Study Protocol for a Randomized Controlled Trial: Evaluating the Impact of Acupuncture on Menstrual Regulation and Pregnancy Enhancement in Patients with DOR Using Rs-fMRI to Assess Brain Functional Networks

Tianyu Bai; E Zhou; Kai Wang; Weizheng Li; Jieyu Bi; Jiacheng Ju

doi:10.2147/JMDH.S490162

Study Protocol for a Randomized Controlled Trial: Evaluating the Impact of Acupuncture on Menstrual Regulation and Pregnancy Enhancement in Patients with DOR Using Rs-fMRI to Assess Brain Functional Networks

J Multidiscip Healthc. 2024 Nov 20:17:5425-5434. doi: 10.2147/JMDH.S490162. eCollection 2024.

Authors

Tianyu Bai^#¹, E Zhou^#¹, Kai Wang¹, Weizheng Li¹, Jieyu Bi¹, Jiacheng Ju¹

Affiliation

¹ Department of Acupuncture and Moxibustion, Shandong Provincial Third Hospital Shandong University, Jinan, Shandong, 250031, People's Republic of China.

^# Contributed equally.

Abstract

Background: Resting-state functional magnetic resonance imaging (rs-fMRI) is a noninvasive way to evaluate brain physiological activity by detecting blood oxygen level fluctuations. Diminished ovarian reserve (DOR) indicates ovarian aging. Before 40, patients may have menstrual abnormalities, poor reproduction, and poor assisted reproductive results. Without treatment, it can cause early ovarian failure. Studies have shown that acupuncture can ameliorate sex hormones and antral follicle count (AFC) in DOR patients.

Objective: Despite limited studies on its mechanism, acupuncture have been shown to treat DOR. There is no relevant research on brain functional magnetic resonance and brain functional connectivity of acupuncture in treating DOR. We design this clinical trial to preliminarily elucidate the neuroimaging method of controlling the brain functional network and acupuncture impact in DOR patients using rs-fMRI.

Methods: This study will involve 30 DOR patients and 30 healthy individuals. DOR patients will have rs-fMRI before and after 3 menstrual cycles of acupuncture, whereas healthy individuals will need one rs-fMRI scan. The primary end measures will be follicle-stimulating hormone (FSH) and AFC. In contrast, the secondary outcomes will be luteinizing hormone(LH), estradiol (E2), anti-Müllerian hormone (AMH), modified Kupperman scale, self-rating anxiety scale (SAS), self-rating depression scale (SDS), and rs-fMRI alterations.

Results: This study uses rs-fMRI technology to identify the brain regions that differ between DOR patients and healthy people before and after acupuncture treatment. This study will connect brain regions, examine the effects of acupuncture on menstruation and pregnancy on DOR patients' brain function networks, and discuss neuroimaging methods.

Conclusion: Acupuncture may have the potential to regulate menstruation and increase the chances of pregnancy promotion in patients with DOR.

Keywords: DOR; acupuncture; brain functional networks; clinical trials; rs-fMRI; study protocol.

Grants and funding

This study was supported by Shandong Province Natural Science Foundation Joint Fund Project (No. ZR2022LZY008), Shandong Province Chinese Medicine High-level Talent Cultivation Project (Lu Wei Talent No. [2021] 6), Shandong Province Chinese Medicine Science and Technology Project (No. B-2022002), Jinan Science and Technology Bureau Clinical Medicine Science and Technology Innovation Programme Project (No. 202225059), Qilu Health and Health Outstanding Young Talent Cultivation Project (Lu Wei Talent No. [2020] 3).