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

NCT07159880 | Recruiting DMC

• 1 other identifier: 88592925.0.0000.0081
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

PCOS (Polycystic Ovary Syndrome); Infertility; Anovulation

Keywords

polycystic ovary syndrome; PCOS; Ovulation induction; Letrozole; Aromatase Inhibitor; Extended letrozole therapy; traditional letrozole therapy; standart letrozole therapy; infertility; anovulation; ovulation rate; pregnancy rate

Outcome Measures

Primary Outcomes (1)

• Ovulation rate

  Proportion of participants achieving ovulation, defined as the presence of a dominant follicle ≥18 mm on transvaginal ultrasound with confirmation by urinary LH surge and/or visualization of corpus luteum.

  Assessed within one treatment cycle (up to 6 weeks from the start of medication).

Secondary Outcomes (6)

• Clinical Pregnancy Rate

  Assessed within 8 weeks after the start of treatment.

• Number of Mature Follicles

  Assessed during one treatment cycle (up to 6 weeks).

• Follicular Size

  Assessed during one treatment cycle (up to 6 weeks).

• Miscarriage Rate

  Assessed up to 12 weeks of gestation.

• Multiple Pregnancy Rate

  Assessed within 8 weeks after the start of treatment.

Study Arms (2)

Traditional Letrozole Therapy

ACTIVE COMPARATOR

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.

Drug: Traditional Letrozole Therapy

Extended Letrozole Therapy

EXPERIMENTAL

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.

Drug: Extended Letrozole Therapy

Interventions

Traditional Letrozole Therapy DRUG

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

Traditional Letrozole Therapy

Extended Letrozole Therapy DRUG

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

Extended Letrozole Therapy

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• GABRIEL MONTEIRO PINHEIRO: lead

Study Sites (1)

Health Complex Dr Wladimir Arruda

São Paulo, São Paulo, 04829-310, Brazil

RECRUITING

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Infertility; Anovulation

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Officials

• Gabriel M Pinheiro, MD

  University of Santo Amaro

  STUDY DIRECTOR

• Katherine Ann R Miller, Medical student

  Universisty of Santo Amaro

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katherine Ann R Miller, Medical student

CONTACT

+55(11) 964098358; katherinereimao000@gmail.com

Gabriel M Pinheiro, MD

CONTACT

+55(11) 97130-7240; Drg.monteiro@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Study Director, Obstetrician and Gynecologist, Department of Obstetrics and Gynecology, Hospital Wladimir Arruda; Professor of Obstetrics and Gynecology, University of Santo Amaro (UNISA)

Model Details: This is a randomized, controlled, parallel assignment clinical trial designed to compare extended letrozole therapy with standard letrozole therapy for ovulation induction in women with polycystic ovary syndrome (PCOS). Participants will be randomized in a 1:1 ratio into two groups: extended therapy (letrozole 5 mg/day from cycle days 2-12) and standard therapy (letrozole 5 mg/day from cycle days 2-6). Ovulation will be monitored by transvaginal ultrasound and confirmed with urinary LH testing. The primary outcome is ovulation rate. Secondary outcomes include number and size of mature follicles, clinical pregnancy rate, miscarriage rate, multiple pregnancy rate, time to conception, and incidence of ovarian hyperstimulation syndrome (OHSS).

Study Record Dates

• First Submitted: August 29, 2025
• First Posted: September 8, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• Time Frame: Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
• Access Criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided only in accordance with participants' informed consent (ICF). For more information or to submit a request, please contact katherinereimao000@gmail.com

Locations

BR (1)