Laboratory and Ultrasound Findings and Response to Letrozole in PCOS Patients

NCT06861803 | Not Yet Recruiting

• 1 other identifier: Gyne19225
• Study Type: observational
• Target: 138
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

PCOS; letrozole

Outcome Measures

Primary Outcomes (10)

• Comparison of baseline FSH level between letrozole-sensitive and letrozole-resistant PCOS patients.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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)

Study Arms (1)

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

Interventions

Letrozole tablets DRUG

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.

PCOS patients

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: This study will include female participants only, as it focuses on women diagnosed with polycystic ovary syndrome (PCOS) who are undergoing ovulation induction with letrozole for infertility treatment. Male participants are not eligible for this study.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Al-Hussein University Hospital

Cairo, 11633, Egypt

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Letrozole

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

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Muhamed Alhagrasy, M.D.

  Al-Azhar University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhamed Alhagrasy, M.D.

CONTACT

01017313413; MuhamedAhmed.216@azhar.edu.eg

Muhamed Alhagrasy

CONTACT

01017313413; MuhamedAhmed.216@azhar.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer and consultant at Obstetrics and Gynecology Department.

Study Record Dates

• First Submitted: February 18, 2025
• First Posted: March 6, 2025
• Study Start: April 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 30, 2025
• Last Updated: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The data will be available six months after study completion and will remain accessible for a period of five years.
• 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.

Locations

EG (1)