extend in the form of intervention and regulations, versus recommendations and guidelines. No matter what your personal beliefs about embryonic stem cell research, the door is open and the impact on IVF seems inevitable.  Several areas are emerging in the wake of this debate that may signal future changes: the number of embryos produced or transferred in IVF, competition for donor eggs, embryo adoption and informed consent.  These areas alone could have far-reaching ramifications for both doctor and patient.  

Limiting the Number of IVF Embryos

 The dilemma of the hundreds of thousands of excess embryos begins with the number of embryos stored.  Some have pointed out that the sheer magnitude suggests that the problem is really in how many embryos are created and transferred in the course of IVF, which further implies that IVF itself created the problem and therefore has the responsibility to restrict these numbers in the future.  A number of other countries already have such restrictions in place, that supercede the decision of the doctor or the patient in terms of the numbers of embryos created or transferred.  This is a reasonable consideration and one that improvements in the success rates of the IVF process will make more realistic. However, as most people who have gone through IVF are aware, the most difficult part of the process is usually the hormonal stimulation and the subsequent egg retrieval process.  When couples create extra embryos, they are doing so because they want to improve their chances of producing a viable pregnancy while avoiding the possibility of repeating the entire process.  Limiting the number of eggs which can be inseminated may require repeated ovarian stimulation, retrieval and transfer attempts, which means greater expense and more physical demands on the parents.  The number of embryos created or transferred is another doctor/patient decision that most IVF treatments already require. Some countries, typically the ones that provide fertility treatment as a covered medical expense, may limit the number of eggs fertilized or the number of embryos transferred.  IVF created the extra embryos, and now is called upon to produce and store fewer. Stem cell research purports to shift only those slated for destruction, but in reality, the debate isn’t just about discards, but all stored embryos. And the ultimate decision then becomes not whether to store or to destroy, but how extra embryos will be used.  The debate prompts couples to decide whether embryos created, but not used, for fertility will become highly-sought and debated research material or other people’s children.   

Supply and Demand for Donor Eggs

Older women who postponed childbirth or others who may need a donor egg to become pregnant may have to compete with researchers who also need donor eggs.  Alex Barnum of Scripps Howard News Service highlights this emerging challenge for IVF in the wake of Stem Cell Research “If women who sell their eggs to infertile couples can make as much as $30,000 to $40,000, should women be compensated for donating their eggs to stem cell research?” ¹

Previous ethics recommendations had stated that the “purchase or sale” of eggs for research should be illegal.²  But that language has already been modified in the Stem Cell Research Enhancement Act to allow for expenses and to “compensate the donor …for the time or inconvenience.” ^3,4Therefore, the door has been opened for research donors to be compensated, and thus sets up the possibility that researchers and women who need donor eggs to become pregnant will be “bidding” for eggs.  And as the demand for the “choice” eggs of young, fertile women goes up, infertility patients will find it more difficult and more expensive to use a donor egg to become pregnant. 

Indiana Senators were debating a bill that would ban payment for eggs, and could drive women seeking donated eggs for fertility treatment to other states.   “Women should be compensated….If the bill is approved without his amendment…Hoosier women would be forced to find eggs out of state because he doesn’t believe donors would do this for just medical expenses.” ⁵

British researchers believe that women will donate eggs with or without compensation.⁶  But even without financial inducements, the altruistic desire to help others may also be exploited.  Some have cautioned, for example, that the women who are donating eggs for stem cell research must not be misled to believe that their donation is going to cure an ailing member of their family.  Should this same cautionary approach not apply to embryo donors as well?   It is possible to exploit altruistic desires and emotional connections to those who need cures. 

This sets the stage for yet another contention arising from some women’s groups who oppose research because young female donors may be exploited for their eggs, and thus lead to more stringent requirements for informed consent of egg donors regarding the process and the risks.  So while the debate continues in the supply and demand ethics for eggs, fertility clinics will not only have to consider the possibility of competition for eggs and higher costs, but also may need to reexamine education and consent forms to be certain that the new ethics of egg donation in the age of stem cell research are up to par with their standard fertility clinic processes.  Clinics should already have a standard clause to cover that, but that clause may or may not extend to cover subsequent donation to research.  Parents who received a donor egg or donor sperm to become pregnant may later want to consider donating their excess embryos after their IVF is complete.  Be sure that the right to make that decision is assigned to the birth parents of the embryo and that no further consents are required of the egg or semen donor.  If the initial contract with the egg donor does not specify that she is relinquishing the egg and the rights to the disposition of any resultant embryos, then a future donation would require that the egg donor be located (and that may be years later) to sign an embryo donation consent form, whether the couple is now wishing to donate for research or for fertility purposes. 

If you already have frozen embryos in storage and used a donor egg or sperm, you may have to find the original donor before you can donate to research or for infertility and that decision may be bound by the donor’s desires, not yours.  Current guidelines require that both the male and female genetic donor are required to give consent for research.  Which in the case of fertility treatment means that if donor sperm or donor eggs were used, those original donors must have given their consent.  Many of the 22 stem cell colonies currently available for federal grants were created using anonymously donated sperm.  Those donors most likely could not be located to give that consent, and therefore, many of those frozen embryos in storage today would also not meet the National Academy’s standard.⁷

Informed Consent

Many IVF patients will eventually have to make the decision regarding their excess embryos from among these options:  Storage, disposal, donation for adoption or research.  However, all options are not universally offered by IVF clinics, as their own private practice decisions dictate what options are offered and how they choose to structure their legal consent forms.  It is that process of information and consent that has come into focus. 

Informed consent is part of the private communications process that occurs in the protected relationship between doctor and patient.  In this case, it suggests that doctors need to be sure their patients have unbiased information and fully understand all their options before they make a choice about what to do with their excess embryos.  How that information is conveyed and the consent forms involved are up to the discretion of the individual doctor.  Doctors are accustomed to making recommendations based on their education, experience and beliefs.  In the process of “recommending” what to do with excess embryos, the personal beliefs of the doctor or the available options through their practice may impact what and how the information is presented.

Stem cell research principles that have been recommended by Senator Bill Frist (and others in different language or contexts) “require a rigorous informed consent process.”   If it is “required,” is this now moving from recommendation to legislation?  And what is “rigorous?”  A study course and exam before the patient can be treated? Communications requiring unbiased presentation of all options?  One thing is certain, most groups resist interventions and requirements.

Clinics that now offer only “default” clauses may be challenged both by patients and the public in the quest of being fully informed.  Consent forms and practice options vary widely, and some, for example, currently will offer only research — and those patients who do not choose research then choose destruction by default. Others offer embryo donation passively, upon the request of the patient.  Studies suggest that even of the clinics that report offering embryo donation or adoption, far fewer have actually implemented the practice. And some would like to offer it, but feel that the number of donated embryos they have for adoption would not justify it.  Offering extended storage or donation is becoming easier through third party groups and would hardly dent the clinic’s own research or storage supply, with current figures of embryo donation at about 2 percent.  Other clinics do not offer destruction as an active practice or may simply return embryos for the patient to dispose of.  But as in the current fight over prescribing “morning after” pills, the moral objections of physicians may also come under pressure. 

The fact is that the business of fertility is more about facilitating pregnancy and creating viable embryos than about stem cell research or destroying embryos.  That’s why fertility doctors practice IVF.  And that’s why patients see them. But informed consent may require the patient and the IVF doctor to consider areas that were not their primary concern.  The IVF patient is already overwhelmed with information and their primary focus of having a baby.   Some current recommendations even specify when the doctor should counsel the patient on their options.  While it is ideal to seek a decision early in the IVF process, the reality is that during IVF treatment, the couple is just too consumed with more important concerns  — like having a baby.

Further, the consent process itself has other implications, including the interpretation of the wording and the converse choice it conveys.  If you are choosing to donate to research, you must also be choosing that “embryos be barred from the womb,” writes Louis M. Guinin in his upcoming article in the journal, Stem Cells, and “that a woman’s decision declining transfer of her externally created embryo into her, or into anyone else is a morally permissible exercise of discretion; and that an embryo barred by such a decision from the womb…cannot gain anything from being classified as an actual person,” states Guinin, co-chair of the ethics committee of the International Society for Stem Cell Research who has written extensively on the morality of the use of embryos in medicine.⁸   To fully understand the decision that one makes when deciding what to do with extra, unused embryos, one should perhaps go as far as to point out that such a decision does in fact pronounce whether one views embryos as potential children that may be raised by others or that by banning them from any womb “declassifies” them as actual or potential people and destroys them.  To omit or to idealize the terms involved is a disservice to the importance of this decision, and if not dealt with directly during the consent process could make the decision even more difficult.      

For couples with embryos in storage, it may seem easier to continue to pay the annual storage fee. But often that annual storage bill does spur the decision process for those who have already concluded that they will not be using their stored embryos for a future pregnancy.  While the clinic may contact the couples and make them aware of donation or disposal options, it is ultimately the couple’s responsibility to actively pursue those options.  Right now, donation for research or for adoption by another couple requires many couples to become proactive, to review the legal implications, and to take the necessary steps.

There are two different kinds of programs offered by national centers specializing in embryo donation and adoption.  One is an adoption referral or matching services that require a home study and then will match up a couple with extra embryos to another couple who needs embryos to become pregnant. The second type offers donation/adoption services through a medical facility that provides shipping, storage, and the medical transfer of the embryos to another couple, and also requires home studies of the adopting couple. The adoption may be arranged openly where both parties are known to each other or arranged with specifications by the donor designating geographic or other restrictions, anonymity, or whether future contact is desired or not.   Information may be found by searching the Internet for the term “embryo donation.” 

While pressures surrounding stem cell research grow, there is no national center that can assist couples wanting to donate their embryos for research, and very few fertility clinics have their own approved research programs. This can mean that embryos for research are really stored in limbo or may be used for “research” purposes outside of what the couple may have desired — including the training of laboratory professionals.  Any clinic conducting research must have received Institutional Review Board approval that ensures ethical standards are met.  If you are donating embryos to research, you do have a right to know about IRB approvals and the specific scope of the testing.  This does place more responsibility on the couple to find out about research options that are offered, and whether there are approved research programs currently in place.   

Public awareness may make both patients and doctors more proactive (an ounce of proactivity can prevent a pound of regulations.) This may signal doctors to reexamine consent forms, review education and information provided, and set up provisions for offering more options.  The informed patient that doctors see today is learning to ask for the drugs and treatments they want, and with this ongoing debate they will begin to ask for embryo options they want and request them if not included on clinics’ consent forms.

Implementing a new consent process will make life easier for future patients.  But a two-step consent process will be required to meet guidelines currently proposed, and that two-step process may make it impossible for any of those currently stored embryos to qualify for donation.  “Parents must elect to discard (embryos) them ‘prior to the consideration of embryo donation’ and only later decide to donate them for research,” according to a Chicago Tribune editorial.  None of those in storage may qualify under this standard. “Clinics don’t structure their consent process that way. Almost all of them ask parents to decide from several choices at the outset, before any embryos have been created.  Clinics can adopt this new two-step procedure…but it would affect only future embryos, which defeats the purpose of the bill.” ⁹

Awareness, Education, Ethics and Laws

The current debate has already led to a call for more awareness and education, which in turn translates into an examination of ethics which may ultimately be codified into laws. Three different international studies of patient’s beliefs and decisions regarding their excess embryos concluded that education was imperative.  As one study concludes: “The need for educational programs on issues relating to embryo donation to another couple has been raised previously. Our findings support this view, and suggest that programs should be extended to encompass all potential donation options, including medical research.” ¹⁰

This call for education, the number of “undecided” embryos (with no decision for future disposition or use), and the need for government grants to raise awareness may be symptoms of shortcomings in the current communications process.  While it is the patient’s right and responsibility to choose, this places a greater responsibility on the clinic to educate and inform.  Patients are more proactive than ever before in making their decisions, yet no amount of brochures or websites will replace the fundamental need to talk with a professional. That may account for the volume of calls received to the National Embryo Donation Center as patients bridge the gap in personal communications by calling to speak with professionals who are involved with this decision every hour of every day.  In less than one year, this new center received over 700 calls from 45 states and four foreign countries.  And this is in spite of the reportedly low interest in donating and adopting embryos. How much more would donation increase if only there were patient resources to alleviate the overload during the course of IVF?  

Couples making decisions need to understand basic facts and realistic science, and the odds of “success” for their embryos donated either to research or fertility.  That half won’t survive the thaw, that 30 percent will go on to become a viable pregnancy, and that a research embryo is less likely to be coaxed into a stem cell and very unlikely to produce a cure in the “near” future.

As Harvard stem cell researcher David Shaywitz points out:  “In fact, the deliberate conversion of human embryonic stem cells into any other type of cell remains a formidable scientific challenge….While stem cell advocates have helped voters connect embryonic stem cell research with compelling images of patients who might one day benefit from treatment, such therapies are unlikely to emerge soon enough to benefit most current proponents….the science is unlikely to keep pace with the eager expectations.”¹¹  

As far as all those frozen embryos are concerned, they are far less desirable than the fresh eggs used in the most successful research.  Further, some report that there are still far too few frozen embryos available for research to make a meaningful contribution to a cure. An article inScientific American last year said, “hundreds of thousands” of embryonic stem cell lines may be needed – which “could require millions of discarded embryos.”¹²  Currently, only 11,000 of those 400,000 are designated for research.  Which again underscores the question as to whether this profoundly personal and important decision will be based on full access to facts, or unrealistic hopes that would make the decision easier.

“There’s so much excitement, hope and, frankly, hype that patients are likely to be clamoring to get into the first clinical trials,” said Dr. Bernard Lo, director of UCSF’s Program in Medical Ethics. “But we don’t really know what’s going to happen. People could be made worse, as with any clinical trial. It’s important that people understand this is a longshot.”¹³

For a woman to believe that her donated embryo will help someone walk again would certainly make the decision easier, but unfortunately, the truth is far more complicated and involves far more considerations. While there are few laws governing embryo donation and adoption, the intensifying stem cell debates may bring closer scrutiny.  And if people are more willing to view their embryos as research material will they feel less tied by the notion of giving up their genetic child for someone else to raise?  Today, this qualm over “giving up” a genetic child is one of the barriers to donation. But in a brave new world, will we really be willing to give up the notion of embryos as potential children…even when this is the very essence of in vitro fertilization?   The comfort zone of using storage to postpone thinking about excess embryos is on the brink.  And quite simply, IVF treatment is not truly complete until this final decision of what to do with any unused embryos is made. The time to examine these issues has come, as these very issues may change reproductive choices we now take for granted as personal and private treatment decisions. 

Sources

1. “Stem cell scientists debate finer points of research ethics,”  Barnum, Alex.  Scripps Howard News Service.  28 June 2005
2. Stem Cell Research Enhancement Act of 2005, IN THE SENATE OF THE UNITED STATES.  28 February 2005
3. Stem Cell Research Protection Act.  21 April 2005
4. “National Academy of Sciences steps up to fill government void with ethical research guidelines,” Atlanta Journal Constitution. 
   05/03/05
5. “Lawmaker: Compensate Women for Embryos,” Indianapolis Star.  31 March, 2005
6. “Cloning Plan Poses New Ethical Dilemma. Scientist Courts Controversy with Call for Women to Donate Eggs,”  Sample, Ian and MacLeod, Donald.  The Guardian.  26 July 2005
7. “Stem cell scientists debate finer points of research ethics,”  Barnum, Alex.  Scripps Howard News Service.  28 June 2005
8. “A Proposed Stem Cell Research Policy,” Guenin, Louis M. Stem Cells Express. 2 August 2005. 
9.   “Stem Cell Debate Myths,” Chapman, Steve. Chicago Tribune.  5 June 2005
10.  “Patient attitudes to donation of embryos for research in Western Australia,”  Burton, Peter JBurton and Sanders, Katherine. MJA 2004; 180 (11): 559-561
11.  ”Stem cell studies hopeful but time needed for cures.  Overpromising research could jeopardize its future,” Shaywitz, David.  Houston Chronicle.  30 April 2005
12. “Stem Cell Research: Progress and PR,” Caruba, Alan.  MichNews.com    1 July 2005
13. “Stem cell scientists debate finer points of research ethics,”  Barnum, Alex.  Scripps Howard News Service.  28 June 2005