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NCT Number: NCT06861803

Laboratory and Ultrasound Findings and Response to Letrozole in PCOS Patients

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.

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Key information

Conditions

PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Polycystic Ovary Syndrome Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Al-Hussein University Hospital

Cairo, 11633, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Letrozole tablets

Drug

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.

Primary outcomes

  1. Comparison of 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).

    This outcome measures the differences in baseline FSH level between letrozole-sensitive and letrozole-resistant PCOS patients.

  2. Comparison of 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).

    This outcome measures the differences in baseline LH level between letrozole-sensitive and letrozole-resistant PCOS patients.

  3. Comparison of 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).

    This outcome measures the differences in baseline LH/FSH ratio level between letrozole-sensitive and letrozole-resistant PCOS patients.

  4. Comparison of 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).

    This outcome measures the differences in baseline AMH level between letrozole-sensitive and letrozole-resistant PCOS patients.

  5. Comparison of baseline total testosterone level between letrozole-sensitive and letrozole-resistant PCOS patients.

    Time frame: 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.

  6. Comparison of baseline fasting insulin level between letrozole-sensitive and letrozole-resistant PCOS patients.

    Time frame: 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.

  7. Comparison of baseline glucose level between letrozole-sensitive and letrozole-resistant PCOS patients.

    Time frame: 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.

  8. Comparison of baseline lipid profile between letrozole-sensitive and letrozole-resistant PCOS patients.

    Time frame: 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.

  9. Comparison of baseline antral follicle count between letrozole-sensitive and letrozole-resistant PCOS patients.

    Time frame: 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.

  10. Comparison of baseline ovarian volume between letrozole-sensitive and letrozole-resistant PCOS patients.

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Muhamed Alhagrasy

CONTACT

[email protected]

01017313413

Muhamed Alhagrasy, M.D.

CONTACT

[email protected]

01017313413

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

Comparison of Laboratory and Ultrasound Findings Between Letrozole-Resistant and Letrozole-Sensitive PCOS Patients in Egypt

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 6, 2025
Registry last updated
Mar 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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