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- Title
Acupuncture and Clomiphene Citrate for Live Birth in Polycystic Ovary Syndrome: Study Design of a Randomized Controlled Trial.
- Authors
Hongying Kuang; Yan Li; Xiaoke Wu; Lihui Hou; Taixiang Wu; Jianping Liu; Ernest Hung Yu Ng; Elisabet Stener-Victorin; Legro, Richard S.; Heping Zhang
- 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.
- Subjects
POLYCYSTIC ovary syndrome treatment; CLOMIPHENE; ACUPUNCTURE; EXPERIMENTAL design; INDUCED ovulation; RESEARCH funding; RANDOMIZED controlled trials; PATIENT selection; THERAPEUTICS
- Publication
Evidence-based Complementary & Alternative Medicine (eCAM), 2013, Vol 2013, p1
- ISSN
1741-427X
- Publication type
Article
- DOI
10.1155/2013/527303