Efficacy of electroacupuncture versus transcutaneous electrical acupoints stimulation on subclinical premature ovarian insufficiency: study protocol for a randomized controlled trial

Abstract

Introduction: "Subclinical stage" of premature ovarian insufficiency (POI) refers to menstrual disorders with FSH levels in the range of 15-25 U/L in women under 40 years old caused by diminished ovarian function. Early intervention of subclinical POI may be able to protect ovarian function more effectively and prevent further development to POI. Currently, no standard-of-care exists for subclinical POI. Previous studies have shown effectiveness of electroacupuncture (EA) on POI and transcutaneous electrical acupoint stimulation (TEAS) on diminished ovarian reserve, but no published studies focus on the treatment of subclinical POI. This study aims to assess whether EA or TEAS will be effective in improving ovarian function at the subclinical stage of POI and preventing the progression. Methods: 114 subclinical POI patients between 25 and 40 years will be randomly assigned to three groups (an EA group, a TEAS group and a waiting for treatment group) in this randomized, controlled, assessor-blinded trial. The treatment will last for three months and the follow-up will last for twelve months. The primary outcomes will be anti-Mullerian hormone (AMH) and follicle-stimulating hormone (FSH). Secondary outcomes will include serum estradiol (E2), luteinizing hormone (LH), FSH/LH ratio, the menstrual status assessment, and modified Kupperman Menopausal Index. We will also investigate the incidence of adverse events. Trial registration: Trial was registered in the Chinese Clinical Trail Registry (ChiCTR-2100045598); Pre-results.