NCT07159880 Letrozole Extended vs Traditional Therapy for Ovulation Induction in Women With PCOS (PROLEx-PCOS)

Trial Parameters

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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 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 Criteria

Inclusion Criteria: * 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 Criteria: * 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.

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