Acupuncture for Premature Ovarian Insufficiency: A Randomized, Non-Inferiority Protocol with Exploratory Epigenetics...

Area of Science:

• Reproductive Endocrinology
• Integrative Medicine
• Epigenetics

Background:

• Premature ovarian insufficiency (POI) affects women before age 40, impairing fertility.
• Hormone Replacement Therapy (HRT) is standard but has limitations.
• Acupuncture shows promise for POI, but lacks robust evidence and mechanistic understanding.

Purpose of the Study:

• To evaluate if acupuncture is non-inferior to HRT in improving clinical pregnancy rates for women with POI.
• To explore potential epigenetic mechanisms, specifically DNA methylation, underlying POI treatment.
• To provide clinical evidence for acupuncture as an alternative or adjunct therapy for POI.

Main Methods:

• A randomized, controlled, non-inferiority trial involving 572 women with POI undergoing assisted reproductive technology (ART).
• Participants were randomized to receive either acupuncture or HRT.
• Epigenetic analysis included whole-genome bisulfite sequencing (WGBS) on granulosa cells from 286 women.

Main Results:

• The primary outcome is the clinical pregnancy rate.
• Secondary outcomes include hormone levels, ovarian reserve markers, and DNA methylation profiles.
• The study aims to establish non-inferiority of acupuncture versus HRT.

Conclusions:

• This trial will provide crucial data on acupuncture's efficacy for POI.
• Findings may reveal DNA methylation as a key regulatory pathway in POI.
• The study seeks to advance treatment options for women with premature ovarian insufficiency.