Letrozole Versus Chinese Herbal Medicine on Polycystic Ovary Syndrome (PCOS)
NCT ID: NCT01431352
Last Updated: 2013-11-05
Study Results
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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UNKNOWN
NA
420 participants
INTERVENTIONAL
2009-09-30
2014-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Letrozole+ Chinese herbal medicine granules
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.
Chinese herbal medicine granules or Chinese herbal medicine granules placebo
twice a day for 6 month
Letrozole+ Chinese herbal medicine granules placebo
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.
Interventions
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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.
Chinese herbal medicine granules or Chinese herbal medicine granules placebo
twice a day for 6 month
Eligibility Criteria
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Inclusion Criteria
2. History of at least one year of infertility.
3. Age between 20 and 40 years old.
4. 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.
5. Normal uterine cavity and at least one tube patent upon hysterosalpingography or HyCoSy.
Exclusion Criteria
2. History of other endocrine disorders.
3. Use of hormonal therapy, including metformin, in the past 3 months.
4. Previous sterilization procedures (vasectomy or tubal ligation) that have been reversed.
20 Years
40 Years
FEMALE
No
Sponsors
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Heilongjiang University of Chinese Medicine
OTHER
Responsible Party
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Xiaoke Wu
Professor and Chairman Dept Obs & Gyn, First Affiliated Hospital
Locations
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Affiliated Hospital of Anhui University of Chinese Medicine
Hefei, Anhui, China
Guangzhou Medical School First Affiliated Hospital
Guangzhou, Guangdong, China
Daqing Longnan hospital
Daqing, Heilongjiang, China
Daqing Oilfield General Hospital
Daqing, Heilongjiang, China
First Affliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Dept Obs & Gyn, First Affiliated Hospital National Key Discipline and Trial Base Heilongjiang University of Chinese Medicine
Herbin, Heilongjiang, China
Mudanjiang maternal and children hospital
Mudanjiang, Heilongjiang, China
2nd Affiliated Hospital of Henan University of Chinese Medicine
Zhengzhou, Henan, China
First Affiliated Hospital of Hunan University of Chinese
Changsha, Hunan, China
SuqianMaternal and Child Health Hospital
Suqian, Jiangsu, China
Maternal and Child Health Hospital of Xuzhou
Xuzhou, Jiangsu, China
First Hospital, Jiangxi college of Chinese Medicine
Nanchang, Jiangxi, China
Dalian Maternal and Child Health Hospital
Dalian, Liaoning, China
Shanxi Hospital of Chinese Medicine
Taiyuan, Shanxi, China
First Affiliated Hospital of Tianjin University of Chinese Medicine
Tianjin, Tianjin Municipality, China
Second Affiliated Hospital, Tianjin University of Chinese Medicine
Tianjin, Tianjin Municipality, China
Zhejiang province hospital of integrated traditional and western medicine
Hangzhou, Zhejiang, China
Second Affiliated Hospital of Heilongjiang University of Chinese Medicine
Harbin, , China
Countries
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Central Contacts
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Facility Contacts
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Muer An, MD
Role: primary
Lihui Hou, MD.
Role: primary
Xin Sun, MD
Role: primary
Other Identifiers
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Letrozole
Identifier Type: -
Identifier Source: org_study_id