Public attitudes towards novel reproductive technologies: a citizens' jury on mitochondrial donation.

STUDY QUESTION: Does an informed group of citizens endorse the clinical use of mitochondrial donation in a country where this is not currently permitted? SUMMARY ANSWER: After hearing balanced expert evidence and having opportunity for deliberation, a majority (11/14) of participants in a citizens' jury believed that children should be able to be born using mitochondrial donation. WHAT IS KNOWN ALREADY: Research suggests that patients, oocyte donors and health professionals support mitochondrial donation to prevent transmission of mitochondrial disease. Less is known about public acceptability of this novel reproductive technology, especially from evidence using deliberative methods. STUDY DESIGN, SIZE, DURATION: This study comprised a citizens' jury, an established method for determining the views of a well-informed group of community members. The jury had 14 participants, and ran over one and a half days in 2017. PARTICIPANTS/MATERIALS, SETTING, METHODS: Jurors were members of the public with no experience of mitochondrial disease. They heard and engaged with relevant evidence and were asked to answer the question: 'Should Australia allow children to be born following mitochondrial donation?' MAIN RESULTS AND THE ROLE OF CHANCE: Eleven jurors decided that Australia should allow children to be born following mitochondrial donation; 7 of whom added conditions such as the need to limit who can access the intervention. Three jurors decided that children should not (or not yet) be born using this intervention. All jurors were particularly interested in the reliability of evidence, licensing/regulatory mechanisms and the rights of children to access information about their oocyte donors. LIMITATIONS, REASONS FOR CAUTION: Jurors' views were well informed and reflected critical deliberation and discussion, but are not intended to be representative of the whole population. WIDER IMPLICATIONS OF THE FINDINGS: When presented with high quality evidence, combined with opportunities to undertake structured deliberation of novel reproductive technologies, members of the public are able to engage in detailed discussions. This is the first study to use an established deliberative method to gauge public views towards mitochondrial donation. STUDY FUNDING/COMPETING INTEREST(S): This study was funded by a University of Sydney Industry and Community Collaboration Seed Award (2017), which was awarded contingent on additional funding from the Mito Foundation. Additional funding was provided by the Mito Foundation. The Foundation was not involved in jury facilitation or deliberation, nor analysis of research data. TRIAL REGISTRATION NUMBER: Not applicable.

Legal principles and seminal legal cases in oocyte donation.

Oocyte donation has played an increasingly important role in assisted reproductive technologies since the early 1980s. Over the past 30 years, unique legal standards have evolved to address issues in the oocyte donation procedure itself as well as the disputes over issues, such as parentage, that inevitably arise with new technologies, particularly for individuals seeking to build nontraditional families. This essay will explore oocyte donation's legal aspects as well as seminal law concerning the procedure, including statutory law (uniform and model provisions and enacted state laws) and selected judicial opinions concerning surrogacy and parentage, testing of oocyte donors, mix-ups of donated oocytes, and donor compensation.

Innovations in assisted reproductive technologies: impact on contemporary donor egg practice and future advances.

Innovations in assisted reproductive technologies (ART) have driven progress in the donor egg field since the birth of the first baby derived from a donor egg in 1983. Over time, donor oocytes have become an increasingly used option for patients unable to conceive with autologous oocytes. In donor egg, the unique separation of the oocyte source and recipient uterus has created a model that has propelled advances in ART. Progressive ART innovations that have optimized the oocyte donor and resulting embryo include the following: evaluation of ovarian reserve, controlled ovarian hyperstimulation regimens that reduce the risk of ovarian hyperstimulation syndrome, blastocyst culture, oocyte cryopreservation, and preimplantation genetic testing. For donor egg recipients, methods to optimize the endometrium to maximize implantation include endometrial receptivity testing, immunologic donor-recipient matching, and increased understanding of the uterine microbiome.

Euploid embryos selected by an automated time-lapse system have superior SET outcomes than selected solely by conventional morphology assessment.

PURPOSE: We investigated if automated TLI selection may be a valuable strategy to identify those euploid embryos with the best chances of success. METHODS: This is a unicentric and retrospective study involving 244 patients undergoing preimplantational genetic screening (PGS) cycles with autologous oocytes or oocyte donation (OD) with single euploid embryo transferred. We examined euploid embryos selected for transfer based on morphology evaluation alone (PGS-only; control group) or by assessment using an automated TLI system (Eeva™; PGS-TLI group). RESULTS: In both, autologous oocytes and OD patients, significantly better implantation and clinical and ongoing pregnancy rates were obtained in the PGS-TLI group when euploid embryos with high implantation potential as predicted by the automated TLI System (Eeva™) were transferred compared with the PGS-only group. This improvement was also observed when only transfers of good morphological quality embryos were compared. TLI categories showed significant differences on blastocyst formation and euploidy rate. CONCLUSIONS: Automated TLI combined with PGS is a useful prognostic tool to identify euploid embryos with the highest potential for implantation and pregnancy. Further, these results provide evidence that a healthy pregnancy does not only depend upon normal chromosomal status.

Donor motivations, associated risks and ethical considerations of oocyte donation.

Three decades after the first reported successful cases, oocyte donation continues to grow in popularity and regard as an established method to aid women in achieving their reproductive goals. As a result of the increased demand for donated oocytes, many young women in the U.S. volunteer to undergo complex medical procedures to donate their oocytes in return for financial compensation. To best care for these women before, during and after donation, it is important to explore donor characteristics and motivations, discuss the safety of the donation procedure and examine the ethical issues related to this process.

Egg donation for stem cell research: ideas of surplus and deficit in Australian IVF patients' and reproductive donors' accounts.

We report on a study undertaken with an Australian in vitro fertilisation (IVF) clinic to understand IVF patients' and reproductive donors' perceptions of oocyte (egg) donation for stem cell research. Such perspectives are particularly valuable because IVF patients form a major recruitment group for oocyte donation for research, and because patients and donors have direct experience of the medical procedures involved. Similar studies of oocyte donation have been carried out elsewhere in the world, but to date very little social science research has been published that reports on donation for research, as distinct from donation for reproduction. Our respondents expressed a distinct unwillingness to donate viable oocytes for stem cell research. In our analysis we consider a number of factors that explain this unwillingness. These include the labour of oocyte production, the inscrutability of oocytes (the lack of a test to identify degrees of fertility) and the extent to which the oocytes' fertility sets the parameters for all downstream reproductive possibilities. We draw on the science studies literature on affordances to make sense of the social intractability of oocytes, and compare them with the respondents' much greater willingness to donate frozen embryos for human embryonic stem cells research.

Reverse traffic: intersecting inequalities in human egg donation.

The paper examines a case of cross-border reproductive care that happens in reverse by looking at Israeli--Romanian transnational ova traffic. The state of Israel claims to have the most IVF clinics per capita in the world, some of the highest success rates in the use of assisted reproductive technology, very liberal regulation of these technologies and the most heavily subsidized IVF in the world. This support and the government's demographic policies are designed to encourage the growth of the Jewish population in its demographic race against Palestinians. Yet transnational egg donation is very costly and reimbursement to patients a slow and involved process. Hence, while transnational ova donation is increasing in Israel, only a few can afford to participate in this border crossing. Further, new laws are meant to forbid cross-religious donation in Israel, hardening the borders of the Jewish State. Romanian ova donors are part of the global majority, exploited by markets' incursions into new niches in bodies. The history of Romanian oppression of women's reproduction makes today's women willing to undergo invasive treatment for very little compensation, even when there is the possibility of injury. This paper documents reverse traffic reproduction, which maintains, rather than addresses, inequalities.

Ethics in egg donation: past, present, and future.

Since the advent of clinical human egg donation just over 25 years ago, ethical considerations have been central to its successful application and popular acceptance. Early in its history, "essentialist" arguments questioning the moral validity of the practice altogether were commonplace. More recently, most academic discussion has been focused on "consequentialist" issues relating to practical approaches to egg donation that minimize ethically troublesome consequences. Three issues that have attracted a bulk of the attention in this regard are compensation, postmenopausal pregnancy, and egg sharing. Although much consensus has been reached on some very controversial issues, the enormous potential of increasingly successful oocyte cryopreservation, as well as emerging stem cell technologies, is very likely to provide abundant fuel for the continued debate of provocative and contentious ethical issues in human egg donation.

Sharing motherhood: biological lesbian co-mothers, a new IVF indication.

BACKGROUND: We herein present the initial experiences of the CEFER Institute of Reproduction in the formation of a new family model: two biological mothers, lesbians, one who provides the eggs and the other who carries the embryo in her womb. We have called this family model ROPA (Reception of Oocytes from PArtner). It is a pioneer event in Spain and among the first at a worldwide level. METHODS AND RESULTS: Fourteen lesbian couples have undergone treatment using the ROPA technique. This paper briefly describes the technique. Six pregnancies have been obtained from 13 embryo transfers. There were two miscarriages and there are three ongoing pregnancies, one of them twins. One healthy female baby was born. The following aspects are addressed: (i) legal status of lesbian couples in Western countries; (ii) the lesbian couple's access to assisted reproduction techniques; (iii) ethical aspects; (iv) medical acceptability; and (v) single mother versus lesbian mothers. CONCLUSIONS: In countries where the ROPA technique is legal, it offers lesbian couples a more favourable route, involving both partners, to start a family, and doctors who treat lesbian couples must be sensitive to this new family model.

Racial disparity in oocyte donation outcome: a multiethnic, matched cohort study.

BACKGROUND: Race and ethnicity are one of the newly investigated patient-related prognostic factors that might affect the outcome of assisted reproduction techniques. To our knowledge no data currently are available on the effect of race on oocyte donation outcome. MATERIALS: A retrospective, matched cohort study was performed in a private infertility centre evaluating 1012 Black, South-East Asian and Caucasian recipients undergoing their first oocyte donation cycles. RESULTS: A significantly lower ongoing pregnancy rate (24.6 versus 36.8%, OR: 0.56 95% CI: 0.40-0.77, P = 0.01) was observed among Black recipients compared with their matched Caucasian counterparts. The prevalence of uterine fibroids (49.6 versus 17.1%, P < 0.0001) and previous history of tubal infertility (53.2 versus 16.5%, P < 0.0001) was significantly higher among Black women. Multiple logistic regression analysis showed that, after adjusting for confounding variables, Black race was an independent risk factor for not achieving an ongoing pregnancy (for ongoing pregnancy, adjusted OR: 0.62 95% CI: 0.43-0.89, P = 0.009). Ongoing pregnancy rate (37.2 versus 37.2%, OR: 1.0 95% CI: 0.49-2.04, P = 1.0) was not significantly different between South-East Asian and matched Caucasian patients. CONCLUSIONS: Black race was an independent risk factor for not achieving an ongoing pregnancy after oocyte donation. Although yellow race does not seem to adversely affect oocyte donation, larger studies are still warranted to draw more solid conclusions. Race should be considered as an independent prognostic factor in oocyte donation.

A prospective, randomized, controlled trial comparing three different gonadotropin regimens in oocyte donors: ovarian response, in vitro fertilization outcome, and analysis of cost minimization.

OBJECTIVE: To compare the efficacy of three different gonadotropin regimens in an oocyte donation program. The analysis of cost minimization also was evaluated. DESIGN: Prospective, randomized, controlled study. SETTING: Instituto Universitario-IVI, Valencia, Spain. PATIENT(S): One thousand twenty-eight donors undergoing a GnRH agonist protocol were assigned randomly to one of three groups: group 1 (n=346), only recombinant FSH (rFSH); group 2 (n=333), only highly purified menotropin (HP-hMG); and group 3 (n=349), rFSH plus HP-hMG. One thousand seventy-nine oocyte recipients. INTERVENTION(S): Controlled ovarian stimulation. MAIN OUTCOME MEASURE(S): Controlled ovarian stimulation parameters, IVF outcome, and cost analysis. RESULT(S): No differences were found among the groups with respect to days of stimulation, gonadotropin dose, final E2 and P levels, number of oocytes retrieved, and cancellation rate. Similarly, there were no differences among the groups in terms of embryo development parameters. Moreover, implantation, pregnancy, and miscarriage rates with the three regimens were similar. However, the cost of rFSH was greater than that of the other protocols. CONCLUSION(S): This study suggests that in the GnRH agonist protocol the three different gonadotropin regimens evaluated herein are equally effective. Protocols using HP-hMG would appear to be the best in terms of cost-effectiveness in an oocyte donation program.

Egg freezing, procreative liberty, and ICSI: the double standards confronting elective self-donation of oocytes.

The consensus view among relevant professional societies opposing the offering of elective oocyte cryopreservation for potential future self-donation withstands neither clinical nor ethical scrutiny. The favorable risk-benefit ratio of this technology mandates both the prioritization of patient autonomy for informed women seeking to maximize-not guarantee-their chances of having genetically related children, and a justification for viewing egg freezing differently from intracytoplasmic sperm injection.

ASRM Practice Committee response to Rybak and Lieman: elective self-donation of oocytes.

Oocyte cryopreservation has great promise for applications in oocyte donation and fertility preservation and for decreasing the number of unused cryopreserved embryos. The Practice Committee has and will continue to review the published medical literature relating to oocyte cryopreservation at regular intervals and is prepared to reconsider its position when evidence warrants.

Practice of sharing donated oocytes among several recipients.

Sharing donated oocytes among several recipients is an effective practice. It lowers the cost, shortens their waiting time, and offers a satisfactory pregnancy rate.

Ethical issues in transnational "mail order" oocyte donation.

The rising demand for donor oocytes in developed countries has led to what is referred to as transnational or international oocyte donation, or the outsourcing of oocyte donation to poorer countries. In a further twist, frozen sperm from a recipient's partner can also be mailed to a foreign clinic to fertilize donor oocytes, and the resulting embryos are mailed back, cryopreserved, for transfer to the recipient. Among the numerous ethical concerns raised by this practice of mail order oocyte donation, the most obvious are that underprivileged women from poorer countries are often exploited; fertility physicians from richer counties abdicate responsibility for the welfare of donors; and responsibility could become an issue of contention if transmission of disease to the oocyte recipient or congenital defects in offspring born from such oocyte donation were to occur. Moreover, savings from utilizing donors from poorer countries ought to be shared with oocyte recipients.

The egg-sharing model for human therapeutic cloning research: managing donor selection criteria, the proportion of shared oocytes allocated to research, and amount of financial subsidy given to the donor.

Recent advances in human therapeutic cloning made by Hwang and colleagues have opened up new avenues of therapy for various human diseases. However, the major bottleneck of this new technology is the severe shortage of human donor oocytes. Egg-sharing in return for subsidized fertility treatment has been suggested as an ethically justifiable and practical solution to overcome the shortage of donor oocytes for therapeutic cloning. Because the utilization of shared oocytes in therapeutic cloning research does not result in any therapeutic benefit to a second party, this would necessitate a different management strategy compared to their use for the assisted conception of infertile women who are unable to produce any oocytes of their own. It is proposed that the pool of prospective egg-sharers in therapeutic cloning research be limited only to younger women (below 30 years of age) with indications for either male partner sub-fertility or tubal blockage. With regards to the proportion of the shared gametes being allocated to research, a threshold number of retrieved oocytes should be set that if not exceeded, would result in the patient being automatically removed from the egg-sharing scheme. Any excess supernumerary oocyte above this threshold number can be contributed to science, and allocation should be done in a randomized manner. Perhaps, a total of 10 retrieved oocytes from the patient may be considered a suitable threshold, since the chances of conception are unlikely to be impaired. With regards to the amount of subsidy being given to the patient, it is suggested that the proportion of financial subsidy should be equal to the proportion of the patient's oocytes being allocated to research. No doubt, the promise of future therapeutic benefit may be offered to the patient instead of financial subsidy. However, this is ethically controversial because therapeutic cloning has not yet been demonstrated to be a viable model of clinical therapy and any promises made to the patient might turn out to be illusionary. Hence, it is proposed that a tangible financial subsidy on the medical fees might be the better option for the patient's welfare.