NCT07159880Recruiting
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
Source: ClinicalTrials.gov · Last updated 28 Nov 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 29 Aug 2025
- Start date
- 1 Sept 2025
- Primary completion date
- 30 Jul 2026
- Lead sponsor
- GABRIEL MONTEIRO PINHEIRO
- NCT number
- NCT07159880
What you commit to
- Study type: Interventional
- Planned participants: 20
- From 1 Sept 2025 to the primary completion date, 30 Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Presence of confirmed bilateral tubal factor, severe male factor infertility, premature ovarian insufficiency, uncontrolled hyperprolactinemia or thyroid dysfunction);
- History of gynecologic or breast cancer;
- Known hypersensitivity to, or contraindication for, letrozole;
- Severe uncontrolled systemic disease (e.g., cardiovascular, renal, or hepatic disorders);
Age
- Age \<18 or \>40 years;
Other
- Congenital or acquired uterine malformations;
- Pregnancy or breastfeeding at the time of screening.
Who the study is looking for
- 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).
Age in the registry: 18 years to 40 years · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Health Complex Dr Wladimir Arruda Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.