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

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

*Corresponding author for this work

Research output: Contribution to journalReview articlepeer-review

28 Citations (Scopus)
4 Downloads (Pure)


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.

Original languageEnglish
Pages (from-to)968-979
Number of pages12
JournalFertility and Sterility
Issue number6
Early online date20 Jun 2018
Publication statusPublished - Jun 2018

Data Availability Statement

Medical writing for this article funded by Merck KGaA, Darmstadt, Germany.


  • ART
  • personalized medicine
  • precision medicine
  • trial design


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