Live birth is the correct outcome for clinical trials evaluating therapy for the infertile couple.
Well-designed and -conducted clinical trials are needed to further advance the field for reproductive medicine. However, current reporting of outcomes of trials is ambiguous and disparate. In this review it is offered that the preferred outcome for clinical trials in reproductive medicine should be live birth. Multiple births should be listed, and it should be specified whether this is multiple births per couple or multiple births per conception. The unit of measure should be women (or couples) and not cycles. The duration of exposure should also be clearly identified (i.e., treatment was one cycle, a prespecified number of cycles, or a period of time). Pregnancy loss should be specified, and the denominator should be those who conceived. Although live birth is the primary outcome, complications should be defined and reported, including multiple births and other objective markers, such as preterm delivery, small-for-gestational age, or stillbirth.
Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania. Electronic address: kbarnhart@obgyn.upenn.edu.
Kurt T
KT
Barnhart
D002986:Clinical Trials as Topic / Q000592:standards*; D005191:Family Characteristics; D005260:Female; D006801:Humans; D007231:Infant, Newborn; D007246:Infertility / Q000453:epidemiology / Q000628:therapy*; D050498:Live Birth / Q000453:epidemiology; D008297:Male; D011247:Pregnancy; D018456:Reproductive Medicine / Q000592:standards; D016896:Treatment Outcome
Infertility; clinical trial; live birth; outcome