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

NCT07159880 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-11-28

No results posted yet for this study

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).

Conditions

  • PCOS (Polycystic Ovary Syndrome)
  • Infertility
  • Anovulation

Interventions

DRUG

Traditional Letrozole Therapy

Traditional therapy group: 5 mg/day of letrozole for 5 days (cycle days 2-6).

DRUG

Extended Letrozole Therapy

Extended therapy group: 5 mg/day of letrozole for 10 days (cycle days 2-12)

Sponsors & Collaborators

  • GABRIEL MONTEIRO PINHEIRO

    lead OTHER

Principal Investigators

  • Gabriel M Pinheiro, MD · University of Santo Amaro

  • Katherine Ann R Miller, Medical student · Universisty of Santo Amaro

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2026-07-30
Completion
2026-07-30

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07159880 on ClinicalTrials.gov