Survey on ART and IUI: legislation, regulation, funding, and registries in European countries-an update.

STUDY QUESTION: How are ART and IUI regulated, funded, and registered in European countries, and how has the situation changed since 2018? SUMMARY ANSWER: Of the 43 countries performing ART and IUI in Europe, and participating in the survey, specific legislation exists in only 39 countries, public funding varies across and sometimes within countries (and is lacking or minimal in four countries), and national registries are in place in 33 countries; only a small number of changes were identified, most of them in the direction of improving accessibility, through increased public financial support and/or opening access to additional subgroups. WHAT IS KNOWN ALREADY: The annual reports of the European IVF-Monitoring Consortium (EIM) clearly show the existence of different approaches across Europe regarding accessibility to and efficacy of ART and IUI treatments. In a previous survey, some coherent information was gathered about how those techniques were regulated, funded, and registered in European countries, showing that diversity is the paradigm in this medical field. STUDY DESIGN, SIZE, DURATION: A survey was designed using the SurveyMonkey tool consisting of 90 questions covering several domains (legal, funding, and registry) and considering specific details on the situation of third-party donations. New questions widened the scope of the previous survey. Answers refer to the situation of countries on 31 December 2022. PARTICIPANTS/MATERIALS, SETTINGS, METHODS: All members of the EIM were invited to participate. The received answers were checked and initial responders were asked to address unclear answers and to provide any additional information considered relevant. Tables resulting from the consolidated data were then sent to members of the Committee of National Representatives of ESHRE, requesting a second check. Conflicting information was clarified by direct contact. MAIN RESULTS AND THE ROLE OF CHANCE: Information was received from 43 out of the 45 European countries where ART and IUI are performed. There were 39 countries with specific legislation on ART, and artificial insemination was considered an ART technique in 33 of them. Accessibility is limited to infertile couples only in 8 of the 43 countries. In 5 countries, ART and IUI are permitted also for treatments of single women and all same sex couples, while a total of 33 offer treatment to single women and 19 offer treatment to female couples. Use of donated sperm is allowed in all except 2 countries, oocyte donation is allowed in 38, simultaneous donation of sperm and oocyte is allowed in 32, and embryo donation is allowed in 29 countries. Preimplantation genetic testing (PGT)-M/SR (for monogenetic disorders, structural rearrangements) is not allowed in 3 countries and PGT-A (for aneuploidy) is not allowed in 10; surrogacy is accepted in 15 countries. Except for marital/sexual situation, female age is the most frequently reported limiting criterion for legal access to ART: minimal age is usually set at 18 years and the maximum ranges from 42 to 54 with some countries not using numeric definition. Male maximum age is set in very few countries. Where third-party donors are permitted, age is frequently a limiting criterion (male maximum age ranging from 35 to 50; female maximum age from 30 to 37). Other legal restrictions in third-party donation are the number of children born from the same donor (or, in some countries, the number of families with children from the same donor) and, in 12 countries, there is a maximum number of oocyte donations. How countries deal with the anonymity is diverse: strict anonymity, anonymity just for the recipients (not for children when reaching legal adulthood age), a mixed system (anonymous and non-anonymous donations), and strict non-anonymity. Inquiring about donors' genetic screening showed that most countries have enforced either mandatory or scientific recommendations that exclude the most prevalent genetic diseases, although, again, diversity is evident. Reimbursement/compensation systems exist in more than 30 European countries, with around 10 describing clearly defined maximum amounts considered acceptable. Public funding systems are extremely variable. One country provides no financial assistance to ART/IUI patients and three offer only minimal support. Limits to the provision of funding are defined in the others i.e. age (female maximum age is the most used), existence of previous children, BMI, maximum number of treatments publicly supported, and techniques not entitled for funding. In a few countries reimbursement is linked to a clinical policy. The definitions of the type of expenses covered within an IVF/ICSI cycle, up to which limit, and the proportion of out-of-pocket costs for patients are also extremely dissimilar. National registries of ART are in place in 33 out of the 43 countries contributing to the survey and a registry of donors exists in 19 of them. When comparing with the results of the previous survey, the main changes are: (i) an extension of the beneficiaries of ART techniques (and IUI), evident in nine countries; (ii) public financial support exists now in Albania and Armenia; (iii) in Luxembourg, the only ART centre expanded its on-site activities; (iv) donor-conceived children are entitled to know the donor identity in six countries more than in 2018; and (v) four more countries have set a maximum number of oocyte donations. LIMITATIONS, REASONS FOR CAUTION: Although the responses were provided by well-informed and committed individuals and submitted to double checking, no formal validation by official bodies was in place. Therefore, possible inaccuracies cannot be excluded. The results presented are a cross-section in time, and ART and IUI frameworks within European countries undergo continuous modification. Finally, some domains of ART activity were deliberately left out of the scope of this survey. WIDER IMPLICATIONS OF THE FINDINGS: Our results offer a detailed updated view of the ART and IUI situation in European countries. It provides extensive answers to many relevant questions related to ART usage at the national level and could be used by institutions and policymakers at both national and European levels. STUDY FUNDING/COMPETING INTEREST(S): The study has no external funding, and all costs were covered by ESHRE. There were no competing interests.

The law on artificial insemination: an italian anomaly.

The law on medically assisted procreation in Italy, from its entering into force, has undergone numerous amendments. This has been due to the fact that those citizens, directly affected by its imposed prohibitions, have not given in, bringing their requests before the courts, both nationally and internationally. Over the years, the courts through numerous rulings have significantly changed a law clearly incapable of protecting the rights of those involved. Currently Italy has an acceptable law on M.A.P. which is the result of the strong willing of citizens affected by problems of sterility or infertility. The aim of this paper is to present an historical summary of the troubled path which the issue, from every perspective, has faced and is still facing today. As well, it will document how, in Italy, the case-law and, therefore, the law's interpretation and application by the judges have contributed, in the end, to shaping a positive legislation.

La Ley de Reproducción Asistida vista por un ginecólogo / No disponible

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Cross-border reproductive care for law evasion: a qualitative study into the experiences and moral perspectives of French women who go to Belgium for treatment with donor sperm.

One consequence of the legal diversity in Europe is that legal restrictions on treatments can be evaded by going abroad. Many French lesbian couples and single women are crossing the border to Belgium because they are denied access to treatments with donor sperm at home. This is the first qualitative research study into the experiences and moral perspectives of these women. Between June 2012 and May 2013, 11 lesbian couples and 2 single women were recruited at the department of reproductive medicine at Ghent University Hospital. The data from the semi-structured interviews was analysed using inductive thematic analysis. The results show that these women face several additional challenges to the already difficult process of cross-border treatment. Before they can start the treatment, they can only obtain information from the internet or from stories of friends who also went abroad for treatment with donor sperm. During the treatment, they need to find local clinics or physicians to monitor their cycle. Several women managed to game the French system to ensure partial reimbursement for their treatment when they were successful in finding a physician who was willing to prescribe drugs and perform tests. Most women had difficulties justifying their absence from work. In general these women felt that they were discriminated against and that their rights were not protected because of who they are. In that regard, the lack of legal recognition of the genetically unrelated partner in their country was particularly hard to cope with for the lesbian couples. These women have to develop many different strategies to deal with the difficulties they face during cross-border reproductive care. It is concluded that it is very important that they find a physician who is willing to support them in their 'baby project'.

Gamete donation in France: the future of the anonymity doctrine.

In France, since the approval of the first bioethics laws in 1994, the principle of the anonymity of sperm donors has prevailed. This choice is regularly challenged, namely by children who have been conceived under these conditions and have now reached adulthood. In this paper, we will briefly describe the reasons that led practitioners of assisted reproduction to endorse the anonymity principle in 1994. Secondly, we will elaborate on the reasons why this principle is becoming so controversial today. Finally, we shall examine two possible outcomes of the debate, highlighting their respective legitimacy as well as their consequences, as far as the rights of children, the notion of the family, and medical practice are concerned.

Sperm retrieval from terminally ill or recently deceased patients: a review.

OBJECTIVE: Requests for sperm extraction in terminally ill or recently deceased patients have been increasing with the gained acceptance and success of assisted reproductive techniques such as in vitro fertilization and intracytoplasmic sperm injection. This review aims to outline the many challenges associated with these requests. MATERIALS AND METHODS: The medical literature surrounding ethical and legal issues of posthumous sperm extraction was examined. RESULTS: Several issues within the field of sperm extraction in the terminally ill patient and the postmortem patient still arouse a significant amount of debate and controversy. One controversial factor surrounds the issue of consent for the tissue extraction and determining when family consent is valid. Other discussions have involved ethical issues, logistics (including cost), and legal issues. CONCLUSIONS: A medical center protocol governing sperm extraction from terminally ill or recently deceased patients would be beneficial, and would likely alleviate stress among the patients' families and healthcare providers. To overcome some of the difficulties surrounding the issue of consent, it might also be valuable for men about to get married or enter into a similar relationship to document their wishes for sperm retrieval should a tragic situation arise. This could be done in the same way that they would prepare a living will.

[Infertility treatment in men with Klinefelter syndrome]. / Assistert befruktning ved Klinefelters syndrom.

BACKGROUND: Klinefelter syndrome is the most common chromosomal aberration in men with azoospermia. The revision of the Norwegian biotechnology law in 2004 allows infertile couples with this diagnosis to become genetic parents. Surgical sperm extraction has to be performed to enable identification of possible sperm production. The preliminary approval to use this procedure (stated in the biotechnology law) was extended in 2007. This paper presents a short overview of the infertility investigation and treatment in men with Klinefelter syndrome. MATERIAL AND METHODS: The paper is based on more than 10 years of clinical experience in workup and treatment of infertile couples with the diagnosis Klinefelter syndrome. In addition, a non-systematic search in Pubmed and Medline has been carried out. RESULTS: Use of a microscopy during testicular sperm extraction increases the possibility of finding sperm in men with Klinefelter syndrome. The microsurgical procedure also reduces the risk of complications. If the diagnostic recovery has identified testicular sperm, there is a high predictive value of finding sperm in a subsequent surgical procedure. INTERPRETATION: The optimal method for successful sperm recovery in men with Klinefelter syndrome implies the use of microsurgery. This surgical method should therefore be considered established in Norway.