Integrative Management of Acupuncture for Diminished Ovarian Reserve with Insomnia: Study Protocol for a Prospective...

Insomnia, a prevalent but often overlooked comorbidity in women with diminished ovarian reserve (DOR), remains underaddressed in reproductive care. This study explores the novel integration of acupuncture as a dual-benefit intervention, aiming to simultaneously address insomnia and potentially improve fertility in DOR patients.

This single-blind randomized controlled trial (RCT) will recruit 128 DOR patients with insomnia. They will be randomly allocated to receive either verum acupuncture or sham acupuncture. The acupuncture course lasts for 12 weeks, with three sessions per week, each lasting 30 minutes, and is carried out continuously during menstruation. The primary outcome is the change in sleep quality, assessed by the Pittsburgh Sleep Quality Index (PSQI) scores. Secondary outcomes include the assessment of sleep dysfunction, anxiety and depression status, and ovarian function in DOR patients. Sleep dysfunction will be profiled using the Insomnia Severity Index (ISI) to quantify insomnia severity, whereas daytime somnolence will be assessed using the Epworth Sleepiness Scale (ESS), and daytime fatigue will be evaluated with Flinders Fatigue Scale (FFS). Circadian rhythm will be characterized using both Morningness-Eveningness Questionnaire (MEQ) and Munich Chronotype Questionnaire (MCTQ). Anxiety fluctuations will be tracked with the State-Trait Anxiety Inventory (STAI), and depressive symptomatology will be indexed using the Beck Depression Inventory (BDI). In parallel, ovarian reserve parameters will also be assessed. Safety outcomes will be systematically recorded and reported following the STRICTA-recommended framework.

This study develops an acupuncture protocol for DOR patients with insomnia, and aims to generate robust clinical evidence to support the integration of acupuncture into reproductive medicine practice.

ITMCTR2025001081.