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Letrozole and Berberine in Infertile PCOS Patients


N/A
20 Years
40 Years
Open (Enrolling)
Female
Polycystic Ovary Syndrome

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Trial Information

Letrozole and Berberine in Infertile PCOS Patients


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Live-birth rate

Outcome Time Frame:

Up to 2 years

Safety Issue:

No

Principal Investigator

Lihui Hou, MD.

Investigator Role:

Study Chair

Investigator Affiliation:

The First Affliated Hospital,Heilongjiang University of Chinese Medicine .

Authority:

China: Ministry of Health

Study ID:

you070316

NCT ID:

NCT01116167

Start Date:

October 2009

Completion Date:

December 2013

Related Keywords:

  • Polycystic Ovary Syndrome
  • Polycystic Ovary Syndrome
  • Polycystic Ovary Syndrome

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