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Acupuncture for ovulation induction in polycystic ovary syndrome: study protocol for a multicenter; randomized; sham-controlled trial
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DOI：10.3389/fendo.2026.1893429.png)
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Abstract
En 中文
IntroductionPolycystic 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.Methods and analysisThis 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.Systematic Review registrationhttps://itmctr.ccebtcm.org.cn/mgt/project/; identifier ITMCTR2025000078
Keywords:
acupuncture
polycystic ovary syndrome
randomized controlled trial
study protocol
sham acupuncture
ovulation induction
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