Clinical Trial

Letrozole Extended vs Traditional Therapy for Ovulation Induction in Women With PCOS (PROLEx-PCOS)

Study acronym: PROLEx-PCOS
Recruiting
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Record status
This record was last updated November 28, 2025 (before its estimated July 30, 2026 completion). Its status may not reflect the trial's current state.
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).
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-08-29.
Trial Details
NCT Number NCT07159880
Lead Sponsor GABRIEL MONTEIRO PINHEIRO
Conditions PCOS (Polycystic Ovary Syndrome), Infertility, Anovulation
Enrollment 20 participants
Start Date 2025-09-01
Primary Completion 2026-07-30 (estimated)
Study Completion 2026-07-30 (estimated)
Updated on ClinicalTrials.gov 2025-11-28