Polycystic Ovary Syndrome (PCOS): Effect Of Letrozole and Berberine

Not Applicable

• Conditions: Polycystic Ovary Syndrome
• Interventions: Drug: Letrozole -Berberine; Drug: Letrozole; Drug: Berberine

• Registration Number: NCT01116167
• Lead Sponsor: Heilongjiang University of Chinese Medicine

Brief Summary

Polycystic ovary syndrome (PCOS) is a heterogeneous disorder affecting almost4%-7% of the female population of reproductive age. Its heterogeneity is characterized by a wide spectrum of features, including ovulatory dysfunction and infertility, hyperandrogenism, hyperinsulinemia, insulin resistance (IR), and progression to type 2 diabetes.Since the Ming Dynasty in China,PCOS has been defined as "phlegm and wetness"infertility in traditional Chinese medicine ,namely "metabolic infertility".Chinese herbs have been used to treat PCOS for thousands of years with good effects.Berberine has also been used for diabetic patients in traditional Chinese medicine for hundreds of years. Recent studies have reported its effects on hyperglycemia and dyslipidemia.The purpose of this study is to determine whether Letrozole combined with berberine are effective in the treatment of infertile PCOS patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2010-04-27
• Study First Submitted QC: 2010-05-03
• Study First Posted: 2010-05-04
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-17
• Last Update Posted: 2013-05-20
• Primary Completion: 2013-12
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 660

Inclusion Criteria

• Chinese women

• Age between 20 and 40 years.

• Confirmed diagnosis of PCOS according to the Rotterdam 2003 criteria (2 out of 3):

  1. Oligo- or anovulation
  2. Clinical and/or biochemical signs of hyperandrogenism
  3. Polycystic ovaries and exclusion of other etiologies (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome)

• At least one patent tube and normal uterine cavity shown by hysterosalpingogram, HyCoSi or diagnostic laparoscopy within three years.

• Sperm concentration 20×106/mL and progressive motility (grades a and b) ≥50%.

Exclusion Criteria

• Use of hormonal drugs or other medications including Chinese herbal prescriptions in the past 3 months.
• Patients with known sever organ dysfunction or mental illness.
• Pregnancy, post-abortion or postpartum within the past 6 weeks.
• Breastfeeding within the last 6 months.
• Not willing to give written consent to the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Letrozole -Berberine	Letrozole -Berberine	-
Letrozole	Letrozole	-
Berberine	Berberine	-

Primary Outcome Measures

Name	Time	Method
Live-birth rate	Up to 2 years

Secondary Outcome Measures

Name	Time	Method
Ovulation rate	Up to 1 year
Other pregnancy complications such as early pregnancy loss, gestational diabetes mellitus, pregnancy-induced hypertension and birth of small-for-gestational-age (SGA) babies.	Up to 1 year
Multiple pregnancy rate	Up to 1 year.
Side effect.	Up to 1 year
Ongoing pregnancy rate at around gestation 8-10 weeks	Up to 1 year
Miscarriage rate: loss of an intrauterine pregnancy before 20 completed weeks of gestation	Up to 1 year
Infant outcome	Up to 1 year
Changes in metabolic profile: glucose and insulin concentrations, cholesterol, triglycerides, high density lipoprotein (HDL-C) and low density lipoprotein (LDL-C)	Up to 1 year
Changes in hormonal profile: Follicle-stimulating hormone (FSH), Luteinizing hormone (LH), total testosterone (T), Sex hormone-binding globulin (SHBG) and Dehydroepiandrosterone sulfate (DHEAS)	Up to 1 year

Trial Locations

Locations (18)

Shanxi Hospital of Chinese Medicine; 🇨🇳 Taiyuan, Shanxi, China

SuqianMaternal and Child Health Hospital; 🇨🇳 Suqian, Jiangsu, China

Mudanjiang maternal and children hospital; 🇨🇳 Mudanjiang, Heilongjiang, China

Affiliated Hospital of Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China

Obstetrics and Gynecology,Heilongjiang University of Chinese Medicine; 🇨🇳 Harbin, Heilongjiang, China

First Affliated Hospital of Harbin Medical University; 🇨🇳 Harbin, Heilongjiang, China

2nd Affiliated Hospital of Henan University of Chinese Medicine; 🇨🇳 Zhengzhou, Henan, China

First Hospital, Jiangxi college of Chinese Medicine; 🇨🇳 Nanchang, Jiangxi, China

Dalian Maternal and Child Health Hospital; 🇨🇳 Dalian, Liaoning, China

First Affiliated Hospital of Tianjin University of Chinese Medicine; 🇨🇳 Tianjin, Tianjin, China

Zhejiang province hospital of integrated traditional and western medicine; 🇨🇳 Hangzhou, Zhejiang, China

Second Affiliated Hospital, Tianjin University of Chinese Medicine; 🇨🇳 Tianjin, Tianjin, China

Second Affiliated Hospital of Heilongjiang University of Chinese Medicine; 🇨🇳 Harbin, China

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 LongNa Hospital; 🇨🇳 Daqing, Heilongjiang, China

First Affiliated Hospital of Hunan University of Chinese; 🇨🇳 Changsha, Hunan, China