Exploring the efficacy and safety of acupuncture versus sham acupuncture for diminished ovarian reserve: study protocol for a multicentre randomised controlled trial

Abstract

IntroductionThe therapeutic needs of women with diminished ovarian reserve (DOR), coupled with the increasing application of acupuncture in improving ovarian function, have highlighted the need to verify the efficacy and safety of acupuncture for DOR. This study aims to provide high-quality evidence by evaluating both ovarian reserve and in vitro fertilisation (IVF) outcomes.Methods and analysisA large-scale, multicentre, randomised controlled trial will be carried out across seven hospitals in China. 400 women with DOR will be randomised in a 1:1 ratio to an acupuncture group or a sham acupuncture group. Acupuncture or sham acupuncture will consist of 36 sessions per participant over 12 weeks. The primary outcome will be the change in antral follicle count (AFC) at week 12 from baseline. Secondary outcomes are AFC at week 24, the serum levels of basal follicle-stimulating hormone and anti-Mullerian hormone at weeks 12 and 24, the scores of the Self-Rating Anxiety Scale at weeks 12 and 24, clinical pregnancy rate, and IVF embryo transfer related outcomes. Any adverse events during treatment will be documented.Ethics and disseminationThe study protocol has been approved by all the participating institutions. Written informed consent will be obtained prior to participant enrolment. The results of this study will be published in peer-reviewed publications.Trial registration numberChiCTR2200062295Protocol versionV2.0-20220317