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16

Assisted reproduction

Roxanne Mykitiuk and Jeff Nisker

Ms. F and Mr. G are trying to have a child. They have been through clomiphene citrate having approximately three times a has been practiced for over 30 years (Messinis, 2005). week for the past year, and daily around the time when This oral therapeutic strategy can assist 50–80% of Ms. F thinks she is ovulating. They are both 38 years old. women with ovulatory dysfunction become preg- Ms. F has had regular menstrual cycles up to the last three nant, depending on the etiology of their disorder months, in which she has had only two. They are worried (with the exception of premature ovarian failure) they have delayed starting a family too long and will not be (Messinis, 2005). Aromatase inhibitors are new oral able to afford the expensive fertility treatment they may ovulation induction agents (Casper and Mitwally, require at Ms. F’s age. They have questions regarding the success of in vitro fertilization and the possibility of having 2006; Holzer et al., 2006). When these are unsucces- twins or triplets. sful in inducing ovulation, (also refer- red to as ) may be used (Messinis, 2005). This is a much riskier strategy, with side eff- What is assisted reproduction? ects including ovarian hyperstimulation syndrome (Budev et al., 2005) and the creation of high-order Assisted reproduction enables the deliberate multiple pregnancies (Barrett and Bocking, 2000a, b). manipulation of the processes and materials of Provision of , by other than the woman’s human reproduction outside of sexual intercourse. partner, was one of the earliest forms of assisted In describing the practices that constitute assisted reproduction and has been encompassed in med- reproduction, it must be understood that all such ical practice for 50 years (Daniels et al., 2006). practices are embedded with ethical issues, whether is a common practice when a standard therapies such as ovulation induction woman’s partner has sperm of low count or quality (Messinis, 2005), with donor sperm or carries a communicable disease, when she is in a (Daniels et al., 2006), and in vitro fertilization (IVF) lesbian relationship, or if she is single. Oocytes may (Steptoe and Edwards, 1978); emerging practices be provided to women who no longer have an such as pre-implantation genetic diagnosis (PGD) ‘‘ovarian reserve,’’ because of their advanced age (Handyside, 1990; Nisker and Gore-Langton, 1995); (Pastor et al., 2005) or having undergone cancer or practices prohibited under law in many coun- treatment (Byrne et al., 1999; Nisker et al., 2006). tries, such as the purchase or bartering of oocytes ovarian stimulation create multiple (Gurmankin, 2001; Nisker, 1996, 1997, 2001). oocytes for IVF (Abramov et al., 1999). When the

An earlier version of this chapter has appeared: Shanner, L. and Nisker, J. (2001). Assisted reproductive technologies. CMAJ 164: 1589–1594.

112 Assisted reproduction 113

oocytes reach approximately 2 cm in diameter, they the gestational carrier, sperm other than that of the are matured with human chorionic man for whom the embryo/fetus is being gestated, and approximately 36 hours later are removed or both (Rodgers et al., 1997). through transvaginal ultrasonographic-guided nee- A relatively new area relates to the genetic dles (Yuzpe et al., 1989). The oocytes are placed in scrutiny of embryos by PGD (Handyside et al., Petri dishes under strict sterile conditions, sperm is 1990; Nisker and Gore-Langton, 1995), or most added, and if fertilization occurs, the embryos are recently, preimplantation genetic haplotyping (PGH) microscopically observed for two days (up to four (Renwick et al., 2006). The embryos or polar bodies days if the plan is to transfer blastocysts) (Blake et al., (Verlinsky et al., 1990) are assessed genetically 2002). Embryos are then transferred to the uterus through polymerase chain reaction (Mullis and (Min et al., 2006) (one or two embryos preferred, but Faloona, 1987) or fluorescent in situ hybridization often more in older women), and the remaining (Delhanty et al., 1993). Genetic determinations of embryos are cryopreserved for transfer in non- an embryo through PGD may be used not only to treatment cycles (Trounson and Mohr, 1983). Cryo- implant embryos to avoid a specific genetic char- preserved embryos no longer required for repro- acteristic but also to implant embryos with par- ductive purposes are usually donated to research ticular characteristics, for example embryos of a (Nisker and White, 2005) or discarded. They may, specific histocompatibility in a savior however, be donated to another couple, although scenario (Pennings et al., 2002), embryos that will this rarely occurs for a number of reasons, including result in a child who is deaf (Levy, 2002) or who has parental fear of allowing a child for another couple Duchene’s dwarfism (Nunes, 2006). that is genetically related to their own (Newton et al., 2003; Nachtigall et al., 2005). Pregnancy rates for IVF exceed 25% per cycle for women/couples whose Why is assisted reproduction important? etiology may be blocked Fallopian tubes, endometriosis, sperm problems (with intracyto- Assisted reproduction enables subfertile heterosex- plasmic sperm injection) (Van Steirteghem et al., ual couples, single women, and women in lesbian 1994) or unexplained. They become higher following relationships to have children. In addition, individ- the transfer of cryopreserved embryos (Alsalili et al., uals and couples who carry genetic conditions may 1995; Mishell, 2001). The risks of IVF are in both the wish to use assisted reproduction in order to avoid menotropin stimulation (Abramov et al.,1999; passing (or to deliberately pass) these conditions on Buckett et al., 2005) and the surgery (Alsalili et al., to their children. Thus, assisted reproduction is 1995). There are also risks to the child and family important for both medical and social indications. unit, such as those owing to multiple births (Barrett Assisted reproduction is increasingly important and Bocking, 2000a, b). as many women delay having a child until they Gestational agreements (Rodgers et al., 1997; Ber, have employment and financial security. Delay in 2000) are often used in conjunction with assisted becoming pregnant predisposes a woman not only reproduction practices (Mykitiuk and Wallrap, to deplete her ovarian reserve but also to develop 2002; Rivard and Hunter, 2005). Although the more other etiologies of infertility, such as endometriosis common type of gestational agreement occurs or tubal occlusion, as well as lengthening her when the gestational carrier is impregnated with exposure to environmental toxins (Younglai et al., the sperm of the partner of a woman who, because 2002), an under-researched area (Royal Commis- of medical problems, cannot gestate her own sion on New Reproductive Technologies, 1993). embryo/fetus, gestational agreements may also Assisted reproduction is also increasingly impor- include those in which the embryo’s genetic make- tant as more women are surviving cancer treat- up has resulted from an oocyte other than that of ment, including leukemias in girls and adolescents, 114 R. Mykitiuk and J. Nisker

lymphomas, and breast cancer (Nisker et al., 2006). Informed choice Women who have received chemotherapy, for Free and informed choice requires that the patient example, may have a dramatic decrease in the must be informed about the benefits and risks of number of ovarian Follicles that remain, and thus treatment, alternative courses of action, and the the normal attrition rate frequently causes these consequences of not having the treatment women to develop ovarian failure in their thirties (Mykitiuk and Wallrap, 2002). This includes the (Sklar et al., 2006). provision of sufficient information for the patient to be able to both understand and appreciate the Ethics chances of having a child for that particular patient Commercialization in that particular infertility clinic, including clarifi- cation of the meaning of success rates (as to bio- Commercialization and commodification of gam- chemical pregnancy or live birth), and the specific etes, and commercial gestational agreements, risks of treatment inherent for that patient (in gen- offend a number of ethical precepts including eral and in that particular clinic). Patients should respect for human integrity and dignity through the also be informed about the potential for multiple non-commodification and non-commercialization births to have physical and cognitive consequences of the person, her or his bodily parts, tissues, sub- for children, as well as social consequences for stances and processes; protection of vulnerable them and their families and financial costs (Barrett persons from coercion or inducement; and respect and Bocking, 2000a,b; Elster, 2000; Mykitiuk and for the patient–physician relationship by avoiding a Wallrap, 2002; Adamson and Baker, 2004). conflict of interest between the two parties (Royal A free choice process is difficult to ensure for sisters Commission on New Reproductive Technologies, and close friends of infertile women who have been 1993; Nisker and White, 2005). asked to become oocyte ‘‘donors’’ or gestational ‘‘Donation’’ is an ethically charged term in that, carriers for them (Rodgers et al., 1997; Ber, 2000). until the 1990s, in most countries, ‘‘donors’’ of sperm These women have indicated that they would feel and oocytes have been paid in the range of $100 for that they were a bad sister or a bad friend if they did sperm and between $1500 and $5000 for oocyte not comply with the request. Further, even in the donation (Nisker, 1996, 1997, 2001; Gurmankin, best-case scenarios for altruistic oocyte donation or 2001). In addition, oocyte ‘‘donors’’ are almost gestational agreements, ethical problems remain. always economically disadvantaged women who Informed choice is particularly difficult for those either sell their eggs to support their family or pay who are soon to undergo cancer treatment (Nisker tuition, or who barter half of their oocytes in order to et al., 2006). In the case of girls and adolescent undergo an IVF cycle (Royal Commission on New women, a substitute decision maker, usually a Reproductive Technologies, 1993; Nisker, 1996, 1997, or guardian, may base their decision on the 2001; Mykitiuk and Wallrap, 2002). The ethical belief that the child will want to be a mother. As problems of these practices is reflected in their pro- with adult women, decision making is also com- hibition by law in most Western European countries plicated by the fact that delaying cancer treatment such as France, the UK, and Germany, as well as in order to retrieve and cryopreserve oocytes (or for Australia, New Zealand, and Canada, amongst other adult women to possibly undergo IVF to freeze countries (see the list of relevant legislation at the end embryos) may be problematic to the success of the of the chapter). In some of these countries, sperm cancer treatment. Finally, although encouraging, donors may be offered reimbursement of expenses, the success of new techniques such as oocyte vit- and occasionally compensation for their time rification (Lucena et al., 2006) and in vitro matur- (Daniels et al., 2006). ation (Rao and Tan, 2005) requires further study. Assisted reproduction 115

Free and informed choice for research purposes These may include a woman’s or couple’s ability to may also be complex in that it is difficult for a parent, which may be perceived to be limited by woman undergoing fertility treatment not to agree physical or cognitive disability (Gurmankin et al., to a request by her physician to participate in 2005), low income (Gurmankin et al., 2005), marital research, as she may perceive that the research status (Vandervort, 2006), and sexual orientation must be important to the physician or it would not (Mykitiuk and Wallrap, 2002; Peterson, 2005). Indi- have been offered, and that a negative decision viduals and couples may also face barriers to access may compromise her clinical care (Sherwin, 1992, based on race and ethnicity (Mykitiuk and Wallrap, 1998; Kenny, 1994; Nisker and White, 2005). Par- 2002; Gurmankin et al., 2005). These non-medical ticularly regarding stem cell research, women who barriers to access are ethically suspect, often relying ‘‘volunteered’’ to undergo IVF to provide eggs may on discriminatory personal or social prejudices and be coerced (Cyranoski, 2004; Nisker and White, may be subject to human rights challenges (Mykitiuk 2005; Chang, 2006). and Wallrap, 2002).

Access Genetic determination

Access to assisted reproduction is constrained in Assisted reproduction is now used to determine the some jurisdictions by financial considerations and potential characteristics of children (Mykitiuk et al., other eligibility criteria. Without public funding, 2006) through PGD (Handyside et al., 1990; Nisker access to IVF is generally limited to economically and Gore-Langton, 1995) and PGH (Renwick et al., advantaged women/couples. In most countries 2006). Focus on genetic characteristics of an where a publicly funded healthcare system exists, embryo has been used not only to avoid a specific access to infertility treatment, including IVF and genetic characteristic but also to enhance the intracytoplasmic sperm injection, is provided. In chance a child will have a particular characteristic some countries, such as Australia, IVF is publicly (Pennings et al., 2002). To a limited degree, couples funded for the number of cycles it takes for the have for more than 10 years purchased sperm woman to complete her family, while in most from genius sperm banks and oocytes from ‘‘Ron’s Western European countries and Israel, some Angels’’ to enhance the chances of an ‘‘intelligent’’ restrictions are placed on the maximum number of or conventionally ‘‘beautiful’’ child (Nisker and cycles or the maximum number of children for Gore-Langton, 1995; Nisker, 2002). The use of these which publicly funded IVF is available (Birenbaum- strategies, as well as PGD and PGH for such pur- Carmeli, 2004). Canada is an exception among poses, raises ethical issues about the proper use of countries with publicly funded healthcare systems medical technology and the physician’s role in in that no public funding is provided for IVF and providing enhancement rather than therapeutic corollary therapies, with the exception of the prov- benefits (Nisker, 2002). The use of PGD to avoid ince of Ontario, where IVF is provided for blocked specific genetic conditions and diseases is also Fallopian tubes only (Mykitiuk and Wallrap, 2002; considered by some to be ethically problematic, Nisker, 2004). resting on discriminatory ideas of disability and Access may also be restricted by the eligibility cri- difference (Parens and Asch, 1999; Shakespeare, teria used by physicians and clinics. Although the 1999; Taylor and Mykitiuk, 2001; Mykitiuk, 2002a). access criteria typically center on the potential Also morally complex is the use of PGD to detect benefits and risks to the health and safety of partici- embryos of a specific histocompatibility in order to pants based on medical factors, including the con- produce a savior sibling for an existing child dition of infertility and the participant’s age, some (Pennings et al., 2002). The potential use of PGD to physicians and clinics use non-medical criteria. ascertain embryos that will result in a child who is 116 R. Mykitiuk and J. Nisker

deaf (Levy, 2002) or who has Duchene’s dwarfism body whose responsibility it is to license, inspect, (Nunes, 2006) is also ethically problematic. and monitor all human reproduction clinics. Further, domestic human rights legislation may prohibit Social factors discrimination: for example, a single or disabled woman, or lesbian couple being denied access to Assisted reproduction also makes possible the IVF or donor conception for non-medical reasons. creation of novel social arrangements: postmortem In most countries where legislation regarding insemination, virgin births, postmenopausal preg- assisted reproduction exists, it is illegal to create nancy, multiple , anonymous genetic par- an embryo for research purposes (e.g., Canada, ents, and embryos conceived at one time being born France, Germany, and ; see legislation at at different times or to different people (Mykitiuk, the end of this chapter). By contrast, in the UK, it 2002b). The use of assisted reproduction, therefore, is legal to create an embryo for research if legal has implications for kinship and also the under- consent has been given, provided one is licensed to standing of the legal, social, and emotional bonds do so (Human Fertilization and Embryology Act, created by heredity and the consequences pre- 1990). However, in some countries, such as Canada, sumed to ensue from processes of conception and France, and Australia, research can be performed birth (Mykitiuk, 2002b). Social factors include the on embryos that were created for reproductive inappropriate continuation of a male-dominant purposes but are no longer required for this pur- work ethic that sees women as less valuable pose, pursuant to a license and with consent of the employees if they want to become pregnant. This embryo donor. In most countries with legislation, coerces women to delay pregnancy and risk infer- there are also prohibitions on reproductive cloning, tility rather than create an obstacle to career ectogenesis, and germ-line modification. For more advancement or employment. on issues related to stem cell research and thera- Law and policy peutic cloning, see Chs. 21 and 31. Professional practice policies are developed in Western European countries, such as France, order to set the standard of care by which clinicians Sweden, the UK, and Germany, as well as Australia, should practice in order to provide optimal thera- New Zealand, Canada, and Israel, have enacted peutic outcome and minimum risk to their legislation governing assisted reproduction (see the patients. As policies impact not only patients, legislation listed at the end of this chapter). How- clinicians, and researchers but also social rela- ever, in many jurisdictions, including the USA and tionships and institutions, good policy making eastern Europe, these practices remain largely must involve voices and perspectives of all parties unregulated by law. ‘‘Reproductive tourism’’ can who are affected by that policy, as well as those of result when patients and clinicians are prohibited the general public. In the development of such by law from accessing certain practices in their policies, it should be appreciated that women more own jurisdiction (Storrow, 2005). than men are affected by assisted reproductive The law generally sets out prohibited practices, practices (Royal Commission on New Reproductive usually enforceable through criminal sanctions Technologies, 1993). (e.g., payment for gestational arrangements and oocytes in most jurisdictions) and provides a regulatory framework within which permissible How should I approach assisted practices must be carried out (e.g., the storage, reproduction in practice? handling, and use of reproductive materials, and a registry of gamete donors). In addition, national Understanding that assisted reproduction is an legislation may establish a regulatory or oversight ethically complex area of medicine, whether the Assisted reproduction 117

clinician is a family physician, general gynecologist, in the informed choice process. The fact that Ms. F fertility specialist, nurse, social worker, or psycho- is 38 years of age may allow ethical practice to logist, is essential in its practice. Family physicians commence infertility investigation if after one year and general gynecologists may become skilled in pregnancy does not occur (or slightly before many aspects of infertility investigation, including because of irregular ovulation, as with Ms. F), as well history taking, physical examination, assessment of as permitting the transfer of more than one or two and ovulation characteristics, tubal patency, embryos during the treatment cycle. This couple as well as parameters of general health. As referring should be made aware in the informed choice pro- physicians, these individuals should be aware of the cess that their chance of having a child, biologically infertility clinics that provide optimal care. Infertility related to them, through assisted reproduction or specialists have the obligation to be educated in all otherwise is much lower than the overall statistics currently clinically proven investigations and treat- reported by infertility clinics. Further, the additional ments. These specialists have an obligation to keep risk of multiple pregnancy, and the physical and accurate records and report their findings in a cognitive risks to the child inherent in multiple manner in which the pregnancy and treatment- births, need to be addressed, as the option of more complication rates are clearly apparent to patients than two embryos being transferred will likely be and referring physicians. All clinicians have the offered. Ms. F and Mr. G, as all women/couples in obligation to provide a free and comprehensive their age group (and indeed all women/couples), informed choice process. should be counseled about the possibility of adop- Clinicians need to be mindful of the fact that that tion, and about the fact that in most ‘‘developed’’ there may be both national and state/territorial/ countries, access to an infant through adoption is provincial legislation governing assisted human very limited, and access to international adoption reproductive practices. Access to appropriate infer- is restricted to the financially well off. tility treatment is problematic in countries such as Canada and the USA where, unlike Western European countries, Australia, and Israel, IVF is not REFERENCES covered under a publicly funded healthcare system, and advocacy for socioeconomically disadvantaged Abramov, Y., Elchalal, U., and Schenker, J. G. (1999). patients is required. Professional practice guidelines Severe OHSS: an ‘‘epidemic’’ of severe OHSS: a price should be developed in order to have uniform we have to pay? Hum Reprod 14: 2181–3. reporting of data and to advise both fertility spe- Adamson, D. and Baker, V. (2004). Multiple births from cialists and referring physicians as to the standards assisted reproductive technologies: a challenge that of care. must be met. Fertil Steril 81: 517–22. Alsalili, M., Yuzpe, A., Tummon, I., et al. (1995). Cumula- tive pregnancy rates and pregnancy outcome after The case in-vitro fertilization: 5000 cycles at one centre. Hum Reprod 10: 470–4. The ethical issues embedded in the case include Barrett, J. and Bocking, A. (2000a). The SOGC Consensus Statement: Management of Twin Pregnancies Part 1. the inability of some women/couples, because of Soc Obstet Gynaecol Canada 22: 619–29. their financial or social situation, to access assisted Barrett, J. and Bocking, A. (2000b). The SOGC Consensus reproduction and the informed choice process, Statement: Management of Twin Pregnancies Part 2. particularly considering clinical factors (e.g., age of Soc Obstet Gynaecol Canada 22: 607–10. the woman) that may allow for more risky treat- Ber, R. (2000). Ethical issues in gestational . ment strategies and require different information Theor Med 21: 153–69. 118 R. Mykitiuk and J. Nisker

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