title: Equipoise and the RCT.
abstract: Clinical decisions in reproductive medicine are often made in uncertainty. To reduce uncertainty and to improve clinical decision-making, RCTs are increasingly called upon. A key concept underpinning the ethics of RCTs is equipoise. Here, we aimed to dissect the basic reasoning behind the concept of equipoise and we proposed a line of thinking delineating under which conditions it is ethical to design and execute an RCT. This might prevent a priori negative trials, reduce research waste and aid in the design of meaningful ones. It is these trials that will provide insight on how to safely and effectively assist subfertile couples.
authors.affiliation: Department of Obstetrics and Gynaecology, Centre for Reproductive Medicine, Room Q3-119, Academic Medical Centre, University of Amsterdam, Meibergdreef 9, 1105 AZ Amsterdam, the Netherlands m.w.braakhekke@amc.nl.
authors.forename: M
authors.initials: M
authors.lastname: Braakhekke
authors.affiliation: Department of Obstetrics and Gynaecology, Centre for Reproductive Medicine, Room Q3-119, Academic Medical Centre, University of Amsterdam, Meibergdreef 9, 1105 AZ Amsterdam, the Netherlands.
authors.forename: F
authors.initials: F
authors.lastname: Mol
authors.affiliation: Department of Obstetrics and Gynaecology, Centre for Reproductive Medicine, Room Q3-119, Academic Medical Centre, University of Amsterdam, Meibergdreef 9, 1105 AZ Amsterdam, the Netherlands.
authors.forename: S
authors.initials: S
authors.lastname: Mastenbroek
authors.affiliation: Robinson Research Institute, School of Paediatrics and Reproductive Health, University of Adelaide, Adelaide, SA 5000, Australia.|The South Australian Health and Medical Research Institute, Adelaide, SA 5000, Australia.
authors.forename: B Willem J
authors.initials: BW
authors.lastname: Mol
authors.affiliation: Department of Obstetrics and Gynaecology, Centre for Reproductive Medicine, Room Q3-119, Academic Medical Centre, University of Amsterdam, Meibergdreef 9, 1105 AZ Amsterdam, the Netherlands.
authors.forename: F
authors.initials: F
authors.lastname: van der Veen
mesh_terms: D000066491:Clinical Decision-Making / Q000941:ethics*; D032984:Ethics, Research; D019317:Evidence-Based Medicine; D006801:Humans; D016032:Randomized Controlled Trials as Topic / Q000941:ethics*; D018456:Reproductive Medicine / Q000941:ethics*; D035501:Uncertainty
keywords: RCT; biological plausibility; clinical decision-making; equipoise; evidence-based medicine; reproductive medicine