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

Extended Therapy Versus Traditional Therapy With Letrozole for Ovulation Induction in Women With Polycystic Ovary Syndrome: A Randomized Controlled Trial

This test will see if taking letrozole for 10 days helps women with PCOS ovulate and get pregnant better than the usual 5-day course.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 40 Years
• Sex: Female
• Sponsor: Embrionare (Academic / other)
• Locations: 1 site (São Paulo, São Paulo)
• Trial ID: NCT07159880 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Women 18–40 years old with PCOS by Rotterdam criteria, BMI 18.5–31 kg/m2, actively trying to conceive and able to provide informed consent.

Not a fit: Women with confirmed bilateral tubal blockage, severe male-factor infertility, premature ovarian insufficiency, known contraindication to letrozole, uncontrolled systemic disease, pregnancy, or current breastfeeding are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, extended letrozole could raise ovulation and pregnancy rates for women with PCOS without substantially increasing adverse effects.

How similar studies have performed: Letrozole is established as a first-line ovulation agent, but using an extended 10-day dosing period is a relatively novel approach with limited and mixed prior evidence.

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.

Where this trial is running

São Paulo, São Paulo

• 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

Conditions PCOS; Infertility; Anovulation; polycystic ovary syndrome; Ovulation induction; Letrozole; Aromatase Inhibitor; Extended letrozole therapy