Letrozole Versus Chinese Herbal Medicine on Polycystic Ovary Syndrome (PCOS)
Status:
Unknown status
Trial end date:
2014-08-01
Target enrollment:
Participant gender:
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.