Acupuncture and Clomiphene Citrate on Live Birth in Anovulatory Women With Polycystic Ovary Syndrome

NACompletedINTERVENTIONAL
Enrollment

1,000

Participants

Timeline

Start Date

July 6, 2012

Primary Completion Date

November 8, 2014

Study Completion Date

October 7, 2015

Conditions
PregnancyPolycystic Ovary SyndromeInfertility
Interventions
OTHER

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.

OTHER

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.

OTHER

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.

OTHER

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.

Trial Locations (25)

110000

Liaoning University of Chinese Medicine Affiliated Hospital, Shenyang

116000

Dalian maternity hospital, Dalian

150001

Forth Affiliated Hospital of Harbin Medical University, Harbin

Second Affiliated Hospital,Heilongjiang University of Chinese Medicine, Harbin

150040

First Affiliated Hospital,Heilongjiang University of Chinese Medicine, Harbin

163000

Daqing LongNa Hospital, Daqing

The Daqing Oilfield General Hospital, Daqing

215003

Suzhou Chinese Medicine Hospital, Suzhou

221000

Maternal and Child Health Hospital of Xuzhou, Xuzhou

223002

Maternal and Child Health Hospital of Huaian, Huaian

230031

First Affiliated Hospital,Anhui University of Chinese Medicine, Hefei

300193

First Affiliated Hospital,Tianjin University of Chinese Medicine, Tianjin

300451

Tianjin Tanggu Maternity and Child Care Center, Tianjin

310000

Integrated Chinese and Western Medicine Hospital of Zhejiang Province, Hangzhou

Hangzhou Chinese Medicine Hospital, Hangzhou

325000

Wenzhou Chinese Medicine Hospital, Wenzhou

330000

Jiangxi University of Chinese Medicine Affiliated Hospital, Nanchang

410007

First Affiliated Hospital,Hunan University of Chinese Medicine, Changsha

430000

Wuhan Tongji Hospital, Wuhan

430060

Hubei Chinese Medicine Hospital, Wuhan

450002

Henan Chinese Medicine Hospital, Zhengzhou

510000

First Affiliated Hospital,Guangzhou University of Chinese Medicine, Guangzhou

Guangzhou Liwan Chinese Hospital, Guangzhou

510120

Guangdong Chinese Hospital, Guangzhou

030012

Shanxi Chinese Medicine Hospital, Shangxi

All Listed Sponsors
collaborator

Yale University

OTHER

collaborator

Penn State University

OTHER

collaborator

Göteborg University

OTHER

collaborator

The University of Hong Kong

OTHER

collaborator

Beijing University of Chinese Medicine

OTHER

collaborator

Sichuan University

OTHER

collaborator

Second Affiliated Hospital of Heilongjiang University of Chinese Medicine

OTHER

collaborator

Harbin Medical University

OTHER

collaborator

Daqing Oil Field Hospital

OTHER

collaborator

Daqing Longnan Hospital

UNKNOWN

collaborator

Liaoning University of Traditional Chinese Medicine

OTHER

collaborator

The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

OTHER

collaborator

Tianjin Tanggu Maternity and Child Care Center

UNKNOWN

collaborator

Wenzhou Chinese Medicine Hospital

UNKNOWN

collaborator

Jiangsu Province Hospital of Traditional Chinese Medicine

OTHER

collaborator

Hangzhou Chinese Medicine Hospital

UNKNOWN

collaborator

Shanxi Chinese Medicine Hospital

UNKNOWN

collaborator

Henan Chinese Medicine Hospital

UNKNOWN

collaborator

Maternal and Child Health Hospital of Xuzhou

UNKNOWN

collaborator

Huaian Maternal and Child Health Care Hospital

OTHER

collaborator

The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine

OTHER

collaborator

Suzhou Chinese Medicine Hospital

UNKNOWN

collaborator

Wuhan TongJi Hospital

OTHER

collaborator

Hubei Chinese Medicine Hospital

UNKNOWN

collaborator

Jiangxi University of Chinese Medicine Affiliated Hospital

UNKNOWN

collaborator

The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine

OTHER

collaborator

The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine

OTHER

collaborator

Guangdong Provincial People's Hospital

OTHER

collaborator

Guangzhou Liwan Chinese Hospital

UNKNOWN

collaborator

Dalian maternity hospital

UNKNOWN

lead

Heilongjiang University of Chinese Medicine

OTHER

NCT01573858 - Acupuncture and Clomiphene Citrate on Live Birth in Anovulatory Women With Polycystic Ovary Syndrome | Biotech Hunter | Biotech Hunter