The Effects of Chinese Herbal Medicine and Letrozole on Live Birth in Infertile Women With Polycystic Ovary Syndrome:A Double-blind Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 420
- Locations
- 18
- Primary Endpoint
- Live birth rate
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Letrozole+ Chinese herbal medicine granules placebo
Intervention: Letrozole (Drug)
Letrozole+ Chinese herbal medicine granules
Intervention: Letrozole (Drug)
Letrozole+ Chinese herbal medicine granules
Intervention: Chinese herbal medicine granules or Chinese herbal medicine granules placebo (Drug)
Outcomes
Primary Outcomes
Live birth rate
Time Frame: Up to 2 years
Secondary Outcomes
- 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)
- Birth defects(Up to 1 year)
- Pregnancy complications(Up to 1 year)
- Safety parameters(Up to 1 year)
- Side effect profile(Up to 1 year)
Investigators
Xiaoke Wu
Professor and Chairman Dept Obs & Gyn, First Affiliated Hospital
Heilongjiang University of Chinese Medicine