Effects of Letrozole During the Luteal Phase After Controlled Ovarian Stimulation in Oocyte Donors.
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: Administration of letrozole.
- Кому может быть актуально
- Состояния в реестре: Luteinised Follicular Cyst. Базовые параметры: 18 лет — 34 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
- Испания
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Clinical and Endocrinological Effects of Letrozole During the Luteal Phase After Controlled Ovarian Stimulation in Oocyte Donors: a Low Interventional, Randomized, Controlled Trial
Обзор
The objective of this trial is to determine whether the use of letrozole during the luteal phase in oocyte donors diminishes the ovarian volume, as well as to evaluate its effect on the duration of the luteal phase, taking into account hormonal and biochemical markers. Two groups will be established with random allocation of patients and 1:1 proportionality, as follows: * Control group: No specific treatment. * Study group: Oral administration of letrozole 5 mg (each capsule is 2.5 mg) once a day for 5 days starting on the night of the follicular puncture.
Подробное описание
Letrozole is a widely used drug in the context of hormone-dependent malignant tumors due to its antiestrogenic effect. Its mechanism of action allows its application to the field of Assisted Reproductive Medicine, mainly as an inductor of ovulation, by means of a blockage in the negative feedback signalization of the hypothalamus-pituitary-gonadal axis. In the last years, it has also been tested with the goals of preventing ovarian hyperstimulation syndrome (OHSS) or analyzing its effects on several endocrinological and biochemical markers such as LH, progesterone or VEGF. However, the results are inconsistent on every account. Data regarding the effect on ovarian size and the duration of the luteal phase following the administration of letrozole after the oocyte pick-up can be useful to evaluate the benefit of this drug in patients with a tendency towards hyperresponse, in which both the discomfort after the stimulation and the risk of ovarian torsion are increased.
The objective of this trial is to determine whether the use of letrozole during the luteal phase in oocyte donors diminishes the ovarian volume, as well as to evaluate its effect on the duration of the luteal phase, taking into account hormonal and biochemical markers
Вмешательства
- Препарат Administration of letrozole
Oral administration of letrozole 5 mg (each capsule is 2.5 mg) once a day for 5 days starting on the night of the follicular puncture.
Первичные конечные точки
- To determine ovarian volume in millilitres in oocyte donors according to whether or not they receive the treatment during the luteal phase after ovarian stimulation. [Срок оценки: On the day of ovarian puncture, 5 days post-puncture and 10 days post-puncture.]
Вторичные конечные точки (2)
- To determine the levels of VEGF, VEGF/sFlt-1 ratio, LH, FSH, oestradiol, progesterone and testosterone in the plasma of oocyte donors depending on whether or not they receive the study treatment during the luteal phase. [Срок оценки: On the day of ovarian puncture, 5 days post-puncture and 10 days post-puncture.]
- To determine the duration of the luteal phase in oocyte donors depending on whether or not they receive the treatment under study during the luteal phase after ovarian stimulation. [Срок оценки: On the day of ovarian puncture and 10 days post-puncture.]
Критерии участия
Критерии включения
- Hyper-responsiveness to stimulation, defined as the presence of ≥18 follicles of size ≥11 mm (22-24) on the day of the last ultrasound visit prior to ovarian puncture.
Критерии исключения
- Participation in another clinical study, prior to inclusion in the present study, that could affect the objectives of this study.
- Known allergy to letrozole.
- Known lactose intolerance.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Испания · 1 центр
- IVI-Madrid — Madrid
Идентификаторы
NCT: NCT06244745 · 2206-MAD-089-SC