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 tria...
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| Format: | Article |
| Language: | English |
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KeAi Communications Co., Ltd.
2024-04-01
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| Series: | World Journal of Acupuncture - Moxibustion |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S1003525724000102 |
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| author | 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 |
| author_facet | 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 |
| author_sort | Chu-ting WU |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-8b565735ecbf406c9c420ef79a584580 |
| institution | DOAJ |
| issn | 1003-5257 |
| language | English |
| publishDate | 2024-04-01 |
| publisher | KeAi Communications Co., Ltd. |
| record_format | Article |
| series | World Journal of Acupuncture - Moxibustion |
| spelling | doaj-art-8b565735ecbf406c9c420ef79a5845802025-08-20T02:50:48ZengKeAi Communications Co., Ltd.World Journal of Acupuncture - Moxibustion1003-52572024-04-0134215616210.1016/j.wjam.2024.01.001Acupuncture for endometriosis-associated infertility: Study protocol for a randomized controlled trialChu-ting WU0Xiao-yan DONG1Xin-rong LI2Yang CAO3Cai-mei HUANG4Ming-yang LI5Jia-wei HU6Yuan GAO7Yu-ran LI8Huan-gan WU9Chun-yan ZHANG10Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai 200437, China (上海中医药大学附属岳阳中西医结合医院, 上海200437, 中国)Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai 200437, China (上海中医药大学附属岳阳中西医结合医院, 上海200437, 中国)Obstetrics & Gynecology Hospital of Fudan University, Shanghai 200011, China (复旦大学附属妇产科医院, 上海200011, 中国)Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai 200437, China (上海中医药大学附属岳阳中西医结合医院, 上海200437, 中国)Hospital for Maternity and Child Care of Changning District, Shanghai 200051, China (上海市长宁区妇幼保健院, 上海200051, 中国)Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai 200437, China (上海中医药大学附属岳阳中西医结合医院, 上海200437, 中国)Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai 200437, China (上海中医药大学附属岳阳中西医结合医院, 上海200437, 中国)Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai 200437, China (上海中医药大学附属岳阳中西医结合医院, 上海200437, 中国)Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai 200437, China (上海中医药大学附属岳阳中西医结合医院, 上海200437, 中国)Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai 200437, China (上海中医药大学附属岳阳中西医结合医院, 上海200437, 中国); Corresponding authors.Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai 200437, China (上海中医药大学附属岳阳中西医结合医院, 上海200437, 中国); Corresponding authors.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.http://www.sciencedirect.com/science/article/pii/S1003525724000102Endometriosis-associated infertility (EAI)AcupunctureRandomized controlled trials (RCTs)Protocol |
| spellingShingle | 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 Acupuncture for endometriosis-associated infertility: Study protocol for a randomized controlled trial World Journal of Acupuncture - Moxibustion Endometriosis-associated infertility (EAI) Acupuncture Randomized controlled trials (RCTs) Protocol |
| title | Acupuncture for endometriosis-associated infertility: Study protocol for a randomized controlled trial |
| title_full | Acupuncture for endometriosis-associated infertility: Study protocol for a randomized controlled trial |
| title_fullStr | Acupuncture for endometriosis-associated infertility: Study protocol for a randomized controlled trial |
| title_full_unstemmed | Acupuncture for endometriosis-associated infertility: Study protocol for a randomized controlled trial |
| title_short | Acupuncture for endometriosis-associated infertility: Study protocol for a randomized controlled trial |
| title_sort | acupuncture for endometriosis associated infertility study protocol for a randomized controlled trial |
| topic | Endometriosis-associated infertility (EAI) Acupuncture Randomized controlled trials (RCTs) Protocol |
| url | http://www.sciencedirect.com/science/article/pii/S1003525724000102 |
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