Introduction: Endometriosis is an inflammatory estrogen-dependent gynecological disease, which is one of the common reasons for infertility. The current treatments of endometriosis-associated infertility often involve laparoscopic surgery, medical therapy and in vitro fertilization (IVF) therapy, which are expensive, and the therapeutic effects are far from the expectation. Acupuncture and Yangjing Zhongyu Decoction (YZD) which have the advantages of effective and inexpensive, have been used clinically for the infertile female in China for many years. However, a comprehensive evaluation of the current clinical evidence of their efficacy is lacking. Our study intends to evaluate the efficacy of acupuncture and YZD on endometriosis-associated infertility (EAI).
Methods/design: This study is a multi-center, controlled and randomized clinical trial. A total of 224 eligible patients with endometriosis-associated infertility will be randomly assigned into two groups, in a 1:1 ratio as the treatment group or the control group. All participants will receive pregnancy guidance. The participants assigned to the treatment group will be treated with acupuncture and YZD while the control group will receive the GnRH-a therapy. The trial will include three menstrual cycles of treatment and twelve menstrual cycles of follow-up. The primary outcome is pregnancy rate that will be verified by human chorionic gonadotropin (HCG) tests and secondary outcomes include the result of ultrasound, cancer antigen 125 (CA125), anti-Müllerian hormone (AMH), sex hormones, alanine aminotransferase (ALT) and the Endometriosis Health Profile-5 (EHP-5). Outcome will be collected at baseline, the end of treatments and follow-up visits at 3, 6 and 12 menstrual cycles. All the data including the major adverse events will be recorded in electronic case report forms and analysed by SPSS V.25.0.
Discussion: This study protocol will help to evaluate whether acupuncture and Chinese herb medicine Yangjing Zhongyu Decoction are effective in increasing pregnancy rate of the infertile female with endometriosis.
Trial registration: ChiCTR2100042830; Registered on 29 January 2021.