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

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).

Conditions

• Pregnancy
• Polycystic Ovary Syndrome
• Infertility

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.

Sponsors & Collaborators

• Yale University

  collaborator OTHER

• Penn State University

  collaborator OTHER

• Göteborg University

  collaborator OTHER

• The University of Hong Kong

  collaborator OTHER

• Beijing University of Chinese Medicine

  collaborator OTHER

• Sichuan University

  collaborator OTHER

• Second Affiliated Hospital of Heilongjiang University of Chinese Medicine

  collaborator OTHER

• Harbin Medical University

  collaborator OTHER

• Daqing Oil Field Hospital

  collaborator OTHER

• Daqing Longnan Hospital

  collaborator UNKNOWN

• Liaoning University of Traditional Chinese Medicine

  collaborator OTHER

• The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

  collaborator OTHER

• Tianjin Tanggu Maternity and Child Care Center

  collaborator UNKNOWN

• Wenzhou Chinese Medicine Hospital

  collaborator UNKNOWN

• Jiangsu Province Hospital of Traditional Chinese Medicine

  collaborator OTHER

• Hangzhou Chinese Medicine Hospital

  collaborator UNKNOWN

• Shanxi Chinese Medicine Hospital

  collaborator UNKNOWN

• Henan Chinese Medicine Hospital

  collaborator UNKNOWN

• Maternal and Child Health Hospital of Xuzhou

  collaborator UNKNOWN

• Huaian Maternal and Child Health Care Hospital

  collaborator OTHER

• The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine

  collaborator OTHER

• Suzhou Chinese Medicine Hospital

  collaborator UNKNOWN

• Wuhan TongJi Hospital

  collaborator OTHER

• Hubei Chinese Medicine Hospital

  collaborator UNKNOWN

• Jiangxi University of Chinese Medicine Affiliated Hospital

  collaborator UNKNOWN

• The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine

  collaborator OTHER

• The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine

  collaborator OTHER

• Guangdong Provincial People's Hospital

  collaborator OTHER

• Guangzhou Liwan Chinese Hospital

  collaborator UNKNOWN

• Dalian maternity hospital

  collaborator UNKNOWN

• Heilongjiang University of Chinese Medicine

  lead OTHER

Principal Investigators

• Xiaoke Wu, M.D., Ph.D. · First Affiliated Hospital of Heilongjiang Chinese Medicine University

• Lihui Hou, M.D. · First Affiliated Hospital of Heilongjiang Chinese Medicine University

• Richard Legro, MD · Steering Committee, Pennsylvania State University College of Medicine

• Heping Zhang, PHD · Data and Quality Control, Yale University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

40 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-07-06

Primary Completion

2014-11-08

Completion

2015-10-07

Countries

• China

Study Locations