Ongoing pregnancy qualifies best as the primary outcome measure of choice in trials in reproductive medicine: an opinion paper.
The most appropriate primary outcome measure for reproductive medicine has been discussed frequently. In 2003 the European Society for Human Reproduction and Embryology recommended that the outcome measure of assisted reproductive technology (ART) and non-ART should be singleton live birth. Although live birth is indeed the aim of clinical practice, and there is no discussion that it should be reported in infertility trials, we hereby provide arguments that plead for using ongoing pregnancy as the primary outcome in such trials. We feel that ongoing pregnancy best serves the many purposes of a primary outcome and best reflects the effectiveness of a treatment.
Department of Obstetrics and Gynaecology, Centre for Reproductive Medicine, Academic Medical Centre, Amsterdam, the Netherlands. Electronic address: m.w.braakhekke@amc.nl.
Miriam
M
Braakhekke
Department of Obstetrics and Gynaecology, Centre for Reproductive Medicine, Academic Medical Centre, Amsterdam, the Netherlands.
Esme I
EI
Kamphuis
Department of Obstetrics and Gynaecology, Centre for Reproductive Medicine, Academic Medical Centre, Amsterdam, the Netherlands.
Eline A
EA
Dancet
Department of Obstetrics and Gynaecology, Centre for Reproductive Medicine, Academic Medical Centre, Amsterdam, the Netherlands.
Femke
F
Mol
Department of Obstetrics and Gynaecology, Centre for Reproductive Medicine, Academic Medical Centre, Amsterdam, the Netherlands.
Fulco
F
van der Veen
School of Paediatrics and Reproductive Health, University of Adelaide, Adelaide, South Australia, Australia.
Ben W
BW
Mol
D002755:Choice Behavior; D002986:Clinical Trials as Topic / Q000592:standards*; D005260:Female; D006801:Humans; D050498:Live Birth / Q000453:epidemiology; D011247:Pregnancy; D018873:Pregnancy Rate; D018456:Reproductive Medicine / Q000592:standards*; D027724:Reproductive Techniques, Assisted / Q000592:standards; D016896:Treatment Outcome
RCT; ongoing pregnancy; primary outcome measure; reproductive medicine; singleton outcome measure