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01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Trials 1/2016

Effectiveness of electroacupuncture for polycystic ovary syndrome: study protocol for a randomized controlled trial

Zeitschrift:
Trials > Ausgabe 1/2016
Autoren:
Jiao Chen, Shuwei Feng, Jiuzhi Zeng, Xi Wu, Mingxiao Yang, Hongzhi Tang, Huaying Fan, Jie Yang, Fanrong Liang
Wichtige Hinweise

Competing interests

The authors declare that they have no competing interests.

Authors’ contributions

JC and SWF contributed equally to the manuscript. JC conceived the study, participated in its design, and drafted the manuscript. SWF participated in the design and drafted the manuscript. JZZ, XW, MXY, HZT, and HYF participated in the design and helped to draft the manuscript. JY and FRL conceived the study, participated in its design, and helped to draft the manuscript. All authors read and approved the final manuscript.

Abstract

Background

Whether electroacupuncture is effective for patients with polycystic ovary syndrome is still inconclusive. Therefore, this study aims to evaluate the add-on effects of electroacupuncture to conventional drugs for the treatment of polycystic ovary syndrome.

Methods/design

This study is a two-center, open-labeled, randomized, controlled trial. A total of 116 eligible patients with polycystic ovary syndrome will be randomly allocated in a 1:1 ratio to the electroacupuncture plus clomiphene citrate group or to the clomiphene citrate group. Participants in the electroacupuncture plus clomiphene citrate group will receive electroacupuncture treatment in addition to clomiphene citrate capsules, whereas participants in the clomiphene citrate group will be prescribed clomiphene citrate capsules only. Electroacupuncture treatment will be performed from the fifth day of menstruation or withdrawal bleeding until the next menstruation, in three sessions per week for three menstrual cycles. The primary outcome is the ovulation rate. The secondary outcomes include the dominant follicle rate, mean number of dominant follicles, endometrial thickness, time point of ovulation, follicular size before ovulation, luteinizing hormone, estradiol level, and pregnancy rate. The measuring points for outcomes will be baseline and the completion of treatment. Any adverse events occurring during the trial process will be recorded. In addition, a quality-monitoring group independent from the research team will be set up to control the quality of the trial.

Discussion

The design and methodological rigor of this trial will allow for the collection of valuable data to evaluate the effectiveness of electroacupuncture for treating polycystic ovary syndrome. Therefore, this trial will contribute reliable evidence for use in clinical decision-making in acupuncture therapy of polycystic ovary syndrome as well as to future research in acupuncture for polycystic ovary syndrome.

Trial registration

Chinese Clinical Trial Registry, ChiCTR-IOR-15007358, registered on 26 October 2015
Literatur
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