Letrozole Versus Chinese Herbal Medicine on Polycystic Ovary Syndrome (PCOS)
The Effects of Chinese Herbal Medicine and Letrozole on Live Birth in Infertile Women With Polycystic Ovary Syndrome:A Double-blind Randomized Controlled Trial
1 other identifier
interventional
420
1 country
18
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 site. Participants will be randomized into one of the two treatment arms: letrozole and CHMG or letrozole and CHMG placebo. CHMG or its placebo will be taken twice a day for up to six months. Letrozole (2.5 mg daily) was given on days 3-7 of the menstrual cycle after a spontaneous period or withdrawal bleeding, and the dose will be increased to 5.0 mg daily during the last three months for non-pregnant women in both groups.The aim of the present study is to determine the efficacy of combined treatment with letrozole and CHMG on improving live birth rates in infertile Chinese women with PCOS. Our hypothesis is that the combination of letrozole and CHMG is more likely to increase the ovulation rate and decrease the miscarriage rate and result in a higher live birth rate in PCOS women than letrozole alone.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2009
Longer than P75 for not_applicable
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 6, 2011
CompletedFirst Posted
Study publicly available on registry
September 9, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedNovember 5, 2013
November 1, 2013
4.9 years
September 6, 2011
November 4, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Live birth rate
Up to 2 years
Secondary Outcomes (9)
Ovulation rate
Up to 1 year
Miscarriage rate
Up to 1 year
Change in hormonal profile
Up to 1 year
Change in metabolic profile
Up to 1 year
Change in physical measurements
Up to 1 year
- +4 more secondary outcomes
Study Arms (2)
Letrozole+ Chinese herbal medicine granules
EXPERIMENTALLetrozole+ Chinese herbal medicine granules placebo
PLACEBO COMPARATORInterventions
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.
twice a day for 6 month
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
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, 150001, China
Dept Obs & Gyn, First Affiliated Hospital National Key Discipline and Trial Base Heilongjiang University of Chinese Medicine
Herbin, Heilongjiang, 150040, 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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor and Chairman Dept Obs & Gyn, First Affiliated Hospital
Study Record Dates
First Submitted
September 6, 2011
First Posted
September 9, 2011
Study Start
September 1, 2009
Primary Completion
August 1, 2014
Study Completion
August 1, 2014
Last Updated
November 5, 2013
Record last verified: 2013-11