Laboratory and Ultrasound Findings and Response to Letrozole in PCOS Patients

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-40
SponsorAl-Azhar University

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Treatments tested in this trial

  • Letrozole tablets

Treatment groups

138 Participants
are divided into 1 treatment group

Sponsors and collaborators