Acupuncture for ovulation induction in polycystic ovary syndrome: study protocol for a multicenter, randomized,...

Polycystic ovary syndrome (PCOS) is a common endocrine disorder affecting up to 15% of reproductive-aged women, and is characterized by chronic anovulation that leads to irregular menstrual cycles, infertility, and long-term health risks. While acupuncture has been used for ovulation induction in PCOS, existing evidence remains inconclusive due to methodological limitations and clinical heterogeneity of enrolled populations, which have been largely overlooked. This trial aims to evaluate the efficacy of manual acupuncture for improving ovulation in a precisely defined, more homogeneous PCOS subgroup.

This is a prospective, multicenter, randomized, sham-controlled trial. A total of 156 participants with PCOS will be randomly assigned at a 1:1 ratio to receive either manual acupuncture (MA) or sham acupuncture (SA). Eligible participants present with spontaneous menstrual cycles lasting 35-60 days and a body mass index (BMI) below 28.0 kg/m², and this trial targets a subgroup of patients with mild-to-moderate ovulatory dysfunction. The intervention lasts 12 weeks and comprises 36 treatment sessions (three sessions weekly), after which participants will enter a 12-week follow-up phase. The primary outcome is the cycle ovulation rate (COR) at Week 12, verified via transvaginal ultrasound. Secondary outcomes include menstrual cycle characteristics, reproductive hormone profile, metabolic parameters, anthropometric measures, quality of life, anxiety and depression, patient global impression of change, and safety outcomes. Intention-to-treat analysis will be performed, and a p-value <0.05 (two-sided) will be defined as the threshold for statistical significance.

https://itmctr.ccebtcm.org.cn/mgt/project/, identifier ITMCTR2025000078.