Laboratory and Ultrasound Findings and Response to Letrozole in PCOS Patients

Not yet recruiting

• Conditions: PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries
• Interventions: Drug: Letrozole tablets

• Registration Number: NCT06861803
• Lead Sponsor: Al-Azhar University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-18
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-02
• Study First Posted: 2025-03-06
• Last Update Submitted: 2025-03-20
• Last Update Posted: 2025-03-21
• Study Start: 2025-04-01
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 138

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PCOS patients	Letrozole tablets	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.

Primary Outcome Measures

Name	Time	Method
Comparison of baseline FSH level between letrozole-sensitive and letrozole-resistant PCOS patients.	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.
Comparison of baseline LH level between letrozole-sensitive and letrozole-resistant PCOS patients.	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.
Comparison of 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).	This outcome measures the differences in baseline LH/FSH ratio level between letrozole-sensitive and letrozole-resistant PCOS patients.
Comparison of baseline AMH level between letrozole-sensitive and letrozole-resistant PCOS patients.	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.
Comparison of 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).	This outcome measures the differences in baseline total testosterone level between letrozole-sensitive and letrozole-resistant PCOS patients.
Comparison of 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).	This outcome measures the differences in baseline fasting insulin level between letrozole-sensitive and letrozole-resistant PCOS patients.
Comparison of baseline glucose level between letrozole-sensitive and letrozole-resistant PCOS patients.	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.
Comparison of baseline lipid profile between letrozole-sensitive and letrozole-resistant PCOS patients.	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.
Comparison of 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)	This outcome measures the differences in baseline antral follicle count between letrozole-sensitive and letrozole-resistant PCOS patients.
Comparison of baseline ovarian volume between letrozole-sensitive and letrozole-resistant PCOS patients.	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.

Trial Locations

Locations (1)

Al-Hussein University Hospital; 🇪🇬 Cairo, Egypt