TY - JOUR
T1 - Personalized ovarian stimulation for assisted reproductive technology
T2 - study design considerations to move from hype to added value for patients
AU - Mol, Ben W.
AU - Bossuyt, Patrick M.
AU - Sunkara, Sesh K.
AU - Garcia Velasco, Juan A.
AU - Venetis, Christos
AU - Sakkas, Denny
AU - Lundin, Kersti
AU - Simón, Carlos
AU - Taylor, Hugh S.
AU - Wan, Robert
AU - Longobardi, Salvatore
AU - Cottell, Evelyn
AU - D'Hooghe, Thomas
PY - 2018/6/1
Y1 - 2018/6/1
N2 - 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.
AB - 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.
KW - ART
KW - Personalized medicine
KW - precision medicine
KW - trial design
UR - http://www.scopus.com/inward/record.url?scp=85048709480&partnerID=8YFLogxK
U2 - 10.1016/j.fertnstert.2018.04.037
DO - 10.1016/j.fertnstert.2018.04.037
M3 - Review Article
AN - SCOPUS:85048709480
SN - 0015-0282
VL - 109
SP - 968
EP - 979
JO - Fertility and Sterility
JF - Fertility and Sterility
IS - 6
ER -