Acupuncture And Chinese Herb Medicine Yangjing Zhongyu Decoction For The Treatment of Endometriosis-Associated Infertility: A Study Protocol For A Multi-Center, Controlled and Randomized Clinical Trial

In: Research Square · 2021 · doi:10.21203/rs.3.rs-402051/v1 · W3182842095
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This multi-center randomized controlled trial will evaluate the efficacy of acupuncture and Yangjing Zhongyu Decoction compared to GnRH-a therapy for endometriosis-associated infertility, measuring pregnancy rates and other health markers.

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This paper is a study protocol for a multi-center, controlled, randomized clinical trial evaluating whether acupuncture combined with Yangjing Zhongyu Decoction (YZD) can improve pregnancy outcomes in 224 patients with endometriosis-associated infertility. Participants receive “pregnancy guidance” and are randomized 1:1: the treatment group gets acupuncture plus YZD, while the control group receives GnRH-a therapy, with treatment over three menstrual cycles and follow-up for 12 cycles; primary outcome is pregnancy rate confirmed by hCG testing, with secondary outcomes including ultrasound findings, CA125, AMH, sex hormones, ALT, and the Endometriosis Health Profile-5 (EHP-5). A stated limitation is that the report is a protocol/preprint and therefore does not provide results. This paper is centrally about endometriosis — it details a randomized trial protocol of acupuncture and Yangjing Zhongyu Decoction for endometriosis-associated infertility.

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Abstract

Abstract 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.
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Acupuncture And Chinese Herb Medicine Yangjing Zhongyu Decoction For The Treatment of Endometriosis-Associated Infertility: A Study Protocol For A Multi-Center, Controlled and Randomized Clinical Trial | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Acupuncture And Chinese Herb Medicine Yangjing Zhongyu Decoction For The Treatment of Endometriosis-Associated Infertility: A Study Protocol For A Multi-Center, Controlled and Randomized Clinical Trial Chuting Wu, Xiaoyun Zhang, Chunyan Zhang This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-402051/v1 This work is licensed under a CC BY 4.0 License Status: Under Review Version 1 posted 4 You are reading this latest preprint version Abstract 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. Translational Medicine Internal Medicine Integrative & Complementary Medicine endometriosis infertility Traditional Chinese Medicine Chinese herbal medicine acupuncture Yangjing Zhongyu Decoction Figures Figure 1 Full Text Supplementary Files SPIRITchecklist.pdf APPENDIX12.pdf Cite Share Download PDF Status: Under Review Version 1 posted Reviews received at journal 22 May, 2021 Reviewers invited by journal 21 May, 2021 Editor assigned by journal 05 May, 2021 First submitted to journal 06 Apr, 2021 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. 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