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

Study Overview
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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 wetnessinfertility 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.

Official Title
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Letrozole and Berberine in Infertile PCOS Patients

Conditions
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Polycystic Ovary Syndrome

Intervention / Treatment
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* Drug: Letrozole -Berberine
* Drug: Letrozole
* Drug: Berberine


Participation Criteria
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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): Oligo- or anovulation Clinical and/or biochemical signs of hyperandrogenism 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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Letrozole -Berberine<br> | Drug: Letrozole -Berberine<br>* 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.<br>|
| Active Comparator: Letrozole<br> | Drug: Letrozole<br>* 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<br>|
| Active Comparator: Berberine<br> | Drug: Berberine<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Live-birth rate |  | Up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ovulation rate |  | Up to 1 year | 
| Ongoing pregnancy rate at around gestation 8-10 weeks |  | Up to 1 year | 
| Multiple pregnancy rate |  | Up to 1 year. | 
| Miscarriage rate: loss of an intrauterine pregnancy before 20 completed weeks of gestation |  | 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 | 
| 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 | 
| Side effect. |  | Up to 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Polycystic Ovary Syndrome