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

Chuting Wu, Xiao-yan DONG, Xin-rong LI, Yang Cao, Cai-mei HUANG, Mingyang Li, Jiawei Hu, Yuan Gao, Yu-ran LI, Huangan Wu, Chunyan Zhang
In: World Journal of Acupuncture - Moxibustion · 2024 · vol. 34(2) , pp. 156–162 · doi:10.1016/j.wjam.2024.01.001 · W4400182565
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This randomized controlled trial protocol describes investigating whether acupuncture improves pregnancy rates in women with endometriosis-associated infertility compared to sham acupuncture.

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Abstract

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. 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. This study will help to evaluate whether acupuncture is effective in increasing the pregnancy rate of infertile women with endometriosis. http://www.chictr.org.cn/ Identifier: ChiCTR2100047662. Registered 21 June 2021.

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Outcome instruments

EHP-30

Condition tags

endometriosisinfertility

Citation neighborhood (2-hop)

Papers in the corpus that this work cites (lower rings, blue) and that cite this one (upper rings, green). Dot size scales with the paper's in-corpus citation count — bigger dot = more influential within the endo/adeno field. Click a dot to open that paper. Outer rings show 2-hop neighbours — papers reached through the immediate citers/citees. [ collapse to 1-hop ]

References (33)

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