针刺治疗子宫内膜异位症相关性不孕:一项随机对照试验研究方案  

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

作　　者：吴楚婷 董晓燕[1] 李欣荣[2] 曹阳[1] 黄彩梅 李铭旸 胡佳玮 高源 李语然 吴焕淦[1] 张春雁[1] Chu-ting WU;Xiao-yan DONG;Xin-rong LI;Yang CAO;Cai-mei HUANG;Ming-yang LI;Jia-wei HU;Yuan GAO;Yu-ran LI;Huan-gan WU;Chun-yan ZHANG(Yueyang Hospital of Integrated Traditional Chinese and Western Medicine,Shanghai University of Traditional Chinese Medicine,Shanghai 200437,China;Obstetrics&Gynecology Hospital of Fudan University,Shanghai 200011,China;Hospital for Maternity and Child Careof Changning District,Shanghai 200051,China)

机构地区：[1]上海中医药大学附属岳阳中西医结合医院,上海200437 [2]复旦大学附属妇产科医院,上海200011 [3]上海市长宁区妇幼保健院,上海200051

出　　处：《World Journal of Acupuncture-Moxibustion》2024年第2期156-162,共7页世界针灸杂志（英文版）

基　　金：Supported by Shanghai Sailing Program:22YF1444200;the National Natural Science Foundation of China:81403429;Clinical Research Project of Shanghai Municipal Health Commission:202240054。

摘　　要：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),antiMullerian 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.

关 键 词：Endometriosis-associated infertility(EAl) ACUPUNCTURE Randomized controlled trials(RCTs) Protocol 

分 类 号：R246.3[医药卫生—针灸推拿学]