Laboratory and Ultrasound Findings and Response to Letrozole in PCOS Patients

March 20, 2025 updated by: Muhamed Ahmed Abdelmoaty Muhamed Alhagrasy, Al-Azhar University

Comparison of Laboratory and Ultrasound Findings Between Letrozole-Resistant and Letrozole-Sensitive PCOS Patients in Egypt

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

138

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Cairo, Egypt, 11633
        • Al-Hussein University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study will include women diagnosed with polycystic ovary syndrome (PCOS) based on the Rotterdam criteria, who are seeking infertility treatment and undergoing ovulation induction with letrozole for the first time. Participants will be women aged 18-40 years, recruited from the outpatient clinic at Al-Hussein University Hospital, a tertiary healthcare center in Egypt. All participants will undergo a comprehensive baseline assessment, including clinical evaluation, laboratory investigations, and transvaginal ultrasound before starting letrozole treatment. The study aims to identify potential predictors of letrozole resistance by comparing baseline characteristics between women who respond to treatment and those who do not.

Description

Inclusion Criteria:

  • Women aged 18-40 years.
  • Diagnosis of PCOS based on Rotterdam criteria.
  • No prior ovulation induction with letrozole.
  • Willing to follow the treatment protocol and attend follow-up visits

Exclusion Criteria:

  • Infertility due to other causes such as tubal obstruction or male factor infertility.
  • Previous ovarian surgery or use of medications that could influence ovulation.
  • Comorbidities such as uncontrolled diabetes, hyperprolactinemia, or thyroid dysfunction.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
PCOS patients
The study will include a single group of women diagnosed with polycystic ovary syndrome (PCOS) based on the Rotterdam criteria, who are undergoing ovulation induction with letrozole for the first time. Participants will be women aged 18-40 years attending the outpatient clinic at Al-Hussein University Hospital for infertility treatment. All participants will undergo a comprehensive baseline assessment, including clinical evaluation, laboratory investigations, and transvaginal ultrasound before starting letrozole therapy. After treatment, they will be classified into letrozole-sensitive or letrozole-resistant subgroups based on their ovulatory response. The study aims to identify potential predictors of letrozole resistance by comparing baseline characteristics between these two outcome-based subgroups.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of baseline FSH level between letrozole-sensitive and letrozole-resistant PCOS patients.
Time Frame: At the end of cycle 3 of treatment (each cycle is 28 days).
This outcome measures the differences in baseline FSH level between letrozole-sensitive and letrozole-resistant PCOS patients.
At the end of cycle 3 of treatment (each cycle is 28 days).
Comparison of baseline LH level between letrozole-sensitive and letrozole-resistant PCOS patients.
Time Frame: At the end of cycle 3 of treatment (each cycle is 28 days).
This outcome measures the differences in baseline LH level between letrozole-sensitive and letrozole-resistant PCOS patients.
At the end of cycle 3 of treatment (each cycle is 28 days).
Comparison of baseline LH/FSH ratio level between letrozole-sensitive and letrozole-resistant PCOS patients.
Time Frame: At the end of cycle 3 of treatment (each cycle is 28 days).
This outcome measures the differences in baseline LH/FSH ratio level between letrozole-sensitive and letrozole-resistant PCOS patients.
At the end of cycle 3 of treatment (each cycle is 28 days).
Comparison of baseline AMH level between letrozole-sensitive and letrozole-resistant PCOS patients.
Time Frame: At the end of cycle 3 of treatment (each cycle is 28 days).
This outcome measures the differences in baseline AMH level between letrozole-sensitive and letrozole-resistant PCOS patients.
At the end of cycle 3 of treatment (each cycle is 28 days).
Comparison of baseline total testosterone level between letrozole-sensitive and letrozole-resistant PCOS patients.
Time Frame: At the end of cycle 3 of treatment (each cycle is 28 days).
This outcome measures the differences in baseline total testosterone level between letrozole-sensitive and letrozole-resistant PCOS patients.
At the end of cycle 3 of treatment (each cycle is 28 days).
Comparison of baseline fasting insulin level between letrozole-sensitive and letrozole-resistant PCOS patients.
Time Frame: At the end of cycle 3 of treatment (each cycle is 28 days).
This outcome measures the differences in baseline fasting insulin level between letrozole-sensitive and letrozole-resistant PCOS patients.
At the end of cycle 3 of treatment (each cycle is 28 days).
Comparison of baseline glucose level between letrozole-sensitive and letrozole-resistant PCOS patients.
Time Frame: At the end of cycle 3 of treatment (each cycle is 28 days).
This outcome measures the differences in baseline glucose level between letrozole-sensitive and letrozole-resistant PCOS patients.
At the end of cycle 3 of treatment (each cycle is 28 days).
Comparison of baseline lipid profile between letrozole-sensitive and letrozole-resistant PCOS patients.
Time Frame: At the end of cycle 3 of treatment (each cycle is 28 days).
This outcome measures the differences in baseline lipid profile between letrozole-sensitive and letrozole-resistant PCOS patients.
At the end of cycle 3 of treatment (each cycle is 28 days).
Comparison of baseline antral follicle count between letrozole-sensitive and letrozole-resistant PCOS patients.
Time Frame: At the end of cycle 3 of treatment (each cycle is 28 days)
This outcome measures the differences in baseline antral follicle count between letrozole-sensitive and letrozole-resistant PCOS patients.
At the end of cycle 3 of treatment (each cycle is 28 days)
Comparison of baseline ovarian volume between letrozole-sensitive and letrozole-resistant PCOS patients.
Time Frame: At the end of cycle 3 of treatment (each cycle is 28 days)
This outcome measures the differences in baseline ovarian volume between letrozole-sensitive and letrozole-resistant PCOS patients.
At the end of cycle 3 of treatment (each cycle is 28 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al-Azhar University

Investigators

  • Principal Investigator: Muhamed Alhagrasy, M.D., Al-Azhar University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2025

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

February 18, 2025

First Submitted That Met QC Criteria

March 2, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 20, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Gyne19225

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The study investigators will share de-identified individual participant data (IPD) related to baseline laboratory and ultrasound findings, ovulation outcomes, and relevant clinical parameters. The shared dataset will exclude any personally identifiable information to ensure participant confidentiality.

IPD Sharing Time Frame

The data will be available six months after study completion and will remain accessible for a period of five years.

IPD Sharing Access Criteria

Researchers and qualified investigators may request access to the dataset for scientific and academic purposes. Requests must be submitted to the corresponding author via email and include a research proposal outlining the intended use of the data. Access will be granted upon approval by the study team, and data users must agree to a data use agreement ensuring confidentiality and ethical use of the shared information.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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