Status:
UNKNOWN
Letrozole Versus Chinese Herbal Medicine on Polycystic Ovary Syndrome (PCOS)
Lead Sponsor:
Heilongjiang University of Chinese Medicine
Conditions:
Polycystic Ovary Syndrome
Eligibility:
FEMALE
20-40 years
Phase:
NA
Brief Summary
This is a multicenter double-blind randomized controlled trial. A total of 420 anovulatory Chinese women with PCOS will be recruited, and the randomization will be stratified by each participating sit...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Chinese women with PCOS. PCOS must have been diagnosed based on the presence of two of the following three Rotterdam criteria : (1) oligomenorrhea, anovulation; (2) hyperandrogenism; and (3) the observation of polycystic ovaries by sonography. Oligomenorrhea is defined as an intermenstrual interval \>35 days or \<8 menstrual bleedings in the past year. Amenorrhea is defined as an intermenstrual interval \>90 days.
- History of at least one year of infertility.
- Age between 20 and 40 years old.
- Normal semen analysis based on World Health Organization criteria (2010). The husband did not need to sign the consent form because semen analysis is part of the clinical assessment at the sites. A sperm concentration ≥15 × 106/mL and total motility ≥40% in the semen analysis of the husband was required for the woman to be included.
- Normal uterine cavity and at least one tube patent upon hysterosalpingography or HyCoSy.
- Exclusion criteria
- History of significant system diseases such as heart, lung, or kidney diseases.
- History of other endocrine disorders.
- Use of hormonal therapy, including metformin, in the past 3 months.
- Previous sterilization procedures (vasectomy or tubal ligation) that have been reversed.
Exclusion
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2014
Estimated Enrollment :
420 Patients enrolled
Trial Details
Trial ID
NCT01431352
Start Date
September 1 2009
End Date
August 1 2014
Last Update
November 5 2013
Active Locations (18)
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1
Affiliated Hospital of Anhui University of Chinese Medicine
Hefei, Anhui, China
2
Guangzhou Medical School First Affiliated Hospital
Guangzhou, Guangdong, China
3
Daqing Longnan hospital
Daqing, Heilongjiang, China
4
Daqing Oilfield General Hospital
Daqing, Heilongjiang, China