Abstract
Background
Diminished ovarian reserve (DOR) is characterized by decreased female fertility, menstrual disorders and perimenopausal symptoms due to sex hormone deficiency or fluctuations. For now, there are no uniform diagnostic criteria or an ideal single detection index for DOR. Acupuncture has been extensively used to treat female infertility. This study is aim to discover the biological characteristics of the DOR-related acupoints and explore the efficacy of intradermal acupuncture treatment on DOR patients.
Methods/design:
To discover which acupoints are associated with DOR,there will be 50 DOR patients and 50 healthy participants included to detect the biological characteristics of certain acupoints. The primary outcome will be pain threshold and infrared thermal temperature. In the following randomized controlled trial, 106 patients with DOR will be randomly divided into intradermal acupuncture or sham intradermal acupuncture in a 1:1 ratio to achieve treatment for 12 weeks. The primary outcomes will be the changes in serum follicle-stimulating hormone(FSH) and Anti-Müllerian Hormone (AMH) level from baseline to the end of treatment(week 12). the secondary outcomes include the changes of biological characteristics of treated acupoints, the modified Kupperman Index (KI), Self-Rating Anxiety Scale (SAS) and Self-rating Depression Scale (SDS).
Discussion
The purpose of this study is to observe whether there is regularity in the biological characteristics of meridian points under the disease state, and consider these changes as an auxiliary detection means for DOR diagnosis. It also helps to screen out DOR-sensitive acupoints as a reference for treatment selection, and is expected to explore the efficacy of intradermal acupuncture and sham intradermal acupuncture in treating DOR.
Trial registration:
Registered in ClinicalTrials.gov NCT06395623(Registered on 3 may, 2024), NCT06223178(Registered on 28 January, 2024)