Laboratory and Ultrasound Findings and Response to Letrozole in PCOS Patients

Al-Azhar University

Status: Not yet enrolling

Conditions: PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries

Treatments: Drug: Letrozole tablets

Study type: Observational

Funder types: Other

Identifiers

NCT06861803

Gyne19225

Details and patient eligibility

About

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.

Enrollment: 138 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

138 participants in 1 patient group

PCOS patients

Description:

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.

Treatment:

Drug: Letrozole tablets