In IVF programs, excess embryos are almost always cryopreserved in order to safely and efficiently maximize the chances of pregnancy. Yet, embryos have accumulated worldwide and now number in the hundreds of thousands(3
). This study quantitatively assessed the intentions and attitudes of a geographically diverse U.S. sample of fertility patients toward cryopreserved embryo disposition. It revealed that fertility patients are likely to face an unanticipated conundrum when they have completed treatment: a choice among unappealing disposition options. In our sample, nearly half of currently stored embryos are not intended for reproduction, but good alternatives for embryo disposition are lacking: patients either prefer options not generally available to them, such as research donation, or reject available options, including reproductive donation or thawing and discarding. The factors that shape these preferences were identified, including a novel conception of responsibility that correlated with options resulting in embryo destruction.
In contrast to a recent national survey indicating that 87% of embryos are being stored for “patient treatment,”(3
) we found that only 67% of patients were likely (54% very likely) to use embryos for reproduction. More consistent with previous estimates, 86% of the subset of respondents wanting a baby was very likely to use embryos for reproduction. This differential reflects that reproductive decision making is a dynamic process: many patients who initially freeze embryos for reproductive purposes find that they no longer need them after becoming pregnant through IVF with fresh embryos or conceiving spontaneously (at an estimated rate of 12.5% over 36 months)(25
), or no longer want them due to changes in reproductive goals and life situation. Yet of the nearly 500 respondents not desiring future childbearing, 40% have yet to select a preferred disposition option, and nearly a fifth indicate they are likely to freeze their embryos indefinitely.
Our data point to a breadth of barriers to embryo disposition, including challenges that arise in the process of decision making, issues concerning the options themselves (availability and acceptability), and barriers to carrying out options once they are identified as preferable. An important challenge in the process of decision making is that when embryos are initially cryopreserved, patients are focused on having a child and may not be prepared to consider fully their views about embryo destruction or donation.(7
) Of the subset of individuals in our study who indicated intentions to have a baby, few think it very likely they will dispose of excess embryos: only 3-6% of respondents considered any disposition option very likely, with the notable exception of research (15%). Rather than delaying disclosure, consent for cryopreservation should acknowledge difficulties some patients have deciding among disposition options and, given that reproductive goals evolve, incorporate a system to revisit disposition preferences at regular intervals. Updated information on available options can be included in regular billing correspondence from IVF centers to patients with stored embryos. Given the complex nature of this process, standardized procedures and documentation for informed consent and interval follow-up should be developed.
A related challenge is that patients facing disposition decisions frequently prefer options that are not made available to them. Consistent with single site studies from Europe and Australia(26
), donation for research was the most popular option for disposition of excess embryos; considerably fewer respondents elect reproductive donation, or thawing and discarding. Yet only four of nine participating centers mention the possibility of research donation in consent documents for cryopreservation. In fact, our review of consent documents indicates that patients are often not asked their preference regarding disposition of excess embryos at the time of freezing. In these programs, consent for disposition happens at the time of donation or disposal. Discussion of disposition options is not mandated by professional guidelines. There are only two factors listed for discussion in the American Society for Reproductive Medicine's guidelines for frozen embryo disposition informed consent: the program's time limit, and disposition in the event of death, divorce, nonpayment, or loss of contact(27
). While such guidance was adopted partially in response to legal disagreements over cryopreserved embryos, guidelines should be updated to encourage early disclosure and periodic follow-up conversations about disposition options for cryopreserved embryos.
Another challenge to embryo disposition is that alternatives to research donation are not acceptable to most patients. Consistent with previous studies(14
), few patients in this study were very likely to choose the option of reproductive donation, despite federal funding in support of reproductive donation programs(30
) and avoidance of the perceived moral pitfalls associated with embryo destruction. Only 7% of participants indicated that they are very likely to choose reproductive donation; in contrast 59% were very unlikely
to choose this option. Our data help to explain the reluctance toward reproductive donation. The principal components analysis captured a domain that has previously not been measured, which we called “concerns for embryo, potential fetus or child.” Eight factors loaded on this domain; seven were thematically linked as fertility patients' expressions of “parental” responsibility – concern about or responsibility for the health or welfare of the embryo or the child it could become. Interestingly, this broadly endorsed domain was negatively associated with reproductive donation and positively associated with options not resulting in a child, including thawing and discarding and freezing embryos indefinitely. These findings highlight the necessity of offering options that result in embryo destruction, or limiting the numbers of embryos created or cryopreserved by screening embryos for quality prior to freezing. Going forward, public policy discussions about embryo disposition practices should broaden their scope to incorporate patients' notions of procreative responsibility.
The option of thawing and disposal was widely available but unattractive. This option was considered very likely by only 6% of respondents despite the fact that it is offered at all centers. Our data also help to explain reluctance toward disposal. Our principal components analysis captured a domain of altruism, which was positively associated with donation for research and donation to another couple, and negatively associated with thawing and discarding. Thus the powerful impulse to give back to society and to help others may make research morally preferable to individuals whose sense of responsibility precludes their allowing their embryos to become children in any family except their own. For those less strongly moved by the particular and intimate sense of responsibility, altruism leads them to donate embryos to another couple.
Our data also reflect the importance to patients of the actual process of thawing and discarding embryos, including a demand for ritual. A significant minority of patients preferred transfer of embryos to the woman's body at an infertile time or a disposal ceremony. These options, articulated in greater detail in our previous qualitative work(7
), were considered likely by almost as many respondents as the conventional options of thawing and discarding and reproductive donation. In contrast to conventional options, these alternatives are offered at less than 5% of U.S. clinics(22
) and were not mentioned on any center's consent document. Interestingly, these options were preferred by patients who both ascribed higher moral status to human embryos and higher importance to concerns about the embryo, fetus and future child. In order to limit increasing numbers of stored embryos, clinicians and policy makers should work to ensure that patients have access to a breadth of options, including research, reproductive donation, and alternative methods of thawing and discarding.
Finally, the popular option of research donation exemplifies challenges to carrying out preferred options. While 64% of U.S. programs indicate they offer donation for embryo research to their patients(22
), in reality this number may reflect what is likely to be an overestimate of the percentage of patients who actually have access to their preferred option. U.S. federal funding of research involving the destruction of embryos is currently restricted; therefore, U.S. scientists who rely solely on federal funding for their research may be unable to accommodate patients' demand for research donation unless these restrictions are lifted. In addition, research programs with other funding sources may currently face strict guidelines for informed consent. For instance, professional guidelines for stem cell research offered by the National Academies of Science(31
) and by the International Society for Stem Cell Research(32
) include robust provisions regarding provenance of gametes and embryos. These stipulations include informed consent from gamete donors, sanctions against the research use of embryos created using paid oocyte donors, and a requirement for explicit consent for stem cell research or specific research projects. In some institutions, consent must be obtained for donation to each individual research project, rather than for embryo research in general. Even if consent is obtained, the logistics and high cost of shipping embryos to research centers remains a barrier. Further, some patients may live in jurisdictions where embryo research is illegal. If effective therapies emerge from research involving human embryos, donation to research may become a more attractive option, and issues of access may become more pressing. Patients opting for the less popular option of reproductive donation face similar barriers, as FDA policy on infectious disease testing may preclude reproductive donation of embryos created before its requirement for extensive testing of gamete providers was established.
Although the nine centers that agreed to participate in this investigation are diverse with respect to geographic location, size, insurance mandates, and affiliation with academia and fellowship programs, patients treated at academic centers were overrepresented, and generalizations should be made with care. This consideration highlights a limitation of such a study. Nevertheless, this is the largest and only multi-site study directly measuring fertility patient preferences for disposition of cryopreserved embryos in the U.S., Australia, or Europe. In addition, since the study focused on individuals who currently have embryos stored, our findings may not reflect views of patients who have disposed of embryos or transferred them to a commercial storage facility. However, given the challenges that currently stored embryos entail for both clinicians and policymakers, we chose to focus on the views of individuals in a position to decide about the embryos that have accumulated. Finally, although our sample tends to reflect the homogeneous population that currently has access to fertility services, the study group is lacking in socioeconomic and racial diversity, thus limiting power to demonstrate significant differences in attitudes and preferences according to racial, ethnic, or socioeconomic characteristics. In demographic considerations, the only statistically significant difference was that non-whites were less likely than whites to keep embryos frozen forever. Future studies should focus on and elicit the attitudes and preferences of minorities with regard to reproductive decisions, so that their voices also inform clinical care and policy in reproduction and embryo research. Given the unacceptability of currently available options, future studies should also investigate what other disposition options would be more acceptable to women and men participating in IVF.
Notwithstanding these limitations, this study has important implications for clinical care and guidelines for embryo disposition. Many fertility patients will face a difficult and unexpected conundrum regarding embryo disposition. The options they face are either unacceptable to them, or other options which would be acceptable are not available. Too often the result is delayed decision making, the accumulation of excess embryos, and burdens for patients and providers alike. Strategies to address this situation include attention to informed consent processes for patients undergoing IVF, including early disclosure about the potential for excess embryos, more detailed disclosure about the available disposition options, and periodic follow-up including discussions with patients regarding evolving reproductive goals and values. In addition, broad availability of all options including thawing and discarding, reproductive donation, research donation and considerate processes for disposal is a critical goal to be facilitated at the levels of public policy and clinical care. In addressing federal restrictions on embryo research, policymakers should consider their impact on fertility patients faced with morally difficult disposition decisions. Programs not institutionally affiliated with embryo research or reproductive donation programs may coordinate with other programs that can accommodate patients' preferences when disposition decisions are made. Additionally, individual programs should develop protocols for considerate processes for disposal. These changes may not only reduce the numbers of embryos in storage and help to advance biomedical science, but may also facilitate disposition decisions that are morally acceptable to the majority of fertility patients. In the meantime, this study clearly reveals that individuals with cryopreserved embryos express considerable – and previously unexplored – concerns about the fate of their embryos. The results of this study emphasize the need for intensive restructuring of the informed consent process for infertility treatment that involves embryo cryopreservation.