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

Sponsor
GABRIEL MONTEIRO PINHEIRO
Study ID
NCT07159880
Status
Recruiting
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Conditions

  • Anovulation
  • Infertility
  • PCOS (Polycystic Ovary Syndrome)

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 40 Years
Healthy Volunteers
Accepted

Interventions

  • Traditional Letrozole Therapy — DRUG
    Traditional therapy group: 5 mg/day of letrozole for 5 days (cycle days 2-6).
  • Extended Letrozole Therapy — DRUG
    Extended therapy group: 5 mg/day of letrozole for 10 days (cycle days 2-12)

Study Details

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).

Key Dates

First listed
Sep 8, 2025
Start date
Sep 1, 2025
Status verified
Nov 2025
Primary completion
Jul 30, 2026
Completion
Jul 30, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Traditional Letrozole Therapy
    Participants in this group will receive standard letrozole therapy for ovulation induction. Letrozole will be administered orally at a dose of 5 mg/day from cycle day 2 through cycle day 6 (5 consecutive days). Ovulation monitoring will be performed by transvaginal ultrasound and confirmed with urinary LH testing and/or corpus luteum visualization. This arm serves as the active comparator against the extended regimen for evaluating efficacy and safety outcomes.
  • Experimental: Extended Letrozole Therapy
    Participants in this group will receive extended letrozole therapy for ovulation induction. Letrozole will be administered orally at a dose of 5 mg/day from cycle day 2 through cycle day 12 (10 consecutive days). Ovulation monitoring will be performed by transvaginal ultrasound and confirmed with urinary LH testing and/or corpus luteum visualization. This arm will be compared with the standard regimen to assess differences in ovulation rate, follicular development, pregnancy outcomes, and safety.

Primary Outcome Measure

Ovulation rate [ Time Frame: Assessed within one treatment cycle (up to 6 weeks from the start of medication). ]

Central Contacts

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