Análisis bioético (subjetivismo moral) desde la percepción de los clínicos sobre la situación de los embriones sometidos a fecundación in vitro. Quito-Ecuador / Bioethical analysis (moral subjectivism) from the perception of clinicians on the situation of embryos subjected to in vitro fertilization. Quito-Ecuador / Análise bioética (subjetivismo moral) a partir da percepção dos médicos sobre a situação dos embriões submetidos à fertilização in vitro. Quito-Equador

Resumen: Objetivo. Analizar las percepciones y prácticas de los clínicos en relación con el manejo del embrión sometido a técnicas de fecundación in vitro. Metodología. Cualitativa (subjetivista y fenomenológico). Se realizaron 15 las entrevistas semiestructuradas aplicando un muestreo por saturación dirigidas a personal clínico que haya participado en procedimientos de fecundación in vitro. Los datos se analizaron con el programa Atlas Ti 8.0®. Resultado. Los clínicos consideran al embrión como un ser humano o futuro ser humano y, además, merecedor de respeto y consideración, proponiendo incluso mejoras en los procesos de manipulación y almacenaje. Conclusión. Los embriones no son considerados como entes susceptibles de recibir daño, desde argumentos no solo técnicos sino éticos. Desde la corriente principialista, se describe la necesidad de promover actitudes de responsabilidad y prudencia para evitar el dogmatismo (objetivismo moral) proponiendo una postura deliberativa.

Abstract: The objective of this paper is to analyze the perceptions and practices of clinicians in relation to the management of embryos subjected to in vitro fertilization techniques. Methodology is Qualitative (subjectivist and phenomenological). A total of 15 semi-structured interviews were conducted using saturation sampling for clinical personnel who have participated in vitro fertilization procedures. The data is analyzed with the Atlas Ti 8.0® program. Results: Clinicians consider the embryo as a Human being or future human being, in addition, deserving of respect and consideration even proposing improvements in the processes of handling and storage. Conclusion. Embryos are not considered as entities susceptible of damage from not only technical but ethical arguments. From the principialist current, the need to promote attitudes of responsibility and prudence to avoid dogmatism (moral objectivism) is described, proposing a deliberative position.

Resumo: Objetivo. Analisar as percepções e práticas dos médicos em relação ao manejo do embrião submetido a técnicas de fertilização in vitro. Metodologia. Qualitativo (subjetivo e fenomenológico). Foram realizadas 15 entrevistas semiestruturadas por amostragem de saturação para pessoal clínico que participou de procedimentos de fertilização in vitro. Os dados são analisados com o programa Atlas Ti 8.0®. Resultado. Os médicos consideram o embrião como um ser humano ou futuro, além de merecer respeito e consideração, propondo até melhorias nos processos de manuseio e armazenamento. Conclusão. Os embriões não são considerados como entidades suscetíveis a receber danos não apenas de argumentos técnicos, mas éticos. A partir da corrente principialista, descreve-se a necessidade de promover atitudes de responsabilidade e prudência para evitar o dogmatismo (objetivismo moral), propondo uma posição deliberativa.

Ethics and IVF add-ons: We need to talk about it.

In vitro fertilization (IVF) 'add-ons' are adjunct treatments used in addition to standard IVF protocols, in an attempt to improve success rates. However, the benefits for add-ons are often not supported by high-quality evidence. Nevertheless, many infertile patients are willing to try anything that might help them to improve their chances of having a baby. Therefore, the use of add-ons has been widespread and has led to extensive debate and discussion. The goal of this manuscript was to discuss the ethics underling the use of adjunct therapies in clinical practice before their safety has been thoroughly ascertained. IVF patients are routinely offered and charged for a wide range of adjunct treatments that they are told may improve their chance of a live birth, despite there being no clinical evidence supporting such efficacy. Add-on treatments are well accepted by most infertile patients, especially those who have already started their IVF treatments. A particular concern is that many clinics around the world are advertising and offering clinical adjuncts to infertile couples undergoing IVF, however, information on add-ons is often inaccurate. Data concerning the lack of scientific evidence supporting add-on efficacy and whether an add-on may cause unanticipated harm or worsen treatment outcomes is not available on most websites. IVF patients are a vulnerable population, thus there is a need for transparency about interventions for IVF, including uncertainties and risks, to support patient decision-making regarding the use of certain adjunctive therapies. Such information can be provided by clear guidelines and effective regulation.

Disposition of unclaimed embryos: an Ethics Committee opinion.

Programs should create and enforce written policies addressing the designation, retention, and disposal of unclaimed embryos. In the absence of program-specific policies, it is ethically permissible for a program or facility to consider embryos to have been unclaimed if a reasonable period of time has passed since contact with an individual or couple; efforts as outlined in the consent form have been made to contact the individual or couple; and no written instructions from the individual or couple with dispositional control exist concerning disposition. In such cases, programs or facilities may dispose of unclaimed embryos by removing them from storage and thawing without transfer. In the absence of specific written instructions, unclaimed embryos may not be donated to others for reproductive use or be used in research. This statement replaces the American Society for Reproductive Medicine Ethics Committee document "Disposition of Abandoned Embryos" published in 2013.

The ethics of human-embryoids model: a call for consistency.

In this article, we discuss the ethics of human embryoids, i.e., embryo-like structures made from pluripotent stem cells for modeling natural embryos. We argue that defining our social priorities is critical to design a consistent ethical guideline for research on those new entities. The absence of clear regulations on these emerging technologies stems from an unresolved debate surrounding natural human embryo research and one common opinion that one needs to solve the question of the moral status of the human embryo before regulating their surrogate. The recent NIH funding restrictions for research on human embryoids have made scientists even more unlikely to raise their voices. As a result, the scientific community has maintained a low profile while longing for a more favorable socio-political climate for their research. This article is a call for consistency among biomedical research on human materials, trying to position human embryoids within a spectrum of existing practice from stem cell research or IVF to research involving human subjects. We specifically note that the current practices in infertility clinics of freezing human embryos or disposing of them without any consideration for their potential benefits contradicts the assumption of special consideration for human material. Conversely, creating human embryoids for research purposes could ensure that no human material be used in vain, always serving humankind. We argue here that it is time to reconsider the full ban on embryo research (human embryos and embryoids) beyond the 14-day rule and that research on those entities should obey a sliding scale combining the completeness of the model (e.g., complete vs. partial) and the developmental stage: with more advanced completeness and developmental stage of the considered entity, being associated with more rigorous evaluation of societal benefits, statements of intention, and necessity of such research.

Medical research and reproductive medicine in an ethical context: a critical commentary on the paper dealing with uterine lavage published by Munné et al.

A recent study published in Human Reproduction claimed that uterine lavage offers a non-surgical, minimally invasive strategy for the recovery of human embryos from fertile women who do not want or need IVF for medical reasons but who desire preimplantation genetic testing (PGT) for embryos. To prove this hypothesis, the researchers recruited dozens of young Mexican women. The prospective oocyte donors underwent ovarian stimulation to induce the production of multiple mature oocytes. Subsequently, these women were inseminated by donor semen. A few days later, the developing embryos were collected by uterine lavage (uterine flushing) and subjected to genetic testing for aneuploidies (PGT-A). Oocyte donors with persistently elevated hCG levels, indicating the implantation of one or more embryos after uterine lavage, had to undergo uterine curettage and/or treatment with methotrexate. A critical opinion paper discussing the aforementioned study was published by De Santis and colleagues and has raised critical issues that are largely technical in nature. However, this opinion paper neglects-from our point of view-critical issues of the Mexican study regarding ethical principles and moral standards in human research. These aspects are summarized below.

[Polygenic scores: towards designer babies?] / Scores polygéniques : vers l'embryon à la carte ? - Chroniques génomiques.

A new company is offering extensive genetic analysis of embryos during an in vitro fertilisation procedure, allowing the derivation of polygenic scores for several diseases and embryo choice based on these results. Polygenic scores, if properly implemented, can indeed have substantial predictive value, and the possibility of embryo choice based on these data has become real, raising a number of practical and ethical problems. ‡.

Assessment of Turkey IVF (In Vitro Fertilization) websites according to the American Society for Reproductive Medicine (ASRM)/Society for Assisted Reproductive Technology (SART) guidelines.

OBJECTIVE: To evaluate websites of in-vitro fertilisation centres in terms of standardised ethical guidelines for advertising. METHODS: The cross-sectional study was conducted in Turkey from February to April 2017. A total of 148 IVF centre websites were evaluated in terms of objective criteria in accordance with American Medical Association, American College of Obstetricians and Gynaecologists, American Society for Reproductive Medicine / Society for Assisted Reproductive. Technology guidelines for advertising. Websites were surveyed with attention paid to success rates, testimonials, sales promotions, price, psychological support offered as part of the service, regulating / certifying bodies, misleading language, and the ethical principles of autonomy, beneficence, non-maleficence and justice. Data was analysed using SPSS 23. RESULTS: Out of 193 centres, 148(76.7%) had active websites; 104(70.3%) private, 38(25.7%) in university hospitals and 6(4%) in state hospitals. Of them, 103(69.6%) centres used at least one example of misleading language when compared to the relevant guidelines. Among these centres, 82(79.6%) were private, 18(17.5%) university hospitals and 3(2.9%) were state hospitals. CONCLUSIONS: A massive majority of websites related to in-vitro fertilisation centres did not follow standardised guidelines for advertising.

Thoughts on the ethics of gestational surrogacy: perspectives from religions, Western liberalism, and comparisons with adoption.

BACKGROUND: In gestational surrogacy, a woman incubates an embryo to which she is not genetically related. Genetic distance from both her and the commissioning parents is increased further when donor gametes are employed. Ethical implications vary depending on the extent to which the parents and surrogates share genetic material with the produced child. PURPOSE: This paper seeks to address two primary questions: What do selected ethical frameworks tell us of (1) the relationship between genetic motherhood, gestational motherhood, social motherhood, and marital fidelity? And (2) the effects of gestational surrogacy and gamete donation on our understanding of lineage and heritability? METHODS: Current literature and thought on these questions were considered through the classical ethics lenses of religion, the adoption standard, and Western liberalism. RESULTS: A genetic link between the parents and the child serves to simplify the adoption process (if one is required) and supports a family's desire to resemble as much as possible a traditional biological family, thus providing a minimum set of challenges to religious or conservative hesitations. CONCLUSION: Inasmuch as gestational surrogacy, with or without donor gametes, is tolerated in a variety of ethical contexts; the basis of its acceptance may be the Western liberal celebration of contractual agreement.

Decisional authority of gamete donors over embryos created with their gametes.

In the ongoing discussion on the rights and obligations of gamete donors, scant attention has been paid to the decisional authority of gamete donors over the disposition of the embryos created with their gametes. This paper analyses four different positions: three cases relate to the disposition options for surplus or unused embryos by the first recipients, and one case relates to the use of the embryos stored by the first recipients for procreation.We conclude that the gamete donor causally contributes to the creation of the embryos and thus becomes indirectly responsible. To avoid that donors would become accomplices to an activity to which they morally object, a qualified generic consent mentioning types of research should be obtained. No consent from the donor is required for the destruction of the embryos.The cancellation of the agreement by anonymous or identifiable gamete donors should not be possible for embryos in storage for reproduction by the recipients. The interests in not becoming a genetic parent against one's wishes do not outweigh the damage done to recipients who would no longer be able to use their embryos. Known donors, on the contrary, should be able to withdraw their consent up to the moment of transfer of the embryos based on the greater harm caused to them as a consequence of attributional parenthood. They should also be able to veto transfer of the embryos to other people than the original recipients.

Use of in vitro fertilization-ethical issues.

This report is an ethical analysis based on both facts and values. In in vitro fertilization (IVF), there is an intricate interaction between rapid scientific development and changing societal values. In most countries, the ethical discussion is no longer on whether or not IVF in itself is ethically justifiable. Therefore, in this review, I discuss other ethical aspects that have emerged since IVF was first introduced, such as upper age limits, 'ownership' of gametes and embryos, IVF in single women and same-sex couples, preimplantatory genetic testing, social egg freezing, commercialization, public funding, and prioritization of IVF. Despite secularization, since religion still plays an important role in regulation and practices of IVF in many countries, positions on IVF among the world religions are summarized. Decision-making concerning IVF cannot be based only on clinical and economic considerations; these cannot be disentangled from ethical principles. Many concerns regarding the costs, effects, and safety of IVF subtly transcend into more complex questions about what it means to society to bear and give birth to children.

Regulating assisted reproductive technologies (ART) in Nigeria: lessons from Australia and the United Kingdom.

Assisted reproductive technologies (ART), are innovative, non-coital medical procreative procedures, that have brought respite to a number of childless persons and couples, just as it also raises a number of ethical and medico-legal issues. A number of countries including Nigeria, are still struggling to find the appropriate legal framework to provide guidelines for this reproductive process to curtail inherent unethical practices associated with that development. The paper explores the available regulatory instruments in Nigeria and in cognate jurisdictions such as Australia and the United Kingdom, through a comparative study to ascertain the efficacy of the existing instruments in ensuring that unethical practices and abuses associated with ART are eradicated. The findings indicate that the regulatory instrument in Nigeria requires significant improvement in line with the legal frameworks in operation in the cognate jurisdictions to effectively guard against potential unethical practices and abuses associated with the application of ART.

Safety of Germline Genome Editing for Genetically Related "Future" Children as Perceived by Parents.

The social acceptability of germline genome editing (GGE) depends on its perceived safety, as well as respect for reproductive autonomy. However, it is doubtful that prospective parents sufficiently understand the risks of GGE. In the future, the use of GGE in specific situations seems plausible, as it offers couples potential means to safeguard genetically related future children from a serious disease and overcome infertility due to a gene mutation. Should GGE fail, however, some couples may be obliged to abort affected fetuses, or give birth to adversely affected children, which would be a tragedy. Some children might develop diseases later in life due to overlooked off-target mutations. Compounding this, some parents are unlikely to inform their offspring about the details of conception, hampering necessary follow-up. Prospective parents, scientists and policy makers should carefully discuss the safety implications of GGE for genetically related future children.

The American Democratic Deficit in Assisted Reproductive Technology Innovation.

In many areas of innovation, the United States is a leader, but this characterization does not apply to the United States' position in assisted reproductive technology innovation and clinical use. This article uses a political science concept, the idea of the "democratic deficit" to examine the lack of American public discourse on innovations in ART. In doing so, the article focuses on America's missing public consultation in health care innovation. This missing discourse is significant, as political and ethical considerations may impact regulatory decisions. Thus, to the extent that these considerations are influencing the decisions of federal agency employees, namely those who work within the U.S. Food and Drug Administration, the public is unable to participate in the decision-making process. This lack of a public discourse undermines the goals of the administrative state, which include democratic participation, transparency, and accountability. The United Kingdom, on the other hand, has had a markedly divergent experience with assisted reproductive technology innovation. Instead of ignoring the various ethical, social, and legal issues surrounding assisted reproductive technology innovation, the United Kingdom engaged in a five-strand public consultation on the topic of mitochondrial transfer, a form of assisted reproductive technology that uses genetic modification in order to prevent disease transmission. This article argues that after a multi-decade standstill in terms of the public discourse related to ethical issues associated with assisted reproductive technology and germline modification, it is time for the United States to institute a more democratic inquiry into the scientific, ethical, and social implications of new forms of assisted reproductive technology and ultimately, forthcoming medical innovations that involve genetic modification.

Do à la carte menus serve infertility patients? The ethics and regulation of in vitro fertility add-ons.

Add-on treatments are the new black. They are provided (most frequently, sold) to patients undergoing in vitro fertilization on the premise that they will improve the chances of having a baby. However, the regulation of add-ons is consistently minimal, meaning that they are introduced into routine practice before they have been shown to improve the live birth rate. Debate on the adequacy of this light-touch approach rages. Defenders argue that demands for a rigorous approval process are paternalistic, as this would delay access to promising treatments. Critics respond that promising treatments may turn out to have adverse effects on patients and their offspring, contradicting the clinician's responsibility to do no harm. Some add-ons, including earlier versions of preimplantation genetic testing for aneuploidy, might even reduce the live birth rate, raising the prospect of desperate patients paying more to worsen their chances. Informed consent represents a solution in principle, but in practice there is a clear tension between impartial information and direct-to-consumer advertising. Because the effects of a treatment cannot be known until it has been robustly evaluated, we argue that strong evidence should be required before add-ons are introduced to the clinic. In the meantime, there is an imperative to identify methods for communicating the associated risks and uncertainties of add-ons to prospective patients.

Estimating Demand for Germline Genome Editing: An In Vitro Fertilization Clinic Perspective.

Germline genome editing (GGE) holds the potential to mitigate or even eliminate human heritable genetic disease, but also carries genuine risks if not appropriately regulated and performed. It also raises fears in some quarters of apocalyptic scenarios of designer babies that could radically change human reproduction. Clinical need and the availability of alternatives are key considerations in the ensuing ethical debate. Writing from the perspective of a fertility clinic, we offer a realistic projection of the demand for GGE. We lay out a framework proposing that GGE, hereditary genetic disorders, and in vitro fertilization are fundamentally entwined concepts. We note that the need for GGE to cure heritable genetic disease is typically grossly overestimated, mainly due to the underappreciated role of preimplantation genetic testing. However, we might still find applications for GGE in the correction of chromosomal abnormalities in early embryos, but techniques for that purpose do not yet exist.

In Vitro Gametogenesis and the Creation of 'Designer Babies'.

Research into the development of stem cell-derived (SCD) gametes in humans, otherwise known as in vitro gametogenesis (IVG), is largely motivated by reproductive aims. Especially, the goal of establishing genetic parenthood by means of SCD-gametes is considered an important aim. However, like other applications in the field of assisted reproduction, this technology evokes worries about the possibility of creating so-called 'designer babies.' In this paper, we investigate various ways in which SCD-gametes could be used to create such preference-matched offspring, and what this would mean for the acceptability of IVG, if it is premised that it is morally problematic to 'design' offspring. We argue that IVG might facilitate the creation of preference-matched offspring, but conclude that this should not undermine the moral acceptability of IVG altogether-even if one concedes the premise that creating 'designer babies' is morally problematic. In the light of this, we also point at a possible inconsistency for a position that condemns the creation of 'designer offspring,' while accepting the various endeavors to have genetically related offspring.

The Ethics of the Societal Entrenchment-approach and the case of live uterus transplantation-IVF.

In 2014, the first child in the world was born after live uterus transplantation and IVF (UTx-IVF). Before and after this event, ethical aspects of UTx-IVF have been discussed in the medical and bioethical debate as well as, with varying intensity, in Swedish media and political fora. This article examines what comes to be identified as important ethical problems and solutions in the media debate of UTx-IVF in Sweden, showing specifically how problems, target groups, goals, benefits, risks and stakes are delineated and positioned. It also demonstrates how specific assumptions, norms and values are expressed and used to underpin specific positions within this debate, and how certain subjects, desires and risks become shrouded or simply omitted from it. This approach-which we label the Ethics of the Societal Entrenchment-approach, inspired by Koch and Stemerding (1994)-allows us to discuss how the identification of something as the problem helps to shape what gets to be described as a solution, and how specific solutions provide frameworks within which problems can be stated and emphasised. We also offer a critical discussion of whether some of these articulations and formations should be seen as ethically troubling, and if so, why.

Preimplantation genetic testing for more than one genetic condition: clinical and ethical considerations and dilemmas.

STUDY QUESTION: Which clinical and ethical aspects of preimplantation genetic testing for monogenic disorders or structural rearrangements (PGT-M, PGT-SR) should be considered when accepting requests and counselling couples for PGT when applied for more than one condition (combination-PGT; cPGT-M/SR)? SUMMARY ANSWER: cPGT is a feasible extension of the practice of PGT-M/SR that may require adapting the criteria many countries have in place with regard to indications-setting for PGT-M/SR, while leading to complex choices that require timely counselling and information. WHAT IS KNOWN ALREADY: Although PGT-M/SR is usually performed to prevent transmission of one disorder, requests for PGT-M/SR for more than one condition (cPGT-M/SR) are becoming less exceptional. However, knowledge about implications for a responsible application of such treatments is lacking. STUDY DESIGN, SIZE, DURATION: Retrospective review of all (40) PGT-M/SR applications concerning more than one genetic condition over the period 1995-2018 in the files of the Dutch national PGT centre. This comprises all relevant national data since the start of PGT in the Netherlands. PARTICIPANTS/MATERIALS, SETTING AND METHODS: Data regarding cPGT-M/SR cases were collected by means of reviewing medical files of couples applying for cPGT-M/SR. Ethical challenges arising with cPGT-M/SR were explored against the background of PGT-M/SR regulations in several European countries, as well as of relevant ESHRE-guidance regarding both indications-setting and transfer-decisions. MAIN RESULTS AND THE ROLE OF CHANCE: We report 40 couples applying for cPGT-M/SR of which 16 couples started their IVF treatment. Together they underwent 39 IVF cycles leading to the birth of five healthy children. Of the couples applying for cPGT, 45% differentiated between a primary and secondary condition in terms of perceived severity. In the light of an altered balance of benefits and drawbacks, we argue the 'high risk of a serious condition' standard that many countries uphold as governing indications-setting, should be lowered for secondary conditions in couples who already have an indication for PGT-M/SR. As a consequence of cPGT, professionals will more often be confronted with requests for transferring embryos known to be affected with a condition that they were tested for. In line with ESHRE guidance, such transfers may well be acceptable, on the condition of avoiding a high risk of a child with a seriously diminished quality of life. LIMITATIONS, REASONS FOR CAUTION: We are the first to give an overview of cPGT-M/SR treatments. Retrospective analysis was performed using national data, possibly not reflecting current trends worldwide. WIDER IMPLICATIONS OF THE FINDINGS: Our observations have led to recommendations for cPGT-M/SR that may add to centre policy making and to the formulation of professional guidelines. Given that the introduction of generic methods for genomic analysis in PGT will regularly yield incidental findings leading to transfer requests with these same challenges, the importance of our discussion exceeds the present discussion of cPGT. STUDY FUNDING/COMPETING INTEREST(S): The research for this publication was funded by the Dutch Organization for Health Research and Development (ZonMw), project number: 141111002 (Long term safety, quality and ethics of Preimplantation Genetic Diagnosis). None of the authors has any competing interests to declare.