A clinical trial is currently underway at Shandong Provincial Third Hospital to investigate the potential of acupuncture in treating diminished ovarian reserve (DOR). The study, approved by the hospital's Medical Ethics Committee, aims to understand the neuroimaging mechanisms behind acupuncture's effects on ovarian function using resting-state functional MRI (rs-fMRI).
Study Design and Methods
The trial will recruit 30 women diagnosed with DOR, alongside 30 healthy female volunteers of childbearing age. DOR diagnosis is based on meeting at least two of the following criteria: AMH <1.1ng/mL, AFC less than 5–7, and bFSH ≥10U/L for two consecutive menstrual cycles. Participants will undergo unified training, and informed consent will be obtained.
The DOR group will receive acupuncture three times a week for 50 minutes each session, over three consecutive menstrual cycles. Acupoints selected include GV20 (Baihui), GV24 (Shenting), GB13 (Benshen), CV12 (Zhongwan), ST25 (Tianshu), CV4 (Guanyuan), KI12 (Dahe), ST29 (Guilai), ST36 (Zusanli), SP6 (Sanyinjiao), KI3 (Taixi), LR3 (Taichong), BL23 (Shenshu), and BL32 (Ciliao). The healthy control group will only undergo one functional magnetic resonance imaging scan.
fMRI and Data Analysis
Rs-fMRI data will be collected using a Philips Ingenia 5.0T magnetic resonance scanner. Image processing will be performed using SPM12 and DPARSF software on the Matlab R2015b platform. Functional connectivity (FC) analysis will be conducted to identify differences between DOR patients and healthy controls, as well as changes before and after acupuncture treatment.
Outcome Measures
The primary outcome indicators are FSH levels and AFC, measured before and after three months of acupuncture treatment. Secondary outcome indicators include LH, E2, and AMH values, along with assessments of symptoms and emotional status using the Modified Kupperman Scale, SAS, and SDS. Safety will be monitored by documenting any adverse events associated with acupuncture.
Significance and Potential Impact
This study seeks to provide initial insights into the neuroimaging mechanisms underlying acupuncture's efficacy in treating DOR. By analyzing brain functional connectivity, researchers aim to identify how acupuncture regulates the brain function network in DOR patients. The findings could offer valuable evidence supporting acupuncture as a therapeutic intervention for diseases related to ovarian dysfunction.
Limitations
The researchers acknowledge limitations including a small sample size and the absence of intervention in the control group, which may exaggerate the therapeutic effect of acupuncture. Additionally, the lack of a standardized definition of "health" in the control group and potential biases in the DOR diagnostic criteria are noted as potential sources of error.
