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Embryo freezing: ethical issues in the clinical settings.

Embryo Freezing: Ethical Issues in the Clinical Setting

Only four years ago, embryo freezing (cryopreservation) was considered a technique raising "disturbing," "extremely difficult," "incredibly complex," and even "nightmarish" ethical issues. Currently, however, at least 41 of the 169 infertility clinics in the United States have added freezing to in vitro fertilization (IVF) protocols. [1] The number of frozen embryos in this country nearly tripled from 289 to 824 between 1985 and 1986. [2] An estimated ten infants in the U.S. and sixty in the world were born as of 1988 after having been frozen as embryos. [3]

Some physicians have concluded that freezing eliminates ethical dilemmas by allowing embryos to be stored rather than discarded, and researchers have contended that freezing poses few unique dilemmas. [4] It is true that if we look for evidence of public ethical controversy, predictions of perplexing quandaries have not, apart from the case of the Rios's "orphaned" frozen embryos in Australia, been realized. In the clinical setting, however, unanswered questions suggest the need to keep alive the ethical debate about the benefits to patients and society of embryo freezing.

Questionable Benefits

During a woman's initial IVF cycle, three or four of the embryos created are transferred to her uterus, while the rest are frozen for storage, to be thawed and transferred at a later date. Practitioners of IVF justify freezing as enhancing their ability to act in the patient's best interest. [5] In general, they presume freezing will benefit the patient physically, emotionally, and financially.

In theory, because not all embryos need be transferred in the first IVF cycle, freezing physically benefits a woman undergoing IVF by reducing the odds that a multiple pregnancy will occur--letting the patient recover from the stress of IVF before a second transfer of embryos, and sparing her repeated ovarian hyperstimulation and egg retrieval surgeries (laparos-copies). [6] It furthers the patient's emotional needs by reducing anxiety when she knows she has succeeded in one part of IVF and has tangible evidence, in the form of stored embryos, of that success. Finally, the patient benefits financially in that freezing avoids repeated start-up IVF expenses of hormonal monitoring, laparoscopy, and time lost from work during the two-week IVF cycle.

There is a real distance between theory and practice, however. Clinics report freezing an average of fewer than three embryos per patient. From one-quarter to one-half of these embryos do not survive freezing and thawing in established centers, and the attrition rate is undoubtedly higher in newer centers. Thus an optimal scenario of freezing, in which around six embryos are stored for leisurely transfer over a period of months, has yet to be realized. [7]

Does freezing actually benefit the patient physically? No injuries such as uterine infections from the transfer of thawed embryos have been reported, but neither does the evidence demonstrate that freezing significantly reduces the physical stresses from IVF for patients. There are insufficient data to conclude whether the use of thawed embryos is correlated with fewer miscarriages or multiple pregnancies. Moreover, the reduction of hormonal stimulation and laparoscopy may be less than expected, since mild medication may be needed to prepare the uterus for embryo transfer with thawed embryos. [8] And due to the attrition rate of frozen embryos, the patient may have to undergo the rigorous initial IVF cycle only to be spared, at most, one repeat cycle.

Does freezing benefit patients emotionally? Physicians presume that patients build defenses against disappointment when embryos are stored, but some women do just the opposite and "enhance" the embryos by coming to see them as babies. Patients may develop attachments to their embryos during regular IVF, as indicated by their naming the embryos, asking for the petri dishes in which the embryos were fertilized as mementoes, acting and feeling pregnant after the embryos are transferred to their uteruses, and mourning the embryos' loss if they do not implant. Freezing has the capacity to enhance rather than diminish such bonding.

Bonding poses problems if clients need to stop embryo freezing prematurely. Couples in freezing programs are warned that they may divorce or lose a spouse and therefore need to agree about what should be done with their embryos in such an event. They are also asked to accept the consequences of failure of freezing equipment, which would result in loss of the embryos. They are not, however, necessarily prepared for unexpected reasons for discontinuing freezing, as when the wife has a hysterectomy, is prematurely menopausal, or develops other medical problems precluding a pregnancy. Additionally, the costs of freezing might become excessive for the couple or they may have a multiple birth after the initial IVF cycle, adopt a child, or decide the strain of trying to circumvent infertility is too great and stop the process.

Anecdotal evidence suggests that the presence of frozen embryos is not necessarily like money in the bank, with more being better, for clients who find they must decide what to do with spare or unneeded embryos. Will the couple experience remorse or guilt by ordering the destruction of their embryos? If donation is an option, will they later regret donating their embryos to other couples? It is not clear whether couples easily affirm this anticipatory decision when the need to discontinue freezing is at hand.

Freezing also increases the patient's dependence on IVF as the answer to infertility in a way that can be emotionally unhealthy. Nurse coordinators have written of the need to counsel patients about resolutions to infertility treatment other than a pregnancy and birth, such as adoption or acceptance of infertility [9] Freezing interferes with closure on infertility for women who want to adopt or move on to other life goals but who find they cannot terminate the effort because of stored embryos. It also locks patients into treatment at the clinic where their embryos are stored even if they lose confidence in the program or feel pressured, either by clinic staff or by their own desires for pregnancy, to continue to try IVF.

Embryo freezing places women and men in the role of pioneers in uncharted psychological waters. By bidding technicians to judge embryos for their "freezability," it opens embryos to evaluation and encourages patients to evaluate their own self-worth (already assaulted by the legacy of infertility) by the number and quality of embryos they have stored. The embryo's appearance (regular or irregular? favorable or unfavorable? [10]) is a strong predictor of its ability to survive the freeze and thaw. Self-recrimination, which is already underway during IVF when women evaluate themselves on the basis of the number of follicles or eggs they produce, can be extended and broadened by embryo cryopreservation.

Embryo freezing also prolongs the experience of being a "patient" inasmuch as a genetic part of the couple is in the hands of an infertility clinic. This can add to couples' feelings of vulnerability and dependence by causing them to worry about embryos stored in a laboratory (fearing damage to the embryos or a mix-up of ampules).

The financial benefits of freezing are also questionable. Freezing can save couples thousands of dollars in start-up costs if a sizable number of embryos are frozen and survive the freeze/thaw, and if the couple is paying out-of-pocket for IVF. However, as noted, these conditions are usually only imperfectly met. Not only are few embryos frozen, but pregnancy rates appear slightly lower (or at least not demonstrably higher) for thawed than fresh embryos. [11]

Even if survival and implantation rates were high, freezing would save couples money only if it put them one step ahead of insurance coverage. If, however, the couple has access to insurance coverage that pays most of the estimated $5,000 for each cycle, but refuses reimbursement for the still-experimental procedure of freezing embryos, then the couple will pay out-of-pocket for the preparation, storage, and thawing of embryos.

Thus, although freezing may save couples money in the long run, in the short term it perpetuates a traditional problem of IVF in which, with the absence of federal funds for research involving human embryos and the inhospitable political climate for such research, the clinical application of IVF and its innovations precedes controlled studies using human embryos. [12] Freezing will place couples one step behind insurance coverage unless, as in Arkansas, cryopreservation is explicitly included as part of an IVF protocol or couples are given a maximum benefit level for IVF to be spent at their discretion. [13] Moreover, couples are billed for freezing irrespective of the outcome. If the machinery malfunctions, or the couple donates the frozen embryos to other clients or to the hospitals for study, or asks that they be discarded, the couple will still have paid for preparation and storage costs, which can run over time to hundreds or thousands of dollars.

Reservations about the physical, emotional, and financial benefits of embryo freezing raise questions about whether it is always in the best interests of patients and couples and how, if it poses harms as well as benefits, freezing can be practiced in a way that truly serves their needs. Should not their interests be an integral part of the criteria used to set up and administer freezing programs? What ethical obligations do practitioners have to their patients and to couples in deciding how to administer such programs?

Clinical Policies

Expediency, medical hunches, and the need to guarantee the program's future play a large role in how policies are made in pioneering freezing programs. Policies of innovative centers are passed to other centers in a lateral modeling through discussions among colleagues or through contracts with or workshops sponsored by well-known embryologists who pass on their programs' consent forms and policies. In lateral modeling, however, careful weighing of the physician's obligation to patients becomes lost in the effort to do what is expedient, efficient, and effective in other centers. A global notion of presumed beneficence replaces an individualized search for demonstrated beneficence.

Despite this modeling method, clinical policies exhibit a variety of approaches on a range of issues. Will a limit be placed on the number of years embryos are frozen? One center, for example, freezes embryos for a maximum of five years as a compromise measure between the two years proposed by some members of the hospital's ethics committee and the reproductive life cut-off favored by others. Others limit freezing time to avoid being in the "long-term storage business" or because they fear couples will move and abandon their embryos, leaving the program in an awkward legal position. Still others do not impose time limits to "keep our options open."

Most centers require couples to sign detailed consent forms stipulating the disposition of the embryo; others do not, arguing that such consent would be legally unenforceable in any event.

Should clinics charge for the procedure before they achieve their first success? Some centers do not charge for freezing or charge only a nominal amount until a clinical pregnancy results. Others charge up to $1,000 when setting up the program.

Should patients have the option of donating extra embryos for research or to other infertile couples? Some centers do not allow donation of extra frozen embryos; others require it as an alternative to discarding the embryos.

The physician's obligation in administering embryo freezing programs is to identify the patient's interests and integrate those interests into decisionmaking. This requires modesty about freezing's benefits for individual patients. It also requires a recognition of the pressure of unresolved societal dilemmas about working with human embryos that have implications for the needs of patients.

Freezing: Routine or Optional

Is it ever in the patient's interest to present freezing as a normal part of the IVF protocol rather than as an option? Directors report that over 90 percent of patients with spare embryos elect freezing, which indicates that freezing is presented in a way that encourages patients' participation in the protocol (for example, by stating "our policy is to freeze embryos in excess of four"). Yet this leads to concern about how detailed the information given to patients about the risks and uncertainties of the procedure actually is. An examination of consent forms confirms that, at least in writing, patients are given the most general information (for example, the risks are unknown, freezing has worked for animal models, the benefits "we hope" are to increase the chance of pregnancy).

It could be argued that generalized information (which in effect presumes the goodness of freezing) is more helpful than specific data that are too premature or sketchy, given the newness of embryo cryopreservation, to give accurate guidance. Some practitioners also contend that presenting freezing as an accepted part of IVF will save clients from the responsibility of making yet another decision in the already stressful IVF cycle.

The often-expressed presumption in IVF that the infertile patient is "desperate," "willing to try anything," and in need of urgent action due to her "ticking biological clock," seems to negate providing detailed information to her. Such views do not, however, justify withholding from clients detailed information about choices with respect to embryo freezing. The couple is not, in fact, in an emergency medical situation, and decisions need not be made under pressure if patients express their choices at the start of the IVF cycle. Moreover, the data are not so complex as to overwhelm most patients. While the legacy of infertility may indeed leave women in psychological distress with feelings of diminished self-worth, depression, and anxiety, others exhibit high ego-strength and a need to accumulate information about the procedures in which they participate. [14] Where patients do perceive themselves as desperate, this ought to signal caution, not permission, about freezing and the desirability of conveying full information to the patient about the experimental nature of the procedure.

Another reason for full disclosure of information, even if that information is sketchy or seemingly not desired by the patient, is to check on unseemly incentives for offering freezing. There are many motives for freezing--enhancing a program's prestige, setting the stage for research, bringing in fees to be funneled back into the IVF program--and patients are needed to meet these goals. Hence, the exploitive dissembling that has occurred in regular IVF and ambiguity over pregnancy rates [15] is repeated in freezing when directors give global success rates only and do not itemize success rates at each stage of the freezing procedure.

Physicians, then, must integrate into their protocols avenues for enhancing the patient's choice about whether or not to freeze spare embryos. The information on freezing should be given at the beginning of the cycle (not after the laparoscopy, when there are time constraints on decisionmaking). It should include full information about costs, including whether the storage fee is for each embryo or for all embryos, indefinite or subject to periodic renewals, constant or subject to cost-of-living adjustments, and inclusive of thawing and transfer fees. Most importantly, it should contain written information about risks and success rates at that particular center, including the average number of embryos frozen at the center per patient; the number surviving the freeze/thaw; the number of thawed embryos transferred to patients; the number of clinical pregnancies and births with thawed embryos; and comparisons of pregnancy, birth, and pregnancy and birth complications for fresh and thawed embryos.

If the center is too new to have such data, the director should provide global data and data from one or two middle level centers (not just from the most successful centers). The patient should also be informed about freezing outcomes for women with situations similar to hers. Are embryos more likely to survive the freeze/thaw if the woman is stimulated with certain combinations of hormones? Are some couples more likely to produce morphologically sound embryos than others? Where data are not available, patients should be advised that many questions about freezing remain unanswered.

The Meaning of the Embryo

Lingering questions about the nature of the human embryo affect communication within the IVF/freezing program, and suggest that the physician recognize the broader societal context when making decisions about embryo freezing programs and respect the differing perceptions of the embryo that intermix in the clinical setting. To clients, the embryo symbolizes hope and potential parenthood. It affirms the wife's femininity, the husband's masculinity, and the couple's potency. It is a powerful symbol with which clients establish emotional connections. It may be the closest thing to parenthood the wife and husband experience.

To physicians and scientists, the embryo is a collection of cells with distinct properties relating to its stage of development. [16] Its morphology is evaluated on its predicted ability to cleave, grow, and survive the freeze/thaw, and evaluations are made on this basis. An ongoing question, for example, is whether technicians should transfer the strongest embryos while they are fresh and freeze the weaker ones (this makes sense if most embryos do not survive the freeze/thaw), or transfer the weak embryos and freeze the strong ones (which makes sense if the strong embryos will survive and can be transferred to the woman at a later, presumably more receptive cycle when she has not been hormonally stimulated). [17] The importance of an embryo's appearance in predicting success rates places technicians in the position of identifying the criteria of an embryo that "looks good" or "looks odd," and this adds another qualification to the embryo's "worth."

Freezing creates an ironic situation in which clients tend to personalize their embryos over time and physicians tend to depersonalize them as they evaluate the embryo's freezability. These different perspectives may reduce meaningful communication between patient and doctor because one is using subjective criteria for making decisions and the other objective criteria. In deciding the disposition of unwanted frozen embryos, for example, couples who develop attachments to their embryos (especially if they have had a child through an earlier IVF cycle) may "see" donation of embryos to other couples as akin to giving a child for adoption, or "see" discarding the embryo as akin to abortion. A physician unaware of these perceptions may decide what choices to offer couples on the basis of expediency and with diminished sensitivity to their emotional attachments.

The legal dimensions of embryo freezing add another "personality" to the embryo. In 1984 the American Fertility Society advised that concepti are the property of the donors. [18] Following the Rios's case of ownerless embryos, IVF programs integrated language about ownership and property into consent forms, stating, for example, that "each embryo shall be the joint property of both of you, as the wife and the husband, who are deemed to be the legal owners." Couples who freeze embryos are asked to provide for the disposition of their embryo-as-property in the event of death or divorce. On the one hand, this personalizes the embryo as a potential child by bidding the couple to take responsibility for it. On the other, it commercializes this responsibility by defining it as one between owners and property.

The varied meanings of the embryo and the amalgam of language used to describe embryos (clients naming them "twins" or "preemie," doctors calling them "sets of tissues" or "pre-zygotes," and consent forms referring to "property" and "owners") reveal the moral uncertainty still underlying activities involving embryos. This uncertainty is heightened by language referring to the embryo's destruction. Some centers are euphemistic (for example, "You should be aware that the embryo that is thawed and not transferred will not undergo further development") and others are blunt (embryos will be "destroyed" or "disposed of"). Some centers refer to "ethical methods" of embryo disposal, without specifying what these methods are. Others give the clients the option of overseeing embryo disposal, as if in a ritual of death. All this conveys confused messages that hinder communication. If, for example, the embryo is a "mere" set of cells or property, why do program personnel hedge when talking about its destruction? If this is done to avoid arousing public attention, what is the effect on communication within the IVF center?

The implication is that much uncertainty continues to underlie cryopreservation in IVF centers: Ethical dilemmas remain unresolved and misunderstandings arise from faulty communication. The patients will bear the brunt of techniques used before the moral meanings are understood in the public debate. It may be in the patient's interest for physicians to depersonalize the embryo and use scientific language to prevent unfruitful and probably disappointing bonding. However, this runs the danger of closing communication between physician and patient that would reveal the subjective but morally significant perspectives of patients.

Open and frank discussion among ethics committees, patients, nurse coordinators, and physicians is required to resolve the question of the many meanings of the embryo. A pragmatic, honest language is essential, one that does not disguise the embryo (in itself an acceptable term) either by personalizing it (for example, calling it "little one") or depersonalizing it (by calling it "the pre-zygote"). Honesty is also served by forthright communication about what will be done with embryos no longer needed. False propriety does little good, as when consent forms state that embroys will be "disposed of ethically," but the method is unstated and staff members cannot articulate what an ethical method of disposition is. If it means a passive act (exposing the embryo to the air so it will disintegrate) rather than an active move (washing it down the sink), this should clearly be included in the consent form by stating, for example, that unwanted frozen embryos will be exposed to light and will distintegrate in a given amount of time.

Beneficent Embryo Freezing

The growing field of alternative conception owes its energy to mixed forces, including the demands of patients, scientists' yearning for discovery, physicians' interest in satisfying patients' needs, lucrative possibilities, and public fascination with technology. At a basic level, however, it is the physician operating in the infertility clinic who makes everyday decisions that affect whether the techniques will serve or detract from societal interests. [19] Where physicians adhere to traditional notions of virtue in presenting freezing in the clinical setting, they take an important step toward integrating it into society in a way that will promote its promise. However, when they make ad hoc decisions with the clinichs interests primarily in mind, overlook the emotional side-effects of the technique, and presume the benefit of freezing, patient and societal interests are ill-served.

With normalcy and routine comes a diminished will and inclination to question the ethical dimensions of embryo freezing. The subtle ethical quandaries that arise in freezing programs are in danger of being overlooked in the absence of highly visible crises. Already ovum freezing is being presented as an innovation that raises no ethical issues and negates the need for the more problematic embryo freezing. [20] To see in new techniques a way of reducing dilemmas is to fail to question the virtue of the model already being built. Where dissembling, ambiguous language, untested presumptions, and narrow medical criteria combine in the clinical setting, there is diminished opportunity for enlightened debate about the value of freezing and its technological successors for society as a whole. Clinical interactions are gatekeeping interactions. They ought to be developed and refined on the basis of ethically defensible criteria in which the observed needs of patients play a central part.

References

The author wishes to acknowledge the financial help of The American Philosophical Society and The National Endowment for the Humanities in gathering interview material for this article.

[1] Andrea L. Bonnicksen and Robert H. Blank, "The Government and In Vitro Fertilization (IVF): Views of IVF Directors." Fertility and Sterility 49:3 (March 1988), 396-98. Of the 88 directors who responded to the survey in early 1987, 41 already offered embryo cryopreservation and most others planned to offer it within two years.

[2] Medical Research International, The American Fertility Society Special Interest Group, "In Vitro Fertilization/Embryo Transfer in the United States: 1985 and 1986 Results from the National IVF/ET Registry," Fertility and Sterility 49:2 (February 1988), 212-15.

[3] U.S. Congress, Office of Technology Assessment, Infertility: Medical and Social Choices (Washington, DC: U.S. Government Printing Office, 1988), 298.

[4] Alan Trounson, "Preservation of Human Eggs and Embryos," Fertility and Sterility 46:1 (July 1986), 1-12; John A. Robertson, "Ethical and Legal Issues in Cryopreservation of Human Embryos," Fertility and Sterility 47:3 (March 1987), 371-81.

[5] Although technically the "patient" in IVF is the husband and wife as a couple, for clarity in the following pages attention is directed to the female partner as the patient.

[6] Jacques Testart et al., "Factors Influencing the Success Rate of Human Embryo Freezing in an In Vitro Fertilization and Embryo Transfer Program," Fertility and Sterility 48:1 (July 1987), 107-12; Robertson, "Ethical and Legal Issues," 371.

[7] Medical Research International, "In Vitro Fertilization/Embryo Transfer in the United States," 213; Testart et al., "Factors," 109.

[8] Testart, et al., "Factors," 108.

[9] See, for example, C.H. Garner, "Psychological Aspects of IVF and the Infertile Couple," in Foundations of In Vitro Fertilization, Christopher M. Fredericks et al., eds. (Washington, DC: Hemisphere Publishing Corporation, 1987), 305-11.

[10] Trounson, "Preservation," 6; Testart et al., "Factors," 111.

[11] Trounson, "Preservation," 5; Testart et al., "Factors," 111.

[12] Susan Abramowitz, "A Stalemate on Test-Tube Baby Research," Hastings Center Report 14:1 (February 1984), 5-9.

[13] Office of Technology Assessment, Infertility, 151.

[14] Garner, "Psychological Aspects"; Ellen W. Freeman et al., "Psychological Evaluation and Support in a Program of In Vitro Fertilization and Embryo Transfer," Fertility and Sterility 43:1 (January 1985), 48-53.

[15] Michael R. Soules, "The In Vitro Fertilization Pregnancy Rate: Let's Be Honest with One Another," Fertility and Sterility 43:4 (April 1985), 511-13.

[16] Rafael I. Tejada and William G. Karow, "Semantics Used in the Nomenclature of In Vitro Fertilization, or Let's All Be More Proper," Journal of In Vitro Fertilization and Embryo Transfer 3 (1986), 341-42.

[17] Testart et al., "Factors."

[18] American Fertility Society, "Ethical Statement on In Vitro Fertilization," Fertility and Sterility 41:1 (January 1984), 12-13.

[19] Eugene B. Brody, "Reproduction without Sex--But with the Doctor," Law, Medicine and Health Care 15:3 (Fall 1987), 152-55.

[20] Trounson, "Preservation," 11.

Andrea L. Bonnicksen is a professor of political science at Eastern Illinois University, Charleston, IL.
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Author:Bonnicksen, Andrea L.
Publication:The Hastings Center Report
Date:Dec 1, 1988
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