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Verna Jans Elementen V4.Indd From lab to fertility clinic Citation for published version (APA): Jans, V. A. A. M. (2020). From lab to fertility clinic: the welfare of the child and the ethics of introducing new reproductive technologies. Maastricht University. https://doi.org/10.26481/dis.20201111vj Document status and date: Published: 01/01/2020 DOI: 10.26481/dis.20201111vj Document Version: Publisher's PDF, also known as Version of record Please check the document version of this publication: • A submitted manuscript is the version of the article upon submission and before peer-review. There can be important differences between the submitted version and the official published version of record. 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If the publication is distributed under the terms of Article 25fa of the Dutch Copyright Act, indicated by the “Taverne” license above, please follow below link for the End User Agreement: www.umlib.nl/taverne-license Take down policy If you believe that this document breaches copyright please contact us at: [email protected] providing details and we will investigate your claim. Download date: 27 Sep. 2021 FROM LAB TO FERTILITY CLINIC The welfare of the child and the ethics of introducing new reproductive technologies Verna Jans © Verna Jans, Nijmegen 2020 Printing: ProefschriftMaken II proefschriftmaken.nl ISBN 978-94-6380-961-0 FROM LAB TO FERTILITY CLINIC The welfare of the child and the ethics of introducing new reproductive technologies PROEFSCHRIFT ter verkrijging van de graad van doctor aan de Universiteit Maastricht, op gezag van de Rector Magnificus, Prof. dr. Rianne M. Letschert volgens het besluit van het College van Decanen, in het openbaar te verdedigen op woensdag 11 november 2020 om 12.00 uur door Verna Anna Ardina Maria Jans Promotores Prof. dr. G.M.W.R. de Wert CopromotorProf. dr. W.J. Dondorp BeoordelingscommissieProf. dr. H. Mertes (Universiteit Gent) Prof. dr. J.S.M. Krumeich (voorzitter) Prof. dr. I.D. de Beaufort (Erasmus Universiteit Rotterdam) Prof. dr. A.L. Bredenoord (Universiteit Utrecht) dr. R.J.T. van Golde Prof. dr. T.E. Swierstra Deze dissertatie doet verslag van een promotieonderzoek dat onderdeel was van het Science and Ethics of stem cell derived Gametes (SEGa) project, gefinancierd door IWT (nu VLAIO), projectnummer 150042. Het onderzoek vond plaats bij de afdeling Health, Ethics and Society (HES) aan de faculteit Health, Medicine en Life sciences (FHML) van Universiteit Maastricht. Het onderzoek was ondergebracht in het programma van GROW, School for Oncology & Developmental Biology. Table of contents Chapter 1 9 Introduction Chapter 2 21 Balancing animal welfare and assisted reproduction: Ethics of preclinical animal research for testing new reproductive technologies Chapter 3 43 Of mice and human embryos: Is there an ethically preferred order of preclinical research on new assisted reproductive technologies? Chapter 4 59 Between innovation and precaution: How did offspring safety considerations play a role in strategies of introducing new reproductive techniques? Chapter 5 87 Follow-up in the field of reproductive medicine: An ethical exploration Chapter 6 107 General discussion Valorization addendum 141 Samenvatting 145 Acknowledgements 159 About the author 165 Chapter 1 Introduction 10 | Chapter 1 1. Background Assisted reproductive technologies (ARTs) are subject to constant innovation. Since the highly controversial birth of the first ‘test-tube baby’ about forty years ago, the development of new reproductive techniques increased rapidly and resulted in the dynamic whirlwind the reproductive field is today. Still, while some may say we are already ‘playing God’, innovation is far from stagnating, as new reproductive technologies swiftly keep popping up on the horizon. The constant changes in the reproductive field keep instigating a broad range of ethical questions. A first set of questions that arises concerns the moral acceptability of certain reproductive treatments. For example, is the development of a certain reproductive technique at odds with human dignity? Is a certain treatment acceptable when it possibly leads to embryo loss? And what weight should be given to the wish to have a genetic link with one’s child? Second, if a certain technique can be considered acceptable in principle, ethical dilemmas present themselves in terms of the conditions to be imposed. For example, to whom should reproductive techniques be offered (what about, for example, singles and applicants affected by a particular addiction)? Also socio-ethical questions are relevant, like should reproductive treatment be reimbursed? Although all of these questions are important to investigate, this thesis will focus on a set of ethical questions concerning how to responsibly deal with medical risks of new reproductive technologies for children thus conceived. In some fields of medicine, such as the development of drugs, innovation occurs in the context of a strictly regulated system. Here, safety measures are in place in order to protect patients from being exposed to drugs of which the safety and effectiveness is insufficiently proven. In other fields of medicine, however, such as surgical medicine and medically assisted reproduction (MAR), there is no such strictly regulated system. Here, new techniques are often introduced on a basis of trial-and-error, outside a formal research context (Geraedts & de Wert, 2009; Harper et. al., 2012; Margo, 2001). This is especially worrisome in the case of MAR, as ‘safety’ does not only concern the health and wellbeing of those undergoing the procedures (mostly women), but also that of any children born as a result from these procedures (Pennings et. al., 2007). Introduction | 11 Although follow-up research has shown that up until now, only few adverse health effects of new ARTs have emerged, this should not b e taken as a reason for complacency, particularly with new reproductive technologies on the horizon that appear to come with potentially significant risks for the offspring. One of such new techniques on the horizon is the reproductive use of stem cell-derived (SCD) gametes (Cyranoski, 2016; K. Hayashi et. al., 2012; K. Hayashi et. al., 2011; Hayashi & Saitou, 2013; Hikabe et. al., 2016; Marques-Mari et. 1 al., 2009; Zhou et. al., 2016). In the context of this development, the Science and Ethics of SCD Gametes (SEGa) project was founded; a Flemish-Dutch multidisciplinary project aiming at both the scientific development of SCD gametes and timely ethical reflection on both the technique itself and its potential responsible introduction. The first part of this ethical reflection (considering the acceptability of relevant reproductive techniques itself) was performed by Seppe Segers, a member of the ethics team at Ghent University (Segers, 2019). This thesis, concerning the ethics of responsible innovation of MAR, forms the second part of the Ethics Section of this SEGa-project. There are two potential pathways to create patient-specific SCD gametes for reproductive purposes; 1) by creating an embryo via stem cell nuclear transfer (SCNT) and differentiating the embryonic stem cells (ESCs) into gametes, or 2) by creating induced pluripotent stem cells (iPSCs) and deriving gametes from these (Hendriks et. al., 2015). For both routes, a somatic cell can be used from the patient, which could in turn be differentiated into a gamete and thereafter used to fertilize the gamete of the partner. If safe and effective, the future reproductive use of SCD gametes would make it possible to better treat several forms of infertility and would thus make donor conception redundant. Using SCD gametes may, for example, enable men with azoospermia, women with primary ovarian insufficiency, people who have had gametotoxic treatments, ageing women with poor quality oocytes and poor responders in IV F programs to produce genetically related offspring. Additionally, if some serious technical challenges could be overcome, it could give same-sex couples a method to create children of which they are both a biological parent. For example, in a case of an all-male couple, SCD oocytes could be created from pluripotent cells from one of the men. The SCD oocyte could thereafter be fertilized by the naturally conceived 12 | Chapter 1 sperm cell from the other man. However, this is more complicated than with heterosexual couples, because the derivation of oocytes from an XY stem line (male) or, even more complicated, sperm from an XX stem line (female), i s more likely to have chromosomal. problems than derivation of a sex cell from
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