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

Heilongjiang University of Chinese Medicine

Status: Unknown

Conditions: Polycystic Ovary Syndrome

Treatments: Drug: Berberine; Drug: Letrozole; Drug: Letrozole -Berberine

Study type: Interventional

Funder types: Other

Identifiers

NCT01116167

you070316

Details and patient eligibility

About

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.

Enrollment: 660 estimated patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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660 participants in 3 patient groups

Letrozole -Berberine

Experimental group

Treatment:

Drug: Letrozole -Berberine

Letrozole

Active Comparator group

Treatment:

Drug: Letrozole

Berberine

Active Comparator group

Treatment:

Drug: Berberine