Acupuncture for endometriosis-associated infertility: Study protocol for a randomized controlled trial

Background

Acupuncture has been proven to improve the pregnancy rate in infertile women. Endometriosis is a common cause of infertility. So far, there are no studies of the efficacy of acupuncture on endometriosis-associated infertility (EAI). Therefore, we will conduct a randomized controlled trial (RCT) to investigate whether acupuncture could have higher pregnancy rates in patients with EAI compared with sham acupuncture. The study protocol is reported in this paper.

Methods/design

The current trial is a multicenter randomized controlled study undergoing in Shanghai, China. About 224 eligible patients with EAI will be randomly assigned into the acupuncture group and the sham acupuncture group in a 1:1 ratio. In the acupuncture group, patients will be treated with acupuncture on Guanyuan (CV4), Zhongji (CV3), Zigong (EX-CA1), Xuehai (SP10), Zusanli (ST36), Sanyinjiao (SP6), and Taichong (LR3), twice a week, for 3 menstrual cycles, and 12 menstrual cycles will be followed up. The Park sham device will be used to perform non-transdermal acupuncture in the sham acupuncture group. The operation points will be located at 1.5 cm away beside these acupoints in the acupuncture group. The intervention period is the same as that in the acupuncture group. The primary outcome will be pregnancy rate. Secondary outcomes will include ultrasound results, cancer antigen 125 (CA125), anti-Müllerian hormone (AMH), sex hormones, and the Endometriosis Health Profile-5 (EHP-5). Outcomes will be collected at baseline, the end of treatment, and follow-up visits at 3, 6, and 12 menstrual cycles. All data, including major adverse events, will be recorded in electronic case report forms and analyzed using SPSS V.25.0.

Discussion

This study will help to evaluate whether acupuncture is effective in increasing the pregnancy rate of infertile women with endometriosis.

Trial registration

http://www.chictr.org.cn/ Identifier: ChiCTR2100047662. Registered 21 June 2021.