Methodological issues in randomized clinical trials in reproductive medicine

This article discusses novel methodologic aspects of randomized clinical trials.

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Volume 113, Issue 6, Pages 1107–1112


Christos Venetis, Ph.D., Thomas d’Hooghe, Ph.D., Kurt T. Barnhart, M.D., MSCE, Patrick M.M. Bossuyt, Ph.D., Ben Willem J. Mol, Ph.D.


Randomized controlled trials (RCTs) are the cornerstone of evidence-based medicine. In this series in Fertility and Sterility, several aspects of RCTs are discussed, with contributions on multicenter RCTs, different international settings, and integrity of RCTs. The present contribution deals with methodologic issues. We discuss different types of RCTs based on null hypothesis (superiority vs. noninferiority vs. equivalence) as well as frequentist versus Bayesian interpretation. We also discuss the use of RCTs in the era of personalized medicine and RCTs to address diagnostic and prognostic questions. Finally, we address the use of big data compared with the use of RCTs.

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Fertility and Sterility

Editorial Office, American Society for Reproductive Medicine

Fertility and Sterility® is an international journal for obstetricians, gynecologists, reproductive endocrinologists, urologists, basic scientists and others who treat and investigate problems of infertility and human reproductive disorders.