NCT07159880 Letrozole Extended vs Traditional Therapy for Ovulation Induction in Women With PCOS (PROLEx-PCOS)
| NCT ID | NCT07159880 |
| Status | Recruiting |
| Phase | — |
| Sponsor | GABRIEL MONTEIRO PINHEIRO |
| Condition | PCOS (Polycystic Ovary Syndrome) |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-09-01 |
| Primary Completion | 2026-07-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2025-09-01 with a primary completion date of 2026-07-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
Gabriel M Pinheiro, MD
STUDY DIRECTOR
Universidade Santo Amaro
Frequently Asked Questions
Who can join the NCT07159880 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 40 Years, studying PCOS (Polycystic Ovary Syndrome). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07159880 currently recruiting?
Yes, NCT07159880 is actively recruiting participants. Contact the research team at katherinereimao000@gmail.com for enrollment information.
Where is the NCT07159880 trial being conducted?
This trial is being conducted at São Paulo, Brazil.
Who is sponsoring the NCT07159880 clinical trial?
NCT07159880 is sponsored by GABRIEL MONTEIRO PINHEIRO. The principal investigator is Gabriel M Pinheiro, MD at Universidade Santo Amaro. The trial plans to enroll 20 participants.