RecruitingNot ApplicableNCT07159880

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

Extended Therapy Versus Traditional Therapy With Letrozole for Ovulation Induction in Women With Polycystic Ovary Syndrome: A Randomized Controlled Trial


Sponsor

GABRIEL MONTEIRO PINHEIRO

Enrollment

20 participants

Start Date

Sep 1, 2025

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This trial compares two ways of using letrozole (a medication that stimulates egg release) to help women with Polycystic Ovary Syndrome (PCOS) get pregnant: the traditional shorter course vs. an extended course over more days. The goal is to find the most effective approach for triggering ovulation. **You may be eligible if...** - You are a woman between 18 and 40 years old - You have a confirmed diagnosis of PCOS - Your BMI is between 18.5 and 31 kg/m² - You are actively trying to become pregnant - Your weight has been stable and you have no major fertility-blocking conditions in your tubes or uterus **You may NOT be eligible if...** - You have blocked fallopian tubes or severe male-factor infertility - You have premature ovarian failure or uncontrolled thyroid/prolactin problems - You have a history of gynecologic or breast cancer - You have a known allergy to letrozole - You are currently pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTraditional Letrozole Therapy

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

DRUGExtended 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

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NCT07159880


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