Clinical efficacy and mechanism exploration of Moxibustion for diminished ovarian reserve: a randomized controlled trial protocol

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Background: Diminished ovarian reserve (DOR) is a condition that severely impacts female fertility, and there are currently no effective treatment strategies for DOR. Moxibustion may offer a non-invasive, low-risk intervention. This study aims to assess the clinical efficacy of moxibustion in improving ovarian reserve in women with DOR and to explore its underlying central neural mechanisms using resting-state functional magnetic resonance imaging. Methods: This prospective, single-center, parallel-group randomized controlled trial will be conducted at the Hubei Provincial Hospital of Traditional Chinese Medicine. Participants diagnosed with DOR will be randomly assigned in a 1:1 ratio to either an intervention group or a control group. They will both receive a lifestyle intervention. In addition, the intervention group will receive 16-week Yin-Yang Regulating Moxibustion. The primary outcome include changes in antral follicle count. Secondary outcomes include serum levels of anti-Müllerian hormone, follicle-stimulating hormone, and luteinizing hormonechanges in menopausal symptoms, anxiety, depression, and quality of life. Rs-fMRI will be used to investigate the brain's central neural mechanisms. Discussion: The results of this study will provide new insights into the adjunctive treatment of DOR and elucidate its potential mechanisms through neuroimaging. Clinical trial registration: https://itmctr.ccebtcm.org.cn/, identifier ITMCTR2025001808.