1,000
Participants
Start Date
July 6, 2012
Primary Completion Date
November 8, 2014
Study Completion Date
October 7, 2015
Acupuncture treatment 1
Two sets of acupuncture points will be alternated every second treatment. The first set consists of CV3, CV 6, and ST 29 bilaterally,SP 6 and SP 9 bilaterally. Needles will also be placed in LI bilaterally and GV 20. CV 3, CV 6, ST 29, SP 6, and SP 9 will be connected to and electrical stimulator and stimulated with low-frequency EA of 2Hz, 0.3 ms.
Acupuncture treatment 2
Needles will be inserted to a depth of \<5 mm, one in each shoulder and on in each upper arm at non-acupuncture points. Electrodes will be attached to the needles and the stimulator will be turned on at an intensity of zero (no active current) in order to mimic EA in the acupuncture treatment 1. No manual stimulation of the needles will be performed.
CC
CC 50 mg every day for 5 days (day 3-7 of cycle), for a total of 4 cycles. Non-response will be defined after 4 weeks of CC placebo administration with 3 consecutive weekly negative P4 and hCG levels. Then during the fifth week a higher dose consisting of one more tablet per day (up to 3 tablets per day at third or fourth cycles, if they remain non-responders) will be given 5 days.
CC placebo
CC placebo 50 mg every day for 5 days (day 3-7 of cycle), for a total of 4 cycles. Non-response will be defined after 4 weeks of CC Placebo administration with 3 consecutive weekly negative P4 and hCG levels. Then during the fifth week a higher dose consisting of one more tablet per day (up to 3 tablets per day at third or fourth cycles, if they remain non-responders) will be given 5 days.
Liaoning University of Chinese Medicine Affiliated Hospital, Shenyang
Dalian maternity hospital, Dalian
Forth Affiliated Hospital of Harbin Medical University, Harbin
Second Affiliated Hospital,Heilongjiang University of Chinese Medicine, Harbin
First Affiliated Hospital,Heilongjiang University of Chinese Medicine, Harbin
Daqing LongNa Hospital, Daqing
The Daqing Oilfield General Hospital, Daqing
Suzhou Chinese Medicine Hospital, Suzhou
Maternal and Child Health Hospital of Xuzhou, Xuzhou
Maternal and Child Health Hospital of Huaian, Huaian
First Affiliated Hospital,Anhui University of Chinese Medicine, Hefei
First Affiliated Hospital,Tianjin University of Chinese Medicine, Tianjin
Tianjin Tanggu Maternity and Child Care Center, Tianjin
Integrated Chinese and Western Medicine Hospital of Zhejiang Province, Hangzhou
Hangzhou Chinese Medicine Hospital, Hangzhou
Wenzhou Chinese Medicine Hospital, Wenzhou
Jiangxi University of Chinese Medicine Affiliated Hospital, Nanchang
First Affiliated Hospital,Hunan University of Chinese Medicine, Changsha
Wuhan Tongji Hospital, Wuhan
Hubei Chinese Medicine Hospital, Wuhan
Henan Chinese Medicine Hospital, Zhengzhou
First Affiliated Hospital,Guangzhou University of Chinese Medicine, Guangzhou
Guangzhou Liwan Chinese Hospital, Guangzhou
Guangdong Chinese Hospital, Guangzhou
Shanxi Chinese Medicine Hospital, Shangxi
Yale University
OTHER
Penn State University
OTHER
Göteborg University
OTHER
The University of Hong Kong
OTHER
Beijing University of Chinese Medicine
OTHER
Sichuan University
OTHER
Second Affiliated Hospital of Heilongjiang University of Chinese Medicine
OTHER
Harbin Medical University
OTHER
Daqing Oil Field Hospital
OTHER
Daqing Longnan Hospital
UNKNOWN
Liaoning University of Traditional Chinese Medicine
OTHER
The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
OTHER
Tianjin Tanggu Maternity and Child Care Center
UNKNOWN
Wenzhou Chinese Medicine Hospital
UNKNOWN
Jiangsu Province Hospital of Traditional Chinese Medicine
OTHER
Hangzhou Chinese Medicine Hospital
UNKNOWN
Shanxi Chinese Medicine Hospital
UNKNOWN
Henan Chinese Medicine Hospital
UNKNOWN
Maternal and Child Health Hospital of Xuzhou
UNKNOWN
Huaian Maternal and Child Health Care Hospital
OTHER
The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
OTHER
Suzhou Chinese Medicine Hospital
UNKNOWN
Wuhan TongJi Hospital
OTHER
Hubei Chinese Medicine Hospital
UNKNOWN
Jiangxi University of Chinese Medicine Affiliated Hospital
UNKNOWN
The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
OTHER
The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
OTHER
Guangdong Provincial People's Hospital
OTHER
Guangzhou Liwan Chinese Hospital
UNKNOWN
Dalian maternity hospital
UNKNOWN
Heilongjiang University of Chinese Medicine
OTHER