Laboratory and Ultrasound Findings and Response to Letrozole in PCOS Patients

Condition(s) studied

Investigational drug(s) / intervention(s)

Letrozole tablets: The 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.

Study 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

Primary outcome measure(s)

• 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 sites (1)

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