Key Finding
This protocol describes a 128-patient randomized trial testing whether acupuncture can simultaneously improve both sleep quality and ovarian function in women with diminished ovarian reserve and insomnia.
Researchers are studying whether acupuncture can help women facing two challenging conditions at once: diminished ovarian reserve (DOR), which affects fertility, and insomnia. Many women with DOR struggle with sleep problems, but this issue often goes unaddressed in fertility care. This study will test whether acupuncture might improve both sleep quality and fertility markers simultaneously.
The research will involve 128 women with both DOR and insomnia. Half will receive real acupuncture, while the other half will receive sham (fake) acupuncture for comparison. Participants won't know which type they're receiving. Treatment will last 12 weeks, with three 30-minute sessions per week, continuing even during menstruation.
Researchers will measure sleep quality using the Pittsburgh Sleep Quality Index as their main outcome. They'll also track insomnia severity, daytime sleepiness, fatigue levels, natural sleep-wake patterns, anxiety, depression, and ovarian function markers. This comprehensive approach will help determine whether acupuncture provides meaningful benefits for both sleep and reproductive health.
This is a protocol paper, meaning it describes a study that is planned but hasn't yet been completed. The results aren't available yet, but once finished, this research could provide important evidence about whether acupuncture should be integrated into fertility care for women with sleep problems. The study is registered and will follow rigorous safety reporting standards.
If you're considering acupuncture for fertility or sleep concerns, seek care from a qualified, licensed acupuncturist with experience in reproductive health.
This single-blind RCT protocol aims to evaluate acupuncture's efficacy for diminished ovarian reserve (DOR) patients with comorbid insomnia, addressing a previously overlooked aspect of reproductive care. The study will randomize 128 DOR patients to receive either verum or sham acupuncture over 12 weeks (three 30-minute sessions weekly, continuous through menstruation). The primary outcome measures sleep quality via Pittsburgh Sleep Quality Index (PSQI). Secondary outcomes comprehensively assess sleep dysfunction (ISI, ESS, FFS), circadian rhythm (MEQ, MCTQ), psychological status (STAI, BDI), and ovarian reserve parameters. This protocol represents a novel dual-benefit intervention approach, simultaneously targeting insomnia and fertility outcomes in DOR patients. Safety outcomes will follow STRICTA framework reporting standards. As a protocol publication, results are pending, but the study design provides a rigorous methodology for generating clinical evidence supporting acupuncture integration into reproductive medicine practice for this underserved patient population.
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