Acupuncture on the Conception Vessel for Diminished ovarian reserve: A Multi-Center Randomized Controlled Trial Protocol

Background : Diminished ovarian reserve (DOR) is characterized by a decrease in the number and/or quality of oocytes, leading to insufficient ovarian reserve function. Currently, there is no unified treatment protocol for DOR either domestically or internationally. However, acupuncture, as a non-pharmacological therapy, has been shown in several studies to significantly improve ovarian function in patients with DOR and to maintain the balance of serum and endocrine hormones. This study aims to explore the effects of acupuncture on the Conception Vessel in improving clinical symptoms in patients with DOR, with the goal of providing higher-level evidence-based support. Methods : From November 2024 to October 2025, four hospitals in China will recruit 252 patients diagnosed with DOR to undergo acupuncture treatment. Eligible patients must meet the diagnostic criteria for DOR, be between the ages of 20 and 45, and provide informed consent. Participants will be randomly assigned in a 1:1:1 ratio to one of three groups: the Conception Vessel acupuncture group, the non-Conception Vessel acupoint group, or the Non-acupoint sham-acupuncture group, with 84 patients in each group. All patients will receive treatment three times per week for a total of 12 weeks, with a 4-week follow-up period after treatment completion. No treatment will be administered during menstruation. The primary outcome measure is the baseline antral follicle count (AFC), with comparisons made between the changes in bilateral ovarian AFC from baseline to 12 weeks after treatment, assessed via gynecological ultrasound on days 2-4 of the menstrual cycle. Expected Results and Conclusion: This study aims to further investigate an optimized treatment protocol through a prospective, sham-controlled, multicenter randomized controlled trial (RCT) design, based on real-world clinical settings. The goal is to provide new clinical insights and high-level evidence for the use of Conception Vessel acupuncture in treating DOR. Trial Registration: International Traditional Medicine Clinical Trial Registry, ITMCTR2024000882 Registered on 28 December 2024.