Personalized ovarian stimulation for assisted reproductive technology: study design considerations to move from hype to added value for patients

This review addresses which aspects of patient care during assisted reproductive technology treatment could be personalized, emphasizing current evidence and relevant study design.

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Volume 109, Issue 6, Pages 968–979

Authors:

Ben W. Mol, M.D., Ph.D., Patrick M. Bossuyt, Ph.D., Sesh K. Sunkara, M.D., Juan A. Garcia Velasco, M.D., Ph.D., Christos Venetis, M.D., Ph.D., Denny Sakkas, Ph.D., Kersti Lundin, Ph.D., Carlos Simón, M.D., Ph.D., Hugh S. Taylor, M.D., Robert Wan, Ph.D., Salvatore Longobardi, M.D., Ph.D., Evelyn Cottell, Ph.D., Thomas D'Hooghe, M.D., Ph.D.

Abstract:

Although most medical treatments are designed for the average patient with a one-size-fits-all-approach, they may not benefit all. Better understanding of the function of genes, proteins, and metabolite, and of personal and environmental factors has led to a call for personalized medicine. Personalized reproductive medicine is still in its infancy, without clear guidance on treatment aspects that could be personalized and on trial design to evaluate personalized treatment effect and benefit–harm balance. While the rationale for a personalized approach often relies on retrospective analyses of large observational studies or real-world data, solid evidence of superiority of a personalized approach will come from randomized trials comparing outcomes and safety between a personalized and one-size-fits-all strategy. A more efficient, targeted randomized trial design may recruit only patients or couples for which the personalized approach would differ from the previous, standard approach. Multiple monocenter studies using the same study protocol (allowing future meta-analysis) might reduce the major center effect associated with multicenter studies. In certain cases, single-arm observational studies can generate the necessary evidence for a personalized approach. This review describes each of the main segments of patient care in assisted reproductive technologies treatment, addressing which aspects could be personalized, emphasizing current evidence and relevant study design.


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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. The journal publishes juried original scientific articles in clinical and laboratory research relevant to reproductive endocrinology, urology, andrology, physiology, immunology, genetics, contraception, and menopause. Fertility and Sterility® encourages and supports meaningful basic and clinical research, and facilitates and promotes excellence in professional education, in the field of reproductive medicine.

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