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
This trial does not accept healthy volunteersQualifiers
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 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Letrozole tablets
DrugThe 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.
Treatment groups
138 Participants
are divided into 1 treatment groupGroup A: PCOS patients1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
At the end of cycle 3 of treatment (each cycle is 28 days).2
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.
Time frame
At the end of cycle 3 of treatment (each cycle is 28 days).3
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.
Time frame
At the end of cycle 3 of treatment (each cycle is 28 days).4
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.
Time frame
At the end of cycle 3 of treatment (each cycle is 28 days).Sponsors and contacts
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Source ClinicalTrials.gov
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