Efficacy and Safety of Acupoint Catgut Embedding Combined with Hormone Replacement Therapy versus Sham Acupoint Embedding Combined with Hormone Replacement Therapy for Diminished Ovarian Reserve: A Single-Blind Randomized Controlled Trial.

Abstract

Introduction: To investigate the differences in efficacy between Hormone Replacement Therapy (HRT) combined with Acupoint Catgut Embedding (ACE) and HRT combined with Sham Acupoint Embedding (SAM) in patients with Diminished Ovarian Reserve (DOR).

Methods: A prospective, multicenter, randomized, single blind, controlled trial design was employed. Participants were randomly allocated to either the HRT + ACE group or the HRT + SAM group. Active treatment lasted 3 menstrual cycles, followed by 3 cycles of follow-up. Serum AMH, AFC, Ovarian volume, and serum Testosterone (T), FSH, LH, Estradiol (E2), Prolactin (PRL), and Cytokines (IL-2, IL-6, IL-17) levels were measured pre-treatment and post 3- treatment cycles and at follow-up for 3 treatment cycles.

Results: In the treatment group, after 3 treatment cycles, AMH levels increased from baseline (P < 0.05). AFC, ovarian volume, and E2 all increased significantly in both groups compared with baseline (P < 0.05). Basal FSH (bFSH), basal LH (bLH), and IL-2 levels significantly decreased in the two groups (P < 0.05). All indicators in the treatment group at both post-treatment and 3- month follow-up were significantly better than baseline (P < 0.05). The treatment group was better than the control group in terms of AMH, AFC, bFSH, bLH, and IL-2 after 3 months and 6 months follow-up (P < 0.05). No serious adverse events occurred in either group.

Discussion: This study demonstrates that HRT combined with ACE can regulate neuroendocrine function, stimulate the reproductive axis, and modulate HPO axis function to improve ovarian function. Although ACE cannot normalize ovarian function, it optimizes follicle development and menstruation. It is a promising low-risk alternative for HRT-intolerant DOR patients.

Conclusion: HRT combined with ACE can improve certain ovarian reserve indicators, including increasing AMH levels, AFC, and ovarian volume in DOR patients, with effects superior to those of HRT combined with SAM, suggesting that HRT combined with ACE may enhance ovarian function in DOR patients.