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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

660 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2013-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Polycystic Ovary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Letrozole -Berberine

Group Type EXPERIMENTAL

Letrozole -Berberine

Intervention Type DRUG

Letrozole

2.5 mg letrozole daily from day 5 of the menses for 5 days for month 1 to 3, 5.0 mg letrozole daily from day 5 of the menses for 5 days for month 4 to 6.

Berberine

1.5g daily for 6 month.

Letrozole

Group Type ACTIVE_COMPARATOR

Letrozole

Intervention Type DRUG

Letrozole

2.5 mg letrozole daily from day 5 of the menses for 5 days for month 1 to 3, 5.0 mg letrozole daily from day 5 of the menses for 5 days for month 4 to 6.

Berberine Placebo

5 tablet tds for 6 months

Berberine

Group Type ACTIVE_COMPARATOR

Berberine

Intervention Type DRUG

Berberine

1.5g daily for 6 month.

Letrozole placebo

1 tablet daily from day 5 of the menses for 5 days for month 1 to 3, 2 tablets daily from day 5 of the menses for 5 days for month 4 to 6.

Interventions

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Letrozole -Berberine

Letrozole

2.5 mg letrozole daily from day 5 of the menses for 5 days for month 1 to 3, 5.0 mg letrozole daily from day 5 of the menses for 5 days for month 4 to 6.

Berberine

1.5g daily for 6 month.

Intervention Type DRUG

Letrozole

Letrozole

2.5 mg letrozole daily from day 5 of the menses for 5 days for month 1 to 3, 5.0 mg letrozole daily from day 5 of the menses for 5 days for month 4 to 6.

Berberine Placebo

5 tablet tds for 6 months

Intervention Type DRUG

Berberine

Berberine

1.5g daily for 6 month.

Letrozole placebo

1 tablet daily from day 5 of the menses for 5 days for month 1 to 3, 2 tablets daily from day 5 of the menses for 5 days for month 4 to 6.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Xiaoke Wu

Professor and Department Chairman of Obstetrics and Gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lihui Hou, MD.

Role: STUDY_CHAIR

The First Affliated Hospital,Heilongjiang University of Chinese Medicine .

Xiaoke Wu, MD.PhD.

Role: STUDY_CHAIR

The First Affliated Hospital,Heilongjiang University of Chinese Medicine

Locations

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