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Randomized Controlled Trial
. 2016 Oct 7;6(10):e010955.
doi: 10.1136/bmjopen-2015-010955.

Comparison of acupuncture pretreatment followed by letrozole versus letrozole alone on live birth in anovulatory infertile women with polycystic ovary syndrome: a study protocol for a randomised controlled trial

Juan Li  1 , Ernest Hung Yu Ng  2 , Elisabet Stener-Victorin  3 , Zhenxing Hu  4 , Wanting Wu  1 , Maohua Lai  1 , Taixiang Wu  5 , Hongxia Ma  1
Affiliations
Randomized Controlled Trial

Comparison of acupuncture pretreatment followed by letrozole versus letrozole alone on live birth in anovulatory infertile women with polycystic ovary syndrome: a study protocol for a randomised controlled trial

Juan Li et al. BMJ Open. .

Erratum in

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: NCT02491320.

Keywords: acupuncture pretreatment; letrozole; live birth rate; polycystic ovary syndrome.

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Conflict of interest statement

Conflicts of Interest: None declared.

Figures

Figure 1
Figure 1
The study flow chart Main Document. HOMA-IR, homeostatic model assessment of insulin resistance; PCOS, polycystic ovary syndrome.
See this image and copyright information in PMC

References

    1. Ghazeeri G, Kutteh WH, Bryer-Ash M et al. . Effect of rosiglitazone on spontaneous and clomiphene citrate-induced ovulation in women with polycystic ovary syndrome. Fertil Steril 2003;79:562–6. 10.1016/S0015-0282(02)04843-4 - DOI - PubMed
    1. Qiao J. [The diagnosis and treatment for amenorrhea in polycystic ovary syndrome]. Zhongguo Shi Yong Fu Ke Yu Chan Ke Za Zhi 2008;24:902–4.
    1. Katulski K, Czyzyk A, Podfigurna-Stopa A et al. . Pregnancy complications in polycystic ovary syndrome patients. Gynecol Endocrinol 2015;31:87–91. 10.3109/09513590.2014.974535 - DOI - PubMed
    1. Lin SQ, He FF, Chen ZJ et al. . [Clinical progress of gynecological endocrinology]. Edition 1. Beijing: Tsinghua Tongfang CD-ROM electronic publishing house 2013:106–9.
    1. Legro RS, Brzyski RG, Diamond MP et al. . Letrozole versus clomiphene for infertility in the polycystic ovary syndrome. N Engl J Med 2014;371:119–29. 10.1056/NEJMoa1313517 - DOI - PMC - PubMed

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