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Набор скоро начнётся NCT06861803

Laboratory and Ultrasound Findings and Response to Letrozole in PCOS Patients

— Наблюдательное PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Letrozole tablets.
Кому может быть актуально
Состояния в реестре: PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries. Базовые параметры: 18 лет — 40 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Египет
Следующий шаг
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Официальное название

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

Обзор

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.

Вмешательства

  • Препарат 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

Первичные конечные точки

  • Comparison of baseline FSH level between letrozole-sensitive and letrozole-resistant PCOS patients. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: At the end of cycle 3 of treatment (each cycle is 28 days)]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Египет · 1 центр
  • Al-Hussein University Hospital — Cairo

Идентификаторы

NCT: NCT06861803 · Gyne19225

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗