Status:
RECRUITING
Letrozole Extended vs Traditional Therapy for Ovulation Induction in Women With PCOS (PROLEx-PCOS)
Lead Sponsor:
GABRIEL MONTEIRO PINHEIRO
Conditions:
PCOS (Polycystic Ovary Syndrome)
Infertility
Eligibility:
FEMALE
18-40 years
Phase:
NA
Brief 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 induct...
Detailed Description
Polycystic ovary syndrome (PCOS) is a prevalent endocrine disorder and one of the leading causes of anovulatory infertility worldwide. Letrozole, an aromatase inhibitor, has emerged as the preferred f...
Eligibility Criteria
Inclusion
- Women aged 18 to 40 years;
- BMI between 18,5 and 31 kg/m2
- Diagnosis of Polycystic Ovary Syndrome (PCOS) according to the Rotterdam criteria (2003) (presence of at least two of the following: oligo/anovulation, clinical and/or biochemical hyperandrogenism, polycystic ovarian morphology on ultrasound);
- Active desire for pregnancy at the time of enrollment;
- Ability and willingness to provide written informed consent (ICF).
Exclusion
- Age \<18 or \>40 years;
- Presence of confirmed bilateral tubal factor, severe male factor infertility, premature ovarian insufficiency, uncontrolled hyperprolactinemia or thyroid dysfunction);
- Congenital or acquired uterine malformations;
- History of gynecologic or breast cancer;
- Known hypersensitivity to, or contraindication for, letrozole;
- Severe uncontrolled systemic disease (e.g., cardiovascular, renal, or hepatic disorders);
- Pregnancy or breastfeeding at the time of screening.
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 30 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT07159880
Start Date
September 1 2025
End Date
July 30 2026
Last Update
November 28 2025
Active Locations (1)
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1
Health Complex Dr Wladimir Arruda
São Paulo, São Paulo, Brazil, 04829-310