Table of Contents Author Guidelines Submit a Manuscript
Evidence-Based Complementary and Alternative Medicine
Volume 2013, Article ID 527303, 11 pages
http://dx.doi.org/10.1155/2013/527303
Research Article

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

1Department of Obstetrics and Gynecology, First Affiliated Hospital, Heilongjiang University of Chinese Medicine, Harbin 150040, China
2Chinese Clinical Registry, Chinese Cochrane Centre, Chinese Evidence-Based Medicine Centre, INCLEN CERTC, West China Hospital, Sichuan University, Chengdu 610041, China
3Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Bei San Huan Dong Lu 11, Chaoyang District, Beijing 100029, China
4Department of Obstetrics and Gynecology, The University of Hong Kong, Queen Mary Hospital, Hong Kong Special Administrative Region, China
5Institute of Neuroscience and Physiology, Department of Physiology, Sahlgrenska Academy, University of Gothenburg, 405 30 Gothenburg, Sweden
6Department of Obstetrics and Gynecology, Pennsylvania State University College of Medicine, Hershey, PA 17033, USA
7Department of Biostatistics, Yale University School of Public Health, New Haven, CT 06511, USA

Received 9 February 2013; Revised 29 May 2013; Accepted 1 July 2013

Academic Editor: Rosa Schnyer

Copyright © 2013 Hongying Kuang et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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.