NCT01431352

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 420 (estimated)
• Sponsor: Heilongjiang University of Chinese Medicine · Academic / Other
• Sex: Female
• Age: 20 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Polycystic Ovary Syndrome

Interventions

Type	Name	Description
DRUG	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.
DRUG	Chinese herbal medicine granules or Chinese herbal medicine granules placebo	twice a day for 6 month

Timeline

• Start date: 2009-09-01
• Primary completion: 2014-08-01
• Completion: 2014-08-01
• First posted: 2011-09-09
• Last updated: 2013-11-05

Locations

18 sites across 1 country: China