Electro-Acupuncture for Diminished Ovarian Reserve: Protocol for a Randomized, Placebo-Controlled Trial.

INTRODUCTION

Diminished ovarian reserve (DOR) is characterized by a reduced response to ovarian stimulation and a decline in fertility potential among women of reproductive age. Although previous research has suggested potential benefits of acupuncture for DOR, the evidence remains inconclusive. This study evaluates the effectiveness of electro-acupuncture in patients with DOR by examining changes in ovarian reserve indicators and reproductive outcomes. The study aims to determine whether electro-acupuncture significantly improves ovarian reserve markers and reproductive outcomes in women with DOR, thereby informing clinical decision-making.

METHODS AND ANALYSIS

A randomized, subject- and assessor-blinded, placebo-controlled trial will be conducted in two hospitals in Shenzhen, China. A total of 112 participants (20-48 yr) will be allocated to either the electro-acupuncture (EA) group or the sham electro-acupuncture (SA) group in a 1:1 ratio. Each participant will receive 3 treatment sessions per week over a continuous period of 12 weeks. The primary outcome is the change in antral follicle count, with an anticipated mean increase of approximately 2.2 follicles based on previous meta-analytic findings. Secondary outcomes will include changes in serum basal hormone levels, serum anti-Müllerian hormone levels, and self-rating anxiety, depression, and Kupperman Index scores compared to baseline. Subgroup analyses will explore variations in pregnancy outcomes (eg, clinical pregnancy rate, live birth rate), age groups (≤32, 32-40, ≥40 years), and ovulation induction outcomes (eg, number of oocytes retrieved, MII oocyte rate). Adverse events will be recorded following each session of treatment, and a blinded evaluation is conducted upon the completion of the treatment. Study results will be primarily analyzed using the full analysis set, supplemented by the per-protocol set.

ETHICS AND DISSEMINATION

This protocol have been approved by the Ethics Committee of Shenzhen Hospital of Shanghai University of Traditional Chinese Medicine (No.2023-LHQZYYYXLL-KY-147) and Luohu People's Hospital (No.2024-LHQRMYY-KYLL-009). The results will be disseminated to participants, the public, and other relevant groups through open-access journals and conferences.

TRIAL REGISTRATION NUMBER

ISRCTN:69623204. Registered on 10 January 2024.