Clinical trial NCT06861803: Laboratory and Ultrasound Findings and Response to Letrozole in PCOS Patients
Official title: Comparison of Laboratory and Ultrasound Findings Between Letrozole-Resistant and Letrozole-Sensitive PCOS Patients in Egypt
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries
Keywords: PCOS
letrozole
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2025-03-06
Enrollment: 138
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Comparison of baseline FSH level between letrozole-sensitive and letrozole-resistant PCOS patients.
timeFrame: At the end of cycle 3 of treatment (each cycle is 28 days).
measure: Comparison of baseline LH level between letrozole-sensitive and letrozole-resistant PCOS patients.
timeFrame: At the end of cycle 3 of treatment (each cycle is 28 days).
measure: Comparison of baseline LH/FSH ratio level between letrozole-sensitive and letrozole-resistant PCOS patients.
timeFrame: At the end of cycle 3 of treatment (each cycle is 28 days).
measure: Comparison of baseline AMH level between letrozole-sensitive and letrozole-resistant PCOS patients.
timeFrame: At the end of cycle 3 of treatment (each cycle is 28 days).
measure: Comparison of baseline total testosterone level between letrozole-sensitive and letrozole-resistant PCOS patients.
timeFrame: At the end of cycle 3 of treatment (each cycle is 28 days).
measure: Comparison of baseline fasting insulin level between letrozole-sensitive and letrozole-resistant PCOS patients.
timeFrame: At the end of cycle 3 of treatment (each cycle is 28 days).
measure: Comparison of baseline glucose level between letrozole-sensitive and letrozole-resistant PCOS patients.
timeFrame: At the end of cycle 3 of treatment (each cycle is 28 days).
measure: Comparison of baseline lipid profile between letrozole-sensitive and letrozole-resistant PCOS patients.
timeFrame: At the end of cycle 3 of treatment (each cycle is 28 days).
measure: Comparison of baseline antral follicle count between letrozole-sensitive and letrozole-resistant PCOS patients.
timeFrame: At the end of cycle 3 of treatment (each cycle is 28 days)
measure: Comparison of baseline ovarian volume between letrozole-sensitive and letrozole-resistant PCOS patients.
timeFrame: At the end of cycle 3 of treatment (each cycle is 28 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Al-Hussein University Hospital
Study officials:
affiliation: Al-Azhar University
name: Muhamed Alhagrasy, M.D.
role: PRINCIPAL_INVESTIGATOR
References: