• Yingying Deng, Jingshu Gao, Hongli Ma, Rong Wang, Xiuhua Chen, Hongxia Ma, Xiaofeng Xu, Juan Li, and Xiaoke Wu.
• the First Affiliated Hospital of Heilongjiang University of CM, Haerbin 150040, China.
• Zhongguo Zhen Jiu. 2017 May 12; 37 (5): 541-544.

AbstractThe design of research protocol and quality control are the key to ensure the quality of clinical trial. A randomized clinical trial regarding the effects of medication combined with acupuncture on live birth rate in polycystic ovary syndrome (PCOS), which was initially designed as a comparative effectiveness research, then added with an acupuncture control group and finally became a factorial analysis, is taken as an example to explain the protocol design and optimization process, demonstrating the high level of methodology design and international recognization. By a series of measurements, such as unified purchase of acupuncture equipment, multiple trainings and assessments for acupuncturists' knowledge and operation standardization, in-site supervision of local center experts, the standard operation of acupuncture could be ensured and the credibility and scientificity of research results could be improved.

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