Spots Global Cancer Trial Database for Acupuncture and Clomiphene Citrate on Live Birth in Anovulatory Women With Polycystic Ovary Syndrome
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Trial Identification
Brief Title: Acupuncture and Clomiphene Citrate on Live Birth in Anovulatory Women With Polycystic Ovary Syndrome
Official Title: Effect of Acupuncture and Clomiphene Citrate on Live Birth in Anovulatory Women With Polycystic Ovary Syndrome: A Randomized Controlled Trial (PCOSAct)
Study ID: NCT01573858
Study Description
Brief Summary: The objectives of the present trial are to test the following three hypotheses in anovulatory women with PCOS: 1. Acupuncture protocol 1 plus CC (Arm A) is more likely to result in live birth than acupuncture protocol 2 combined with CC (Arm B), 2. Acupuncture protocol 2 plus CC (Arm B) is more likely to result in live birth than acupuncture protocol 1 plus placebo (Arm C), 3. Acupuncture protocol 1 plus placebo (Arm C) is more likely to result in live birth than acupuncture protocol 2 plus placebo (Arm D).
Detailed Description: This is a multicenter, randomized, controlled, 2 by 2 factorial clinical trial for Chinese women with PCOS. Primary outcomes: - Live birth rate Secondary outcomes: * Ovulation rate * Ongoing pregnancy rate * Multiple pregnancy rate * Miscarriage rate * Hormonal profile * Metabolic profile * Side effect profile
Eligibility
Minimum Age: 20 Years
Eligible Ages: ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
First Affiliated Hospital，Anhui University of Chinese Medicine, Hefei, Anhui, China
First Affiliated Hospital，Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, China
Guangzhou Liwan Chinese Hospital, Guangzhou, Guangdong, China
Guangdong Chinese Hospital, Guangzhou, Guangdong, China
Daqing LongNa Hospital, Daqing, Heilongjiang, China
The Daqing Oilfield General Hospital, Daqing, Heilongjiang, China
Forth Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang, China
Second Affiliated Hospital，Heilongjiang University of Chinese Medicine, Harbin, Heilongjiang, China
First Affiliated Hospital，Heilongjiang University of Chinese Medicine, Harbin, Heilongjiang, China
Henan Chinese Medicine Hospital, Zhengzhou, Henan, China
Wuhan Tongji Hospital, Wuhan, Hubei, China
Hubei Chinese Medicine Hospital, Wuhan, Hubei, China
First Affiliated Hospital，Hunan University of Chinese Medicine, Changsha, Hunan, China
Maternal and Child Health Hospital of Huaian, Huaian, Jiangsu, China
Suzhou Chinese Medicine Hospital, Suzhou, Jiangsu, China
Maternal and Child Health Hospital of Xuzhou, Xuzhou, Jiangsu, China
Jiangxi University of Chinese Medicine Affiliated Hospital, Nanchang, Jiangxi, China
Dalian maternity hospital, Dalian, Liaoning, China
Liaoning University of Chinese Medicine Affiliated Hospital, Shenyang, Liaoning, China
Shanxi Chinese Medicine Hospital, Shangxi, Shanxi, China
First Affiliated Hospital，Tianjin University of Chinese Medicine, Tianjin, Tianjin, China
Tianjin Tanggu Maternity and Child Care Center, Tianjin, Tianjin, China
Integrated Chinese and Western Medicine Hospital of Zhejiang Province, Hangzhou, Zhejiang, China
Wenzhou Chinese Medicine Hospital, Wenzhou, Zhejiang, China
Hangzhou Chinese Medicine Hospital, Hangzhou, , China
Contact Details
Name: Xiaoke Wu, M.D., Ph.D.
Affiliation: First Affiliated Hospital of Heilongjiang Chinese Medicine University
Role: PRINCIPAL_INVESTIGATOR
Name: Lihui Hou, M.D.
Affiliation: First Affiliated Hospital of Heilongjiang Chinese Medicine University
Role: PRINCIPAL_INVESTIGATOR
Name: Richard Legro, MD
Affiliation: Steering Committee, Pennsylvania State University College of Medicine
Role: STUDY_CHAIR
Name: Heping Zhang, PHD
Affiliation: Data and Quality Control, Yale University
Role: STUDY_CHAIR
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