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

Study acronym: PROLEx-PCOS
StatusRecruiting
PhaseNot applicable
Started
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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.

Record History

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  1. Start date changed from estimate of Aug 26, 2025 to Sep 1, 2025v2 Show 4 more changesShow less
    • Interventions: Letrozole (aromatase inhibitor) (Drug) to Extended Letrozole Therapy (Drug), Traditional Letrozole Therapy (Drug)
    • Study description shortened, about 172 words
    • Eligibility criteria expanded, about 1 word
    • Study title shortened, about 3 words
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT07159880
Lead Sponsor GABRIEL MONTEIRO PINHEIRO
Conditions
(from sponsor)		 PCOS (Polycystic Ovary Syndrome), Infertility, Anovulation
Related terms Anovulation, Infertility, Polycystic Ovary Syndrome
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov