Symptoms and General Pathology

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Neoplasms

Gland and Hormone Related Diseases

Syndrome

Infertility

Polycystic Ovary Syndrome

Anovulation

Genital Diseases

Urogenital Diseases

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

Endocrine System Diseases

Anticoagulants

All Drugs and Chemicals

Reproductive Control Agents

Other Dietary Supplements

Citric Acid

Sodium Citrate

Clomiphene

Enclomiphene

Zuclomiphene

Citrate

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 1

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.

Acupuncture treatment 2

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 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

Xiaoke Wu, M.D., Ph.D.

Lihui Hou, M.D.

Richard Legro, MD

Heping Zhang, PHD

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).

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

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

Effect of Acupuncture and Clomiphene Citrate on Live Birth in Anovulatory Women With Polycystic Ovary Syndrome: A Randomized Controlled Trial (PCOSAct)

loss of an intrauterine pregnancy before 20 completed weeks of gestation.

Hormonal profile include: Testosterone(T), Sex hormone-binding globulin (SHBG), Follicle stimulating hormone (FSH),Luteinizing hormone(LH),and Dehydroepiandrosterone sulfate (DHEAS).

Metabolic profile includes: Serum glucose concentration, Insulin concentration, cholesterol, Triglycerides (TG), High density lipoprotein cholesterol (HDL-C) and Low density lipoprotein cholesterol (LDL-C)

Side effects of CC include hot flashes, mood changes, bloating, formation of ovarian cysts, and pain, extremely rare are pituitary apoplexy and deep venous thrombosis. The major side effects of acupuncture are local skin irritation, discomfort, and vasovagal reactions during the procedure. All above mentioned side effects will be recorded weekly.

Yale University

Penn State University

Göteborg University

The University of Hong Kong

Beijing University of Chinese Medicine

Sichuan University

Second Affiliated Hospital of Heilongjiang University of Chinese Medicine

Harbin Medical University

Daqing Oil Field Hospital

Daqing Longnan Hospital

Liaoning University of Traditional Chinese Medicine

The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

Tianjin Tanggu Maternity and Child Care Center

Wenzhou Chinese Medicine Hospital

Jiangsu Province Hospital of Traditional Chinese Medicine

Hangzhou Chinese Medicine Hospital

Shanxi Chinese Medicine Hospital

Henan Chinese Medicine Hospital

Maternal and Child Health Hospital of Xuzhou

Huaian Maternal and Child Health Care Hospital

The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine

Suzhou Chinese Medicine Hospital

Wuhan TongJi Hospital

Hubei Chinese Medicine Hospital

Jiangxi University of Chinese Medicine Affiliated Hospital

The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine

The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Acupuncture and Clomiphene Citrate on Live Birth in Anovulatory Women With Polycystic Ovary Syndrome	NCT01573858	Pregnancy Polycystic Ovar... Infertility	Acupuncture tre... Acupuncture tre... CC CC placebo	20 Years - 40 Years	Heilongjiang University of Chinese Medicine
Acupuncture and Clomiphene Citrate on Live Birth in Anovulatory Women With Polycystic Ovary Syndrome	NCT01573858	Pregnancy Polycystic Ovar... Infertility	Acupuncture tre... Acupuncture tre... CC CC placebo	20 Years - 40 Years	Heilongjiang University of Chinese Medicine

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