Extended vs standard letrozole for ovulation induction in women with PCOS.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized trial will enroll 84 women aged 18–40 with PCOS and assign them to either an extended letrozole regimen (5 mg daily from cycle day 2–12) or the standard regimen (5 mg daily from cycle day 2–6). Ovulatory response will be tracked with serial transvaginal ultrasound, urinary LH testing, and assessment of corpus luteum formation. The primary outcome is ovulation rate, with secondary outcomes including number and size of mature follicles, clinical pregnancy rate, multiple pregnancy rate, miscarriage rate, cycles to pregnancy, and incidence of OHSS. Safety and tolerability of the extended schedule will be monitored throughout treatment.

Why it matters

Who can join: the full rules

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.

Where it's running

• Health Complex Dr Wladimir Arruda
  São Paulo, São Paulo, Brazil Recruiting

Study contacts

• Principal investigator: Katherine Ann R Miller, Medical student — Universisty of Santo Amaro
• Study coordinator: Katherine Ann R Miller, Medical student
• Email: katherinereimao000@gmail.com
• Phone: +55(11) 964098358

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.