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Letrozole Extended vs Traditional Therapy for Ovulation Induction in Women With PCOS (PROLEx-PCOS)
Sponsor: GABRIEL MONTEIRO PINHEIRO
Summary
This randomized clinical trial aims to compare the efficacy and safety of extended letrozole therapy (5 mg/day for 10 days) versus standard letrozole therapy (5 mg/day for 5 days) for ovulation induction in women with polycystic ovary syndrome (PCOS). A total of 84 women aged 18-40 years will be randomized into two groups. Ovulation will be monitored by transvaginal ultrasound and confirmed with urinary LH testing and/or corpus luteum presence. The primary outcome is ovulation rate, while secondary outcomes include number and size of mature follicles, clinical pregnancy rate, multiple pregnancy rate, miscarriage rate, number of cycles until pregnancy, and incidence of ovarian hyperstimulation syndrome (OHSS).
Official title: Extended Therapy Versus Traditional Therapy With Letrozole for Ovulation Induction in Women With Polycystic Ovary Syndrome: A Randomized Controlled Trial
Key Details
Gender
FEMALE
Age Range
18 Years - 40 Years
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2025-09-01
Completion Date
2026-07-30
Last Updated
2025-11-28
Healthy Volunteers
Yes
Interventions
Traditional Letrozole Therapy
Traditional therapy group: 5 mg/day of letrozole for 5 days (cycle days 2-6).
Extended Letrozole Therapy
Extended therapy group: 5 mg/day of letrozole for 10 days (cycle days 2-12)
Locations (1)
Health Complex Dr Wladimir Arruda
São Paulo, São Paulo, Brazil