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Fertil Steril. 2018 Jun;109(6):968-979. doi: 10.1016/j.fertnstert.2018.04.037.

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

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Monash University, Clayton, Victoria, Australia.
University of Amsterdam, Amsterdam, the Netherlands.
Queen's Hospital, Barking, Havering and Redbridge University Hospitals, Essex, United Kingdom.
IVI RMA Madrid and Rey Juan Carlos University, Madrid, Spain.
University of New South Wales, Sydney, New South Wales, Australia.
Boston IVF, Waltham, Massachusetts.
Sahlgrenska University Hospital, Goteborg, Sweden.
Igenomix, Valencia University, Valencia, Spain.
Yale University Medical School, New Haven, Connecticut.
EMD Serono, Billerica, Massachusetts.
Global Medical Affairs Fertility, Research and Development, Merck KGaA, Darmstadt, Germany.
Global Medical Affairs Fertility, Research and Development, Merck KGaA, Darmstadt, Germany; Research Group Reproductive Medicine, Department of Development and Regeneration, Organ Systems, Group Biomedical Sciences, KU Leuven (University of Leuven), Leuven, Belgium; Department of Obstetrics and Gynecology, Yale University, New Haven, Connecticut. Electronic address:


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.


ART; Personalized medicine; precision medicine; trial design

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