Please use this identifier to cite or link to this item:
https://hdl.handle.net/2440/113922
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Type: | Journal article |
Title: | Personalized ovarian stimulation for assisted reproductive technology: study design considerations to move from hype to added value for patients |
Author: | Mol, B.W. Bossuyt, P.M. Sunkara, S.K. Garcia Velasco, J.A. Venetis, C. Sakkas, D. Lundin, K. Simón, C. Taylor, H.S. Wan, R. Longobardi, S. Cottell, E. D'Hooghe, T. |
Citation: | Fertility and Sterility, 2018; 109(6):968-979 |
Publisher: | Elsevier |
Issue Date: | 2018 |
ISSN: | 0015-0282 1556-5653 |
Statement of Responsibility: | Ben W.Mol, Patrick M.Bossuyt, Sesh K.Sunkara, Juan A.Garcia Velasco, Christos Venetis, Denny Sakkas ... et al. |
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. |
Keywords: | ART Personalized medicine precision medicine trial design |
Rights: | ©2018 The Authors. Published by Elsevier Inc. on behalf of the American Society for Repro- ductive Medicine. This is an open access article under the CC BY-NC-ND license (http:// creativecommons.org/licenses/by-nc-nd/ 4.0/). https://doi.org/10.1016/j.fertnstert. 2018.04.037 |
DOI: | 10.1016/j.fertnstert.2018.04.037 |
Grant ID: | http://purl.org/au-research/grants/nhmrc/1082548 http://purl.org/au-research/grants/nhmrc/1147154 |
Published version: | http://dx.doi.org/10.1016/j.fertnstert.2018.04.037 |
Appears in Collections: | Aurora harvest 8 Obstetrics and Gynaecology publications |
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hdl_113922.pdf | Published version | 183.65 kB | Adobe PDF | View/Open |
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