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Abstract
Introduction The high prevalence of insulin resistance in women with polycystic ovary syndrome (PCOS) is considered to be one of the major pathophysiological changes in PCOS that leads to anovulatory infertility. We hypothesise that electroacupuncture pretreatment improves insulin sensitivity and leads to a higher ovulation rate and greater chances of live birth after the induction of ovulation. The effect of electroacupuncture pretreatment followed by ovulation induction in women with anovulatory PCOS has not been investigated before, and we present here a randomised controlled trial to test this hypothesis by comparing electroacupuncture pretreatment followed by letrozole versus letrozole alone in anovulatory women with PCOS.
Methods/analysis This is a multicentre, randomised,and controlled trial. A total of 384 patients will be enrolled in this study and will be randomly allocated by a central randomisation system to the treatment group or the control group in a 1:1 ratio. The treatment group will undergo 16 weeks of electroacupuncture pretreatment followed by 4 cycles of letrozole, and the control group will only undergo 4 cycles of letrozole. The primary outcome will be the live birth rate. All statistical analyses will be performed using the SPSS program V.21.0 (SPSS, Chicago, Illinois, USA), and a p value <0.05 will be considered statistically significant.
Ethics/dissemination This study has been approved by the ethics committees of each participating centre. Written consent will be obtained from each patient and her husband before any study procedure is performed. Adverse events will be categorised, and the percentage of patients experiencing adverse events or serious adverse events during the treatment period will be documented. The results of this trial will be disseminated in peer-reviewed journals and presented at international meetings.
Trial registration number NCT02491333.
- acupuncture pretreatment
- live birth rate
- letrozole
- polycystic ovary syndrome
This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
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Footnotes
Contributors JL and EHYN contributed equally to this work. EHYN and HM conceived and designed the study. JL, EHYN and ES-V drafted and critically revised the manuscript for important intellectual content. HM and JL sought funding and ethical approval. TW was responsible for randomisation and data management. All authors contributed to the further writing of the manuscript and approved the final manuscript.
Funding This work was supported in part by the Natural Science Foundation of Guangdong Province, China (grant number 2015A030310508) and funded by the Science and Technology Planning Project of Guangdong Province, China (grant number 2014A020221060).
Disclaimer The funding sources had no role in the design of this study and will not have any role during its execution, analysis, data interpretation or decision to submit the results.
Competing interests None declared.
Patient consent Obtained.
Ethics approval This study has been approved by the Ethics Committee of the First Affiliated Hospital of Guangzhou Medical University, Xuzhou Maternity and Child Health Hospital, and Hexian Memorial Affiliated Hospital of Southern Medical University.
Provenance and peer review Not commissioned; externally peer reviewed.