Effect of preconceptional DHEA treatment on in vitro fertilization outcome in poor ovarian respond women: study protocol for a randomized controlled trial

BACKGROUND: Women undergoing in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) with poor ovarian respond (POR) always have very low clinical pregnancy rates. In previous data, dehydroepiandrosterone (DHEA) was suggested as a promising treatment and maybe has a good pregnancy outcome. But there is no sufficient evidence from randomized clinical trials evaluating the effect of DHEA preconceptional treatment on live birth in POR. METHODS: This trial is a multicenter active-placebo double-blind clinical trial (1:1 treatment ratio of active versus placebo). The infertile POR patients undergoing IVF or ICSI will be enrolled and randomly assigned to two parallel groups. Participants in these two groups will be given 4–12 weeks’ treatment of DHEA or placebo, respectively. The primary outcome is live birth rate. DISCUSSION: The results of this study will provide evidence for the effect of preconceptional DHEA treatment on IVF outcome in POR. TRIAL REGISTRATION: Chinese Clinical Trial Registry, ChiCTR-IPR-15006909. Registered on November 9, 2015. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s13063-018-3146-x) contains supplementary material, which is available to authorized users.