Longer Versus Standard Letrozole Dosing to Trigger Ovulation in PCOS
Compares two letrozole treatment lengths to help ovulation in women with PCOS.
Plain-language title generated from the registry record
Registry title: Letrozole Extended vs Traditional Therapy for Ovulation Induction in Women With PCOS (PROLEx-PCOS)
Key facts
- Where
- São Paulo, BrazilSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for women aged 18 to 40 with polycystic ovary syndrome (PCOS) who want to become pregnant. It compares 10 days of letrozole with 5 days.
- Age
- 18 to 40 years
- Sex
- Women only
- Disease stage
- Polycystic ovary syndrome (PCOS) diagnosed by the Rotterdam criteria (2003): at least two of these three signs: rare or no ovulation, high male-type hormones (clinical or in blood tests), polycystic ovaries on ultrasound.
- Biomarker or test result
- BMI between 18,5 and 31 kg/m2
Main reasons for not taking part
- Blocked fallopian tubes on both sides (confirmed), severe male-factor infertility, or premature ovarian insufficiency
- Uncontrolled high prolactin or thyroid problem
- Uterine malformations (present from birth or acquired)
- History of gynecologic or breast cancer
- Known allergy to letrozole or a reason it cannot be used
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 40 years old?
Source: NCT07159880, who can take part
Where in Brazil
- Health Complex Dr Wladimir ArrudaSão Paulo, BrazilContact: Gabriel M Pinheiro, MDTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- GABRIEL MONTEIRO PINHEIRO
- Trial code
- NCT07159880
- Record updated
- 28 November 2025
- Original description
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).Read full original descriptionShow less
Extended Therapy Versus Traditional Therapy With Letrozole for Ovulation Induction in Women With Polycystic Ovary Syndrome: A Randomized Controlled Trial
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).
Inclusion: 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: 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 <18 or >40 years; Congenital or acquired uterine malformations; Pregnancy or breastfeeding at the time of screening.