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Not yet recruiting NCT06861803

Laboratory and Ultrasound Findings and Response to Letrozole in PCOS Patients

— Observational PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Letrozole tablets.
Who it may be relevant to
Registry conditions: PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries. Basic parameters: 18 years — 40 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Drug 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 ultras

Primary outcome measures

  • 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).]
  • 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).]
  • 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).]
  • 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).]
  • 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).]
  • 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).]
  • 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).]
  • 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).]
  • 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)]
  • 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)]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Egypt · 1 center
  • Al-Hussein University Hospital — Cairo

Identifiers

NCT: NCT06861803 · Gyne19225

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗