Cargando…

Effectiveness of electroacupuncture for thin endometrium in infertile women: study protocol for a single-blind, randomized controlled trial

BACKGROUND: Thin endometrium negatively impacts the reproductive function. Current treatments for thin endometrium do not always improve endometrial receptivity. Preliminary evidence suggests that electroacupuncture could have potential therapy for thin endometrium in infertile women. Thus, this ran...

Descripción completa

Detalles Bibliográficos
Autores principales: Li, Fangyuan, Lu, Hua, Wang, Xinxin, Zhang, Qi, Liu, Qianchen, Wang, Tong
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7818916/
https://www.ncbi.nlm.nih.gov/pubmed/33478562
http://dx.doi.org/10.1186/s13063-021-05029-7
_version_ 1783638937226444800
author Li, Fangyuan
Lu, Hua
Wang, Xinxin
Zhang, Qi
Liu, Qianchen
Wang, Tong
author_facet Li, Fangyuan
Lu, Hua
Wang, Xinxin
Zhang, Qi
Liu, Qianchen
Wang, Tong
author_sort Li, Fangyuan
collection PubMed
description BACKGROUND: Thin endometrium negatively impacts the reproductive function. Current treatments for thin endometrium do not always improve endometrial receptivity. Preliminary evidence suggests that electroacupuncture could have potential therapy for thin endometrium in infertile women. Thus, this randomized controlled trial was designed to test whether electroacupuncture can improve endometrial receptivity in infertile women with thin endometrium. METHODS: This study is a randomized, single-blinded, controlled, clinical trial. A total of 142 eligible patients will be recruited and randomly assigned to the electroacupuncture (EA) group or the sham electroacupuncture (SEA) group in a 1:1 ratio. Participants will receive 36 sessions over three menstrual cycles (12 weeks in total), with the same acupoint prescription. The primary outcome of this trial is endometrial thickness in the midluteal phase. The secondary outcomes include endometrial pattern, resistance index (RI) and pulsatility index (PI) of bilateral uterine artery and endometrium blood flow, serum estradiol (E2) and progesterone (P), and pregnancy rate. The pregnancy rate will be evaluated during a 6-month follow-up after completion of the trial. All other outcomes will be evaluated before treatment, during the treatment of 1st, 2nd, and 3rd menstrual cycle, and 6 months after treatment. DISCUSSION: If the outcome confirms the effectiveness of electroacupuncture for thin endometrium in infertile women, this treatment will be proposed for application in clinical practice. TRIAL REGISTRATION: Chinese Clinical Trials Registry ChiCTR2000029983. Registered on 18 February 2020 SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-021-05029-7.
format Online
Article
Text
id pubmed-7818916
institution National Center for Biotechnology Information
language English
publishDate 2021
publisher BioMed Central
record_format MEDLINE/PubMed
spelling pubmed-78189162021-01-22 Effectiveness of electroacupuncture for thin endometrium in infertile women: study protocol for a single-blind, randomized controlled trial Li, Fangyuan Lu, Hua Wang, Xinxin Zhang, Qi Liu, Qianchen Wang, Tong Trials Study Protocol BACKGROUND: Thin endometrium negatively impacts the reproductive function. Current treatments for thin endometrium do not always improve endometrial receptivity. Preliminary evidence suggests that electroacupuncture could have potential therapy for thin endometrium in infertile women. Thus, this randomized controlled trial was designed to test whether electroacupuncture can improve endometrial receptivity in infertile women with thin endometrium. METHODS: This study is a randomized, single-blinded, controlled, clinical trial. A total of 142 eligible patients will be recruited and randomly assigned to the electroacupuncture (EA) group or the sham electroacupuncture (SEA) group in a 1:1 ratio. Participants will receive 36 sessions over three menstrual cycles (12 weeks in total), with the same acupoint prescription. The primary outcome of this trial is endometrial thickness in the midluteal phase. The secondary outcomes include endometrial pattern, resistance index (RI) and pulsatility index (PI) of bilateral uterine artery and endometrium blood flow, serum estradiol (E2) and progesterone (P), and pregnancy rate. The pregnancy rate will be evaluated during a 6-month follow-up after completion of the trial. All other outcomes will be evaluated before treatment, during the treatment of 1st, 2nd, and 3rd menstrual cycle, and 6 months after treatment. DISCUSSION: If the outcome confirms the effectiveness of electroacupuncture for thin endometrium in infertile women, this treatment will be proposed for application in clinical practice. TRIAL REGISTRATION: Chinese Clinical Trials Registry ChiCTR2000029983. Registered on 18 February 2020 SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-021-05029-7. BioMed Central 2021-01-21 /pmc/articles/PMC7818916/ /pubmed/33478562 http://dx.doi.org/10.1186/s13063-021-05029-7 Text en © The Author(s) 2021 Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Study Protocol
Li, Fangyuan
Lu, Hua
Wang, Xinxin
Zhang, Qi
Liu, Qianchen
Wang, Tong
Effectiveness of electroacupuncture for thin endometrium in infertile women: study protocol for a single-blind, randomized controlled trial
title Effectiveness of electroacupuncture for thin endometrium in infertile women: study protocol for a single-blind, randomized controlled trial
title_full Effectiveness of electroacupuncture for thin endometrium in infertile women: study protocol for a single-blind, randomized controlled trial
title_fullStr Effectiveness of electroacupuncture for thin endometrium in infertile women: study protocol for a single-blind, randomized controlled trial
title_full_unstemmed Effectiveness of electroacupuncture for thin endometrium in infertile women: study protocol for a single-blind, randomized controlled trial
title_short Effectiveness of electroacupuncture for thin endometrium in infertile women: study protocol for a single-blind, randomized controlled trial
title_sort effectiveness of electroacupuncture for thin endometrium in infertile women: study protocol for a single-blind, randomized controlled trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7818916/
https://www.ncbi.nlm.nih.gov/pubmed/33478562
http://dx.doi.org/10.1186/s13063-021-05029-7
work_keys_str_mv AT lifangyuan effectivenessofelectroacupunctureforthinendometriumininfertilewomenstudyprotocolforasingleblindrandomizedcontrolledtrial
AT luhua effectivenessofelectroacupunctureforthinendometriumininfertilewomenstudyprotocolforasingleblindrandomizedcontrolledtrial
AT wangxinxin effectivenessofelectroacupunctureforthinendometriumininfertilewomenstudyprotocolforasingleblindrandomizedcontrolledtrial
AT zhangqi effectivenessofelectroacupunctureforthinendometriumininfertilewomenstudyprotocolforasingleblindrandomizedcontrolledtrial
AT liuqianchen effectivenessofelectroacupunctureforthinendometriumininfertilewomenstudyprotocolforasingleblindrandomizedcontrolledtrial
AT wangtong effectivenessofelectroacupunctureforthinendometriumininfertilewomenstudyprotocolforasingleblindrandomizedcontrolledtrial