Efficacy of Acupuncture for Diminished Ovarian Reserve: A Randomized Controlled Trial Protocol.

Background: With diminished ovarian reserve (DOR) becoming increasingly younger in women, age-related fertility decline in females is gradually becoming one of the most important factors affecting female fertility. The purpose of the study is to assess whether acupuncture can successfully relieve the age-related decline in female fertility. This will provide substantial proof in support of the therapeutic effectiveness of acupuncture.

Methods: This is a randomized, double-blind, controlled trial. There will be 108 participants diagnosed with DOR recruited in China. Participants will be randomly assigned in a 1:1 ratio to two groups, including acupuncture and sham acupuncture groups. The participants will receive acupuncture treatments three times a week, each lasting 30 minutes, for 36 weeks. The primary outcome was the change in ovarian function modeling as assessed by four metrics: age, ovarian reserve markers such as follicle-stimulating hormone (FSH) and anti-Müllerian hormone (AMH) in the Ovarian Reserve Function Prediction Tool (OvaRePred). Secondary outcomes will include changes in the antral follicle count (AFC), serum sex hormone levels, Zung's Self-rating Anxiety Scale (SAS), and the Self-rating Depression Scale (SDS). Adverse events (AEs) associated with acupuncture will be documented following each treatment session. AEs will be monitored and reported to ensure patient safety throughout the trial.

Expected results and conclusion: We will be able to measure the effectiveness of acupuncture for patients with DOR and whether acupuncture is superior to sham acupuncture. The proposed acupuncture treatment might provide an alternative option for those patients.

Trial registration number: ChiCTR2400086376.