Letrozole Extended vs Traditional Therapy for Ovulation Induction in Women With PCOS (PROLEx-PCOS)

NCT ID: NCT07159880

Last Updated: 2025-11-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2026-07-30

Brief Summary

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.

Conditions

PCOS (Polycystic Ovary Syndrome); Infertility; Anovulation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Traditional Letrozole Therapy

Participants in this group will receive standard letrozole therapy for ovulation induction. Letrozole will be administered orally at a dose of 5 mg/day from cycle day 2 through cycle day 6 (5 consecutive days). Ovulation monitoring will be performed by transvaginal ultrasound and confirmed with urinary LH testing and/or corpus luteum visualization. This arm serves as the active comparator against the extended regimen for evaluating efficacy and safety outcomes.

Group Type: ACTIVE_COMPARATOR

Traditional Letrozole Therapy

Intervention Type: DRUG

Traditional therapy group: 5 mg/day of letrozole for 5 days (cycle days 2-6).

Extended Letrozole Therapy

Participants in this group will receive extended letrozole therapy for ovulation induction. Letrozole will be administered orally at a dose of 5 mg/day from cycle day 2 through cycle day 12 (10 consecutive days). Ovulation monitoring will be performed by transvaginal ultrasound and confirmed with urinary LH testing and/or corpus luteum visualization. This arm will be compared with the standard regimen to assess differences in ovulation rate, follicular development, pregnancy outcomes, and safety.

Group Type: EXPERIMENTAL

Extended Letrozole Therapy

Intervention Type: DRUG

Extended therapy group: 5 mg/day of letrozole for 10 days (cycle days 2-12)

Interventions

Traditional Letrozole Therapy

Traditional therapy group: 5 mg/day of letrozole for 5 days (cycle days 2-6).

Intervention Type: DRUG

Extended Letrozole Therapy

Extended therapy group: 5 mg/day of letrozole for 10 days (cycle days 2-12)

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

GABRIEL MONTEIRO PINHEIRO

OTHER

Sponsor Role: lead

Responsible Party

GABRIEL MONTEIRO PINHEIRO

Study Director, Obstetrician and Gynecologist, Department of Obstetrics and Gynecology, Hospital Wladimir Arruda; Professor of Obstetrics and Gynecology, University of Santo Amaro (UNISA)

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Gabriel M Pinheiro, MD

Role: STUDY_DIRECTOR

University of Santo Amaro

Katherine Ann R Miller, Medical student

Role: PRINCIPAL_INVESTIGATOR

Universisty of Santo Amaro

Locations

Health Complex Dr Wladimir Arruda

São Paulo, São Paulo, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Katherine Ann R Miller, Medical student

Role: CONTACT

katherinereimao000@gmail.com

+55(11) 964098358

Gabriel M Pinheiro, MD

Role: CONTACT

Drg.monteiro@hotmail.com

+55(11) 97130-7240

Facility Contacts

Gabriel M Pinheiro, MD

Role: primary

Drg.monteiro@hotmail.com

+55(11)97130-7240

Katherine Ann R Miller, Undergraduate medical student

Role: backup

katherinereimao000@gmail.com

+55 (11) 96409-8358

Other Identifiers

88592925.0.0000.0081

Identifier Type: -

Identifier Source: org_study_id