Creating and selling embryos for “donation”: ethical challenges

The commercial creation and sale of embryos has begun, which poses a series of ethical questions that have received little scholarly attention. Some of the concerns that arise are similar to those posed by the sale of gametes, while other issues differ markedly. Questions emerge, first, regarding the rights of the unborn children and their ability to know their biological parents. Companies that create human embryos de novo may wish to keep gamete providers anonymous. Many of these offspring thus will never learn that their parents are not their biologic parents. Yet, such disclosures, regarding not only one but both of these biologic parents, may be important for these individuals; and a lack of this knowledge may impede their physical and psychological health. Second, questions surface regarding the fees that providers should charge for embryos and whether these amounts should vary based on the traits of 1 or both of the gamete donors. Some prospective parents may seek specific traits in a baby (eg, height or eye/hair coloring), which prompts the creation of embryos from 2 gamete donors who possess these characteristics. Third, ownership of embryos created without an advanced directive by patients poses dilemmas (eg, disposition of any remaining embryos). Fourth, guidelines do not yet exist to limit the number of embryos sold from each pair of gamete donors. Hence, unbeknownst to each other, full siblings could potentially meet, get married, and procreate. This discussion has several critical implications for future practice and professional education and policy. Patients with diseases associated with genetic tests may well ask obstetricians, gynecologists, and other physicians about these techniques and practices. Clinicians can refer such patients to assisted reproductive technology specialists; however, familiarity with the basic aspects of the issues and complexities involved could aid these providers and their patients Several of these issues can be addressed relatively easily through guidelines from professional associations (eg, limiting the number of embryos sold from each pair of gamete donors). Because creation and sales of embryos will likely spread, consideration of appropriate responses is critical to establish standards of care to help the future offspring, and ensure ongoing public trust

Oocyte donation: reflections on past work and future directions

Accomplishments in the field of oocyte donation may soon be overshadowed by increasingly questionable practices

Controversies concerning mitochondrial replacement therapy

Research on mitochondrial replacement therapy (MRT) holds the promise of helping women who have, or are at risk of transmitting, mitochondrial disease, but has recently been blocked by the Food and Drug Administration (FDA). Thus, several critical ethical and policy questions arise. Mitochondrial disease can be devastating for those who have it. Yet existing treatments remain supportive rather than curative. Women confronting this disease have a high chance of having an affected child and limited reproductive alternatives

Kamakahi vs ASRM and the future of compensation for human eggs

A recent lawsuit that alleges that the American Society for Reproductive Medicine (ASRM) engages in price-fixing by capping the amount of compensation paid for human oocytes has several critical ethical and policy implications that have received relatively little attention. ASRM has argued that ceilings on donor compensation prevent enticement, exploitation, and oocyte commodification. Critics counter that low donor compensation decreases supply, because fewer women are then interested in donating, which then increases prices for the service that physicians, not donors, accrue, and that ethical goals can be better achieved through enhanced informed consent, hiring egg donor advocates, and better counseling and screening. Yet, if compensation caps are removed, questions emerge concerning what the oocyte market would then look like. Informed consent is an imperfect process. Beyond the legal and economic questions of whether ASRM violates the Sherman Anti-trust Act also lie crucial questions of whether human eggs should be viewed as other products. We argue that human eggs differ from other factory-produced goods and should command moral respect. Although eggs (or embryos) are not equivalent to human beings, they deserve special consideration, because of their potential for human life, and thus have a different moral status. ASRM’s current guidelines appear to address, even if imperfectly, ethical challenges that are related to egg procurement for infertility treatment. Given public concerns about oocyte commodification and ASRM’s wariness of government regulations, existing guidelines may represent a compromise by aiding patients who seek eggs, while simultaneously trying to avoid undue influence, exploitation, and eugenics. Although the ultimate outcome of this lawsuit remains unclear, policy makers, providers, lawyers, judges, and others should attend seriously to these issues. Alternatives to current ASRM guidelines may be possible (eg, raising the current caps to, say, $12,000 or$15,000, potentially increasing donation, while still avoiding certain ethical difficulties) and warrant close consideration. These complex conflicting ethical issues deserve more attention than they have received because they affect key aspects of clinical practice and the lives of countless patients

A combination of norethindrone acetate and leuprolide acetate blocks the gonadotrophin-releasing hormone agonistic response and minimizes cyst formation during ovarian stimulation

A protocol utilizing both leuprolide acetate (LA) and norethindrone acetate (NETA) in subjects undergoing ovarian suppression prior to follicle aspiration proved more effective than LA alone in reducing the incidence of ovarian cyst formation without affecting clinical outcome. Patients (n = 105) undergoing ovarian stimulation followed by follicle aspiration and in-vitro fertilization (IVF) were prospectively randomized and studied. Study measures included ovarian suppression days, days of human meno-pausal gonadotrophin (HMG) stimulation, serum oestradiol concentrations, number of cycles developing de novo cysts (> 15 mm), number of induced flare responses (day 8 oestradiol 5=50 pg/ml), number of office visits, total dose exogenous gonadotrophins, number oocytes retrieved, and clinical pregnancy and delivery rates per retrieval. Patients undergoing FVF received either LA alone (n = 58; controls) or LA and NETA (n = 47; study group) for the first 8 days of their cycle. Results comparing NETA/LA versus LA demonstrated: serum oestradiol 20.7 ± 3.9 versus 573 ± 9.4 pg/ml respectively on day 8 of ovarian suppression (P 15 mm compared to 15 (25.9%) controls (P < 0.01). No differences were observed for days of stimulation, peak oestradiol attained, total dosage of exogenous gonadotrophins, or number of aspirated oocytes. Neither were there differences in the clinical pregnancy (26.8 versus 22.6%) nor in delivery rates (19.5 versus 20.8%). We conclude that the addition of NETA to LA enhances ovarian suppression and lessens ovarian cyst formation, thereby significantly decreasing the overall cost per cycle

Addressing the Fertility Needs of HIV-Seropositive Males

An increasing number of serodiscordant couples are utilizing advanced reproductive technologies to address their reproductive needs. Recent literature has demonstrated that it is not only technically possible but also safe to utilize sperm-washing techniques to allow for the creation of embryos, thereby preventing both horizontal and vertical transmission of HIV. This article addresses the strengths and weakness of various reproductive techniques and discusses our experience at Columbia University (NY, USA), the location of the largest HIV-focused fertility program in the USA

Payment of egg donors in stem cell research in the USA

Arguments have been put forth as to whether women who donate oocytes for human embryonic stem cell (HESC) research should be compensated, but data regarding this issue have been scant. Recently in the United States, several States have begun funding HESC research, and patient recruitment efforts have begun. This paper lays out relevant arguments and presents data concerning this issue. Researchers are finding that women are unwilling to donate eggs altruistically, which is hampering the progress of research. These efforts are examined, and data on potential donors’ views are presented. The absence of payment, rather than ethical concerns, appears to explain opposition to donation. Women also appear generally ignorant of policies in this area. It is suggested that policy discussions shift focus from whether to pay, to how much would be appropriate, and how to decide; and that research and public and professional education be increased to heighten understanding and awareness of these issues

Pregnancy Following Hysteroscopic Resection of a Leiomyoma and Oocyte Donation

A successful pregnancy was established in a functionally agonadal woman using oocyte donation following resection of a large leiomyoma. The patient had a 6 × 6 cm intramural tumor with intracavitary extension. She was symptomatic with metrorrhagia. A conservative approach was undertaken in an attempt to restore normal endometrial anatomy. Hysteroscopic resection removed a 3 × 3 × 2 cm mass. Postoperatively, hysteroscopy was normal, and oocyte donation was performed. Implantation occurred, and a living, 3600 g female infant was delivered vaginally at 40 weeks gestation without complication. This case illustrates an approach to managing cavity-distorting leiomyomas in perimenopausal women interested in oocyte donation. When hysteroscopic resection of leiomyomas is successful, major surgery is avoided, and pregnancy, labor, and delivery may proceed normally

Anticipating issues related to increasing preimplantation genetic diagnosis use: a research agenda

Increasing use of preimplantation genetic diagnosis (PGD) poses numerous clinical, social, psychological, ethical, legal and policy dilemmas, many of which have received little attention. Patients and providers are now considering and using PGD for a widening array of genetic disorders, and patients may increasingly seek ‘designer babies.’ In the USA, although governmental oversight policies have been discussed, few specific guidelines exist. Hence, increasingly, patients and providers will face challenging ethical and policy questions of when and for whom to use PGD, and how it should be financed. These issues should be better clarified and addressed through collection of data concerning the current use of PGD in the USA, including factors involved in decision making about PGD use, as well as the education of the various communities that are, and should be, involved in its implementation. Improved understanding of these issues will ultimately enhance the development and implementation of future clinical guidelines and policies