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Laboratory and Ultrasound Findings and Response to Letrozole in PCOS Patients

NCT06861803 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 138

Last updated 2025-03-21

No results posted yet for this study

Summary

The goal of this observational study is to compare laboratory and ultrasound findings between letrozole-resistant and letrozole-sensitive PCOS patients in Egypt. The study will include women aged 18-40 years diagnosed with PCOS based on the Rotterdam criteria, who are undergoing ovulation induction with letrozole for the first time.

The main questions it aims to answer are:

What are the baseline laboratory and ultrasound differences between letrozole-resistant and letrozole-sensitive PCOS patients? What factors can predict letrozole resistance in PCOS patients? Researchers will compare letrozole-resistant and letrozole-sensitive PCOS patients to determine whether specific laboratory markers and ultrasound findings can predict resistance to letrozole.

Participants will:

Undergo baseline clinical, laboratory, and ultrasound assessments before starting letrozole treatment.

Receive letrozole treatment with dose escalation up to 7.5 mg/day over a maximum of three cycles if ovulation is not achieved.

Be monitored through serial transvaginal ultrasounds to assess follicular development.

Have ovulation confirmed via mid-luteal serum progesterone levels. The study aims to improve the understanding of predictors of letrozole resistance to guide personalized ovulation induction strategies in PCOS patients.

Conditions

  • PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries

Interventions

DRUG

Letrozole tablets

The intervention in this study is ovulation induction using letrozole, an aromatase inhibitor commonly used in women with polycystic ovary syndrome (PCOS) to stimulate ovulation. Participants will receive letrozole at an initial dose of 2.5 mg/day for five days, starting on day 3 of the menstrual cycle. If ovulation is not achieved, the dose will be incrementally increased up to a maximum of 7.5 mg/day over a maximum of three cycles. Ovulation will be monitored through serial transvaginal ultrasounds to assess follicular development, and confirmed by measuring mid-luteal serum progesterone levels (\>3 ng/mL). Based on the response to letrozole, participants will be classified as either letrozole-sensitive (ovulatory) or letrozole-resistant (anovulatory) to identify potential predictors of resistance and improve individualized treatment strategies for PCOS-related infertility.

Sponsors & Collaborators

  • Al-Azhar University

    lead OTHER

Principal Investigators

  • Muhamed Alhagrasy, M.D. · Al-Azhar University

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-01
Primary Completion
2025-12-01
Completion
2025-12-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06861803 on ClinicalTrials.gov