Acupuncture and Clomiphene Citrate for Live Birth in Polycystic Ovary Syndrome: Study Design of a Randomized Controlled Trial

Abstract

Acupuncture is an alternative therapy to induce ovulation in women with polycystic ovary syndrome (PCOS), but there is no study reporting the live birth rate following ovulation induction by acupuncture or its potential as an adjuvant treatment to clomiphene citrate (CC). We assess the efficacy of acupuncture with or without CC in achieving live births among 1000 PCOS women in Mainland China. This paper reports the methodology of an ongoing multicenter randomized controlled trial. The randomization scheme is coordinated through the central mechanism and stratified by the participating sites. Participants will be randomized into one of the four treatment arms: (A) true acupuncture and CC, (B) control acupuncture and CC, (C) true acupuncture and placebo CC, and (D) control acupuncture and placebo CC. To ensure the quality and integrity of the trial we have developed a unique multinational team of investigators and Data and Safety Monitoring Board. Up to the end of April 2013, 326 subjects were recruited. In conclusion, the success of this trial will allow us to evaluate the additional benefit of acupuncture beyond the first line medicine for fertility treatment in PCOS women in an unbiased manner.

Effect of hyperinsulinaemia and insulin resistance on endocrine, metabolic and fertility outcomes in women with polycystic ovary syndrome undergoing ovulation induction

“…The protocol was approved by the local ethics committees at all sites, and all women signed a consent form before being enrolled in the trial. The study design, methods, and inclusion and exclusion criteria have been described in detail else where, and the main results were published in details in JAMA …”

Acupuncture for polycystic ovarian syndrome

“…[9] The results of this RCT will add more solid scientific evidence on the effectiveness and safety of acupuncture for patients with PCOS.…”

Effect of Acupuncture and Clomiphene in Chinese Women With Polycystic Ovary Syndrome

“…Details of the study design, rationale for the primary and secondary outcome measures, power analyses, and the statistical analysis plan have been previously published. 16 The full trial protocol is available in Supplement 1. The institutional review boards at the local sites approved the protocol, and all patients together with their partners provided written informed consent before joining the study.…”

“…Differences in the effects of clomiphene vs placebo ( 16.4%; 95% CI, 7.2% to 25.7%). The most common adverse events were gestational diabetes mellitus and preterm labor.…”