What can be learned from the Chinese experience in response to infertility.

OBJECTIVES: The aims of the study were to reviews the history of China's population policy since 2011, and draw lessons from the Chinese experience in response to infertility. METHODS: Data from the Chinese infertility status survey report (2009) and national statistical yearbooks (2009-2019) are used to assess the severity of infertility and reproductive centers shortage in China. Lessons from China was informed by a review of existing literature. RESULTS: The proportion of couples suffering from infertility in China increased to 12.5% (166.8 million in 2009) from just 6.89% (86.6 million in 1988) two decades earlier, while the number of reproductive centers was one for every 3.1 million citizens. The total costs per live birth for medically assisted reproduction in Chinese public fertility clinics was 30,000 yuan in 2012. Among infertile couples, unemployed patients accounted for the largest proportion (21.9% in 2014). Currently in China, health regulations permit oocyte donation only from infertility patients who have 20 or more mature oocytes, of which at least 15 must be kept for their own treatment. CONCLUSION: It is necessary to integrate the reproductive health care of infertile people into the national public health service. In addition to relieving their economic burden, national policies should guide and support enterprises to guarantee employee medical leave for infertility. Growing numbers of bereaved older women who have lost their only child make it imperative to reconsider liberalizing the regulation of oocyte donation in China.

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.

Attitudes of anonymous and identity-release oocyte donors towards future contact with donor offspring.

STUDY QUESTION: What are the attitudes and expectations of past oocyte donors concerning contact with their donor offspring and contact between donor offspring and their own children? SUMMARY ANSWER: The large majority (95%) of open-identity oocyte donors, as well as voluntarily registered donors (registered before the Finnish 2007 ART law), expressed positive or neutral feelings towards contact with their donor offspring and mainly positive expectations towards contact between donor offspring and their own children. WHAT IS KNOWN ALREADY: Although there is a growing support for openness and identity-release programmes in gamete donation, there is not much knowledge on how donors feel about potential contact with their offspring. Most previous studies have investigated donor expectations with a relatively short follow-up time, using small samples or participants in voluntary donor linkage services. STUDY DESIGN, SIZE, DURATION: A retrospective cross-sectional survey of all women who had donated oocytes between 1990 and 2012 at three fertility clinics in Finland was carried out in 2013. A self-administered questionnaire was sent out to a total of 569 former oocyte donors. PARTICIPANTS/MATERIALS, SETTING, METHODS: In total, 428 former oocyte donors answered a questionnaire assessing experiences and attitudes related to donation (response rate 75.2%). In this study, 358 donors who were unknown to the recipient were included. The mean follow-up time after the donation was 11.2 years. Before 2008, donors were non-identifiable but could voluntarily consent to release their identifying information to their donor offspring. After 2008, persons born as a result of gamete donation can, from the age of 18, receive information identifying the donor. Altogether 290 respondents had participated in a donation programme in 1990-2007 (before the Finnish ART-law), and 68 participated after the enactment of the ART-law, enabling us to compare attitudes by type of legislation during donation. MAIN RESULTS AND THE ROLE OF CHANCE: Most voluntarily registered and open-identity donors welcomed or were neutral to potential contact with their donor offspring but were slightly more cautious towards contact between their own children and a donor-conceived child. Open-end comments revealed some ambiguity and uncertainty as to what to expect from such contact and feelings varied from neutral curiosity and interest to desire to meet the donor-conceived child. LIMITATIONS, REASON FOR CAUTION: It is not possible to assess whether the opinions of the study participants is representative of all donors in 1990-2012, as 25% of all contacted former donors did not respond to the survey. WIDER IMPLICATIONS OF THE FINDINGS: This study is one of only a few studies among oocyte donors to evaluate long-term psychosocial consequences of the donation and expectations towards contact with donor offspring, using a large sample. Results from this study show that persisting concerns about adverse outcomes of identity release policies are largely unwarranted, but there is a need to develop counselling practices and material for identity-release donors about how to prepare for and adjust to potential contact with donor offspring. STUDY FUNDING/COMPETING INTEREST(S): This study was supported by grants from the Medical Society Life and Health, and from the Otto A. Malm Foundation. The authors have no competing interests to report. TRIAL REGISTRATION NUMBER: N/A.

[Regulación de la donación de gametos y embriones en las técnicas de reproducción humana asistida: ¿anónima o abierta?]

The use of donated gametes and embryos in assisted reproduction techniques (ART) makes it necessary to examine interests that involve relevant ethical and legal considerations, which include the autonomy and privacy rights of the intended parents, donors' right to privacy and the right of the minors to know their genetic origin. This article presents arguments to consider policies of more openness to obtain information from donors in order to protect the child's best interest in knowing his/her genetic origins. It concludes with the situation in Mexico, where ART has been carried out with donated gametes since several years ago; however, due to the absence of regulations to control these procedures, each establishment imposes its own criteria for the operation of its programs.

El uso de gametos y embriones donados en técnicas de reproducción humana asistida hace necesario examinar intereses que implican consideraciones éticas y jurídicas relevantes, y estos incluyen los derechos de autonomía y privacidad de los padres de intención, el derecho a la privacidad de los donantes y el derecho de los menores a conocer su origen genético. En este artículo se exponen argumentos para considerar políticas de mayor apertura para la obtención de información de los donantes en aras de proteger el interés superior del niño y la niña a conocer sus orígenes genéticos. Concluye con la problemática en México, donde desde hace varios años se realizan técnicas de reproducción humana asistida con gametos donados, sin embargo, debido a la ausencia de una normatividad que regule estos procedimientos, cada establecimiento impone sus criterios para el funcionamiento de sus programas.

[Current trends in gamete donation - psychosocial and ethical issues]. / Soucasné trendy v psychosociální a etické problematice dárcovství gamet.

OBJECTIVE: To overview contemporary knowledge of legal and psychosocial rules in gamete donation. Previously, anonymous donation was preferred and recommended by experts but currently, with respect to the right to know the genetic origin of individuals, the relation to donor anonymity was reconsidered in many countries. There is a growing tendency to introduce the open identity system in gamete donation. Such system may guarantee that the child born after gamete donation may have receive the identification data of the donor of gametes. DESIGN: A review. SETTING: Clinic of Reproductive Medicine and Gynecology Zlin. METHODS: An overview of recent literature evaluating the influence of donor anonymity vs. open identity on psychosocial development of children born after gamete donation as well as on the quality of the relationship between parents and children in such families. CONCLUSION: New medical technologies usually overtake the developmental speed of ethics and psychology, and their impact on human society. Current trend to open identity is strong but there is no clear evidence that the open identity is of real importance for the healthy psychosocial development of a child born after gamete donation. Furthermore, there is no evidence that anonymity and secrecy of the gamete donation is harmful. In case of the consideration of the change in legal regulation in anonymity/open identity in gamete donation we would suggest the thorough consideration of all consequences.

The Legalisation of Gamete Donation in Italy.

Since 2004, the regulation of assisted reproduction in Italy has undergone substantial reform as an effect of key judicial intervention. Limitations on embryo production, screening and transfer, the prohibition against engaging in preimplantation genetic diagnosis (PGD) and embryo selection, and the ban on gamete donation have all been removed by courts. In this article, I discuss how judicial intervention has improved the ability of Italian couples to access assisted reproduction technologies (ARTs), and how the expansion of reproductive rights is, however, still incomplete. In particular, I discuss the challenges in implementing the liberalisation of gamete donation, and identify the practical, political and cultural reasons for limited access to gamete donation. I also discuss the future of the prohibitions and restrictions that still exist in Law 40/2004.

Good eggs? Evaluating consent forms for egg donation.

Beyond gaps in the provision of information, the informed consent process for egg donation is complicated by conflicts of interest, payment and a lack of longitudinal data about physiological and psychological risks. Recent scholarship has suggested that egg donation programmes could improve the informed consent process by revising consent documents. At a minimum, these documents should include information about eight key criteria: the nature and objectives of treatment; the benefits, risks and inconveniences of egg donation; the privacy of donors and their anonymity (where applicable); disclosure that participation is voluntary (withdrawal); the availability of counselling; financial considerations; the possibility of an unsuccessful cycle and potential uses of the eggs retrieved. This study evaluates the incorporation of these minimum criteria in consent forms for egg donation, obtained through requests to Canadian fertility clinics. Even when clinics were considered to have met criteria simply by mentioning them, among the eight consent forms assessed, none met the minimum standards. Only half of clinics addressed privacy/anonymity concerns, financial issues and the possibility of a future cycle. Improving the quality of consent documentation to meet the minimum standards established by this study may not be an onerous task. For some, this will include re-evaluating how they include one or two elements of disclosure, and for others, this will require a substantial overhaul. Using the criteria provided by this study as the minimum standard for consent could ensure that donors have the basic information they need to make informed decisions.

Attitudes about donor information differ greatly between IVF couples using their own gametes and those receiving or donating oocytes or sperm.

OBJECTIVE: The objective of the study is to examine attitudes towards aspects of donation treatment based on a national Swedish sample of gamete donors and couples undergoing assisted reproductive techniques (ART). METHODS: The present study was part of the Swedish study on gamete donation, a prospective longitudinal cohort study including all fertility clinics performing gamete donation in Sweden. The sample comprised 164 oocyte donors, 89 sperm donors, 251 people treated with their own gametes (in vitro fertilisation (IVF)), 213 oocyte recipients and 487 sperm recipients. A study-specific questionnaire was used. RESULTS: Attitudes vary widely between couples using their own gametes for IVF and those receiving or donating oocyte or sperm. The groups differed in their responses to most questions. Oocyte and sperm donors were more likely to agree with the statements "The donor should be informed if the donation results in a child" and "Offspring should receive some information about the donor during mature adolescence" than recipients of donated gametes and couples treated with their own gametes. CONCLUSION: Donor recipients, IVF couples and donors expressed different attitudes towards openness and information when it came to gamete donation, and those differences seemed to depend on their current reproductive situation.

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.

Genes and gestation in Australian regulation of egg donation, surrogacy and mitochondrial donation.

This article considers genetic and legal relatedness for the purposes of Australian regulation of egg donation, surrogacy and parentage by examination of that regulation through the lens of mitochondrial (mt) donation. The article addresses whether mt donors would be a child's genetic parents following clinical use in that child's conception should mt donation be legalised for such use in Australia. It then considers how genetic and gestational relatedness are relevant in the discourse around legal parentage following egg donation and surrogacy and argues that the current approach is in need of reform so that intending parents of all children are deemed to be the resulting child's legal parents at birth.

The limits of evidence: evidence based policy and the removal of gamete donor anonymity in the UK.

This paper will critically examine the use of evidence in creating policy in the area of reproductive technologies. The use of evidence in health care and policy is not a new phenomenon. However, codified strategies for evidence appraisal in health care technology assessments and attempts to create evidence based policy initiatives suggest that the way evidence is used in practice and policy has changed. This paper will examine this trend by considering what is counted as 'good' evidence, difficulties in translating evidence into policy and practice and how evidence interacts with principles. To illustrate these points the removal of gamete donor anonymity in the UK in 2005 and the debates that preceded this change in the law will be examined. It will be argued that evidence will only ever take us so far and attention should also be paid to the underlying principles that guide policy. The paper will conclude with suggestions for how underlying principles can be more rigorously used in policy formation.

ESHRE Task Force on Ethics and Law 21: genetic screening of gamete donors: ethical issues.

This Task Force document explores the ethical issues involved in the debate about the scope of genetic screening of gamete donors. Calls for expanded donor screening arise against the background of both occasional findings of serious but rare genetic conditions in donors or donor offspring that were not detected through present screening procedures and the advent of new genomic technologies promising affordable testing of donors for a wide range of conditions. Ethical principles require that all stakeholders' interests are taken into account, including those of candidate donors. The message of the profession should be that avoiding all risks is impossible and that testing should remain proportional.

Proposed legislative change mandating retrospective release of identifying information: consultation with donors and Government response.

STUDY QUESTION: How do gamete donors who presumed they could remain anonymous respond to proposed legislation to retrospectively remove anonymity? SUMMARY ANSWER: A little more than half of the donors opposed the recommendation to introduce legislation to remove donor anonymity with retrospective effect. WHAT IS KNOWN ALREADY: An increasing proportion of parents disclose their origins to their donor-conceived children and growing numbers of donor-conceived adults are aware of how they were conceived. Research indicates that access to information about the donor is important to donor-conceived people. However, worldwide most donor-conceived people are unable to find any identifying information about the donor because of the practice of anonymous gamete donation. STUDY DESIGN, SIZE, DURATION: This study adopted a qualitative research model using semi-structured interviews with gamete donors that included open questions. Interviews with 42 volunteers were conducted between December 2012 and February 2013. PARTICIPANTS/MATERIALS, SETTING, METHODS: Before 1998 gamete donors in Victoria, Australia, were able to remain anonymous. Pre-1998 donors were invited through an advertising campaign to be interviewed about their views on a recommendation that legislation mandating retrospective release of identifying information be introduced. MAIN RESULTS AND THE ROLE OF CHANCE: Donors were almost evenly split between those who supported and those who rejected the recommendation to introduce legislation to remove donor anonymity with retrospective effect. About half of the donors who rejected the recommendation suggested the compromise of persuading donors voluntarily to release information (whether identifying or non-identifying) to donor-conceived people. These donors were themselves willing to supply information to their donor offspring. The findings of this study informed the Victorian Government's response to the proposed legislative change. While acknowledging donor-conceived people's right of access to information about their donors, the Government decided that identifying information should be released only with the consent of donors and that donors should be encouraged to allow themselves to be identifiable to their donor offspring. LIMITATIONS, REASONS FOR CAUTION: There is no way of knowing whether participants were representative of all pre-1998 donors. WIDER IMPLICATIONS OF THE FINDINGS: The balancing of donors' and donor-conceived people's rights requires utmost sensitivity. All over the world, increasing numbers of donor-conceived people are reaching adulthood; of those who are aware of their mode of conception, some are likely to have a strong wish to know the identity of their donors. Legislators and policy-makers in jurisdictions permitting anonymous gamete donations will need to respond when these desires are expressed, and may choose to be guided by the model of consultation described in this paper. STUDY FUNDING/COMPETING INTERESTS: The study was funded by the Victorian Department of Health. The authors have no conflicts of interest to declare. TRIAL REGISTRATION NUMBER: Not applicable.

In search of donor relations and identity: the missing voices of Israel's children.

The voices of donor offspring and their families are missing from the debate regarding gamete donor anonymity v. openness in Israel, their unique predicament unheeded. Despite a context of worldwide change, various fears and myths impede the outlawing of donor anonymity, with Israel's medical establishment and legal representatives invested in maintaining a status quo characterized by regulations that discriminate between families whose members know their biological parents/siblings and those who do not. The most prominent of these is that abolishing anonymity leads to long-term shortage of donors, despite well-documented evidence to the contrary. A review of key research findings regarding the particular needs and experiences of offspring, recipients and donors clearly supports the need for a well thought-out re-evaluation of persistent fears and myths via the prism of grassroots reality. This evidence-based approach can lead to the formulation of recommendations that should facilitate, reflect and constitute such policy change.

Is the HFEA's policy on compensating egg donors and egg sharers defensible?

This paper asks whether the Human Fertilisation and Embryology Authority's (HFEA's) recently revised policies on compensating egg donors and egg sharers are defensible, paying particular heed to the ethical arguments, concepts, and principles deployed in support of them. The paper proceeds by briefly outlining both the 'old' and 'new' HFEA policies before describing and explaining the main arguments that are supposed to underpin these. The arguments are then subjected to scrutiny and generally found wanting. The paper's primary conclusion is that treating egg sharers more generously than egg donors (which is what both the 'old' and 'new' policies do) is inconsistent and unjustified. In order to render the HFEA's policies consistent, it would need either to limit more strictly the benefits-in-kind available to egg sharers or to take a more permissive approach to monetary compensation for egg donors. The paper's secondary conclusion is that the latter is preferable. Egg donors could, provided that suitable regulatory controls were in place, be compensated more generously without this being ethically problematic. Furthermore, since egg sharing is in some respects more problematic than other forms of egg donation, there is something to be said for encouraging a move away from sharing to donation.

Donor identification 'kills gamete donation'? A response.

Two Australian government inquiries have recently called for the release of information to donor-conceived people about their gamete donors. A national inquiry, recommended 'as a matter of priority' that uniform legislation to be passed nationwide. A state-based inquiry argued that all donor-conceived people should have access to information and called for the enactment of retrospective legislation that would override donor anonymity. This paper responds to an opinion piece published in Human Reproduction in October 2012 by Professor Pennings in which he criticized such recommendations and questioned the motives of people that advocate for information release. I answer the arguments of Pennings, and argue that all parties affected by donor conception should be considered, and a compromise reached. The contact veto system is one such compromise. I discuss the education and support services recommended by the Victorian government and question Pennings' assertions that legislation enabling information release will lead to a decrease in gamete donation. Finally, I rebut Pennings' assertion that there is a 'hidden agenda' behind the call for information release. There is no such agenda in my work. If there is from others, then it is their discriminatory views that need to be addressed, not the move toward openness and honesty or the call for information by donor-conceived people.

How to kill gamete donation: retrospective legislation and donor anonymity.

Victoria (Australia) is considering retrospective legislation on the abolition of gamete donor anonymity. Retrospective legislation evokes many negative emotions mainly because it is considered unfair. It also makes it impossible for citizens to organize their life with reasonable certainty of the consequences. Introduction of this law for donor anonymity is defended by the right of the child to know its genetic origins. Against this law, people appeal to the right to privacy and confidentiality of the donor. This paper analyses the arguments for and against a retrospective law on donor anonymity by looking at the conditions that should be respected when two principles (the donor's right to privacy and the child's right to genetic information) have to be balanced. It is concluded that the justification for introducing retrospective law is lacking: the conditions are not fulfilled. Moreover, retroactive laws in the context of gamete donation may jeopardize the whole practice by destroying the trust of candidate donors and recipients in the government.

Disclosure behaviour and intentions among 111 couples following treatment with oocytes or sperm from identity-release donors: follow-up at offspring age 1-4 years.

STUDY QUESTION: Do heterosexual parents of young children following oocyte donation (OD) and sperm donation (SD) tell or intend to tell their offspring about the way he/she was conceived? SUMMARY ANSWER: Following successful treatment with oocytes or sperm from identity-release donors in Sweden, almost all heterosexual couples intend to tell their offspring about the way he/she was conceived and some start the information-sharing process very early. WHAT IS KNOWN AND WHAT THIS PAPER ADDS: Although the Swedish legislation on identity-release gamete donors has been in effect since 1985, there is a discrepancy between the behaviour of donor-insemination parents and the legal intention that offspring be informed about their genetic origin. The present study contributes data on a relatively large sample of oocyte and sperm recipient couples' intended compliance with the Swedish legislation. DESIGN AND DATA COLLECTION METHOD: The present study constitutes a follow-up assessment of heterosexual couples who had given birth to a child following treatment with donated oocytes. Data collection was performed during 2007-2011; participants individually completed a questionnaire when the child was between 1 and 4 years of age. PARTICIPANTS AND SETTING: The present study is part of the Swedish Study on Gamete Donation, a prospective longitudinal cohort study including all fertility clinics performing gamete donation in Sweden. For children conceived via OD, 107 individuals (including 52 couples and 3 individuals) agreed to participate (73% response). For children conceived via SD, the response rate was 70% (n = 122 individuals, including 59 couples and 4 individuals). Mean age of participants was 34 years (SD 4.4) and they reported a high level of education. MAIN RESULTS: The majority of participants (78%) planned to tell the child about the donation, 16% had already started the information-sharing process and 6% planned not to tell their child about the donation or were undecided. Many were unsure about a suitable time to start the disclosure process and desired more information about strategies and tools for information sharing. Agreement on disclosure to offspring within the couple was related to the quality of the partner relationship. BIAS AND GENERALIZABILITY: There is a risk of selection bias, with gamete recipients preferring secrecy and non-disclosure declining study participation. The results may be regarded as partly generalizable to heterosexual couples with young children following treatment with gametes from legislatively mandated identity-release donors in an established donor programme. STUDY FUNDING/COMPETING INTERESTS: Study funding by Merck Serono, The Swedish Research Council and The Family Planning Fund in Uppsala. No conflicts of interest to declare.

China's model of egg donation is a policy lesson for Britain.

In a move designed to increase the UK's supply of donor eggs, the Human Fertilisation and Embryology Authority has recently agreed to a fixed-sum compensation policy for donors "which better reflects their expenses" and inconvenience. Such a policy, however, which is reliant on non-patient donors for its success, is in contrast to what appears the system in China, where egg donors can only be recruited from those having IVF (i.e. patient donors) and on a conditional egg-sharing basis. Commitment to an egg-sharing policy in the UK would provide a more equitable system of egg donation than a compensation policy.