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Brief Title: Letrozole Versus Chinese Herbal Medicine on Polycystic Ovary Syndrome (PCOS)
Official Title: The Effects of Chinese Herbal Medicine and Letrozole on Live Birth in Infertile Women With Polycystic Ovary Syndrome:A Double-blind Randomized Controlled Trial
Study ID: NCT01431352
Brief Summary: This is a multicenter double-blind randomized controlled trial. A total of 420 anovulatory Chinese women with PCOS will be recruited, and the randomization will be stratified by each participating site. Participants will be randomized into one of the two treatment arms: letrozole and CHMG or letrozole and CHMG placebo. CHMG or its placebo will be taken twice a day for up to six months. Letrozole (2.5 mg daily) was given on days 3-7 of the menstrual cycle after a spontaneous period or withdrawal bleeding, and the dose will be increased to 5.0 mg daily during the last three months for non-pregnant women in both groups.The aim of the present study is to determine the efficacy of combined treatment with letrozole and CHMG on improving live birth rates in infertile Chinese women with PCOS. Our hypothesis is that the combination of letrozole and CHMG is more likely to increase the ovulation rate and decrease the miscarriage rate and result in a higher live birth rate in PCOS women than letrozole alone.
Detailed Description:
Minimum Age: 20 Years
Eligible Ages: ADULT
Sex: FEMALE
Healthy Volunteers: No
Affiliated Hospital of Anhui University of Chinese Medicine, Hefei, Anhui, China
Guangzhou Medical School First Affiliated Hospital, Guangzhou, Guangdong, China
Daqing Longnan hospital, Daqing, Heilongjiang, China
Daqing Oilfield General Hospital, Daqing, Heilongjiang, China
First Affliated Hospital of Harbin Medical University, Harbin, Heilongjiang, China
Dept Obs & Gyn, First Affiliated Hospital National Key Discipline and Trial Base Heilongjiang University of Chinese Medicine, Herbin, Heilongjiang, China
Mudanjiang maternal and children hospital, Mudanjiang, Heilongjiang, China
2nd Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou, Henan, China
First Affiliated Hospital of Hunan University of Chinese, Changsha, Hunan, China
SuqianMaternal and Child Health Hospital, Suqian, Jiangsu, China
Maternal and Child Health Hospital of Xuzhou, Xuzhou, Jiangsu, China
First Hospital, Jiangxi college of Chinese Medicine, Nanchang, Jiangxi, China
Dalian Maternal and Child Health Hospital, Dalian, Liaoning, China
Shanxi Hospital of Chinese Medicine, Taiyuan, Shanxi, China
First Affiliated Hospital of Tianjin University of Chinese Medicine, Tianjin, Tianjin, China
Second Affiliated Hospital, Tianjin University of Chinese Medicine, Tianjin, Tianjin, China
Zhejiang province hospital of integrated traditional and western medicine, Hangzhou, Zhejiang, China
Second Affiliated Hospital of Heilongjiang University of Chinese Medicine, Harbin, , China