Letrozole Extended vs Traditional Therapy for Ovulation Induction in Women With PCOS (PROLEx-PCOS)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Traditional Letrozole Therapy, Extended Letrozole Therapy.
- Who it may be relevant to
- Registry conditions: PCOS (Polycystic Ovary Syndrome), Infertility, Anovulation. Basic parameters: 18 years — 40 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Extended Therapy Versus Traditional Therapy With Letrozole for Ovulation Induction in Women With Polycystic Ovary Syndrome: A Randomized Controlled Trial
Overview
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).
Detailed description
Polycystic ovary syndrome (PCOS) is a prevalent endocrine disorder and one of the leading causes of anovulatory infertility worldwide. Letrozole, an aromatase inhibitor, has emerged as the preferred first-line pharmacological agent for ovulation induction in women with PCOS. Despite its widespread use, there is ongoing debate regarding the optimal duration of therapy to maximize ovulatory and pregnancy outcomes.
This randomized clinical trial is designed to evaluate whether an extended regimen of letrozole provides superior reproductive outcomes compared with the standard regimen. The extended protocol consists of daily administration of 5 mg letrozole from cycle day 2 through day 12, whereas the standard regimen involves 5 mg daily from cycle day 2 through day 6. Ovulatory response will be monitored through serial transvaginal ultrasound and biochemical markers of ovulation.
The trial aims to generate high-quality evidence on the efficacy and safety of extended letrozole therapy. The findings may inform future clinical guidelines on ovulation induction strategies in women with PCOS and contribute to optimizing treatment protocols for anovulatory infertility.
Interventions
- Drug Traditional Letrozole Therapy
Traditional therapy group: 5 mg/day of letrozole for 5 days (cycle days 2-6). - Drug Extended Letrozole Therapy
Extended therapy group: 5 mg/day of letrozole for 10 days (cycle days 2-12)
Primary outcome measures
- Ovulation rate [Time frame: Assessed within one treatment cycle (up to 6 weeks from the start of medication).]
Secondary outcome measures (6)
- Clinical Pregnancy Rate [Time frame: Assessed within 8 weeks after the start of treatment.]
- Number of Mature Follicles [Time frame: Assessed during one treatment cycle (up to 6 weeks).]
- Follicular Size [Time frame: Assessed during one treatment cycle (up to 6 weeks).]
- Miscarriage Rate [Time frame: Assessed up to 12 weeks of gestation.]
- Multiple Pregnancy Rate [Time frame: Assessed within 8 weeks after the start of treatment.]
- Incidence of Ovarian Hyperstimulation Syndrome (OHSS) [Time frame: Assessed within one treatment cycle (up to 6 weeks).]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Brazil · 1 center
- Health Complex Dr Wladimir Arruda — São Paulo
Identifiers
NCT: NCT07159880 · 88592925.0.0000.0081