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Набор скоро начнётся NCT07552493

Clinical Study on the Preservation of Ovarian Function Following Autologous Hematopoietic Stem Cell Transplantation Using Goserelin

Без фазы С лечением Ovarian Insufficiency Autologous Hematopoietic Stem Cell Transplantation

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: Goserelin 3.6 MG.
Кому может быть актуально
Состояния в реестре: Ovarian Insufficiency, Autologous Hematopoietic Stem Cell Transplantation. Базовые параметры: 14 лет — 50 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
Китай
Следующий шаг
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Обзор

This study is a prospective, multicenter, randomized controlled clinical trial planned to enroll 64 female hematologic patients aged 14 to 50 years scheduled for autologous hematopoietic stem cell transplantation (auto-HSCT). Participants will be divided into two groups based on the use of myeloablative conditioning: the myeloablative conditioning (MAC) group and the non-MAC conditioning group. The conditioning regimen for autologous hematopoietic stem cell transplantation primarily employs melphalan. A melphalan dose \>140 mg/m² constitutes myeloablative conditioning (MAC), while a dose ≤140 mg/m² is classified as non-myeloablative conditioning. Within each group, patients were randomly assigned 1:1 to the experimental group (goserelin prophylaxis) or control group using a random number table. The experimental group received a single 3.6mg subcutaneous injection of goserelin 1-3 days prior to conditioning, in addition to the standard transplantation regimen. The control group did not receive goserelin prophylaxis. The primary endpoint was menstrual recovery rate at 6 months post-transplantation (defined as ≥3 naturally occurring menstrual cycles without intervention by menstrual-regulating drugs). Secondary endpoints included: incidence of premature ovarian insufficiency (POI); ovarian reserve function markers: anti-Müllerian hormone (AMH), follicle-stimulating hormone (FSH), luteinizing hormone (LH), estradiol (E2) levels; Other reproductive parameters: ovarian and uterine volume, endometrial thickness; time to neutrophil/platelet engraftment; disease recurrence rate; transplant-related mortality; and adverse event (AE) incidence. This study aims to evaluate the efficacy of goserelin in improving ovarian function following autologous hematopoietic stem cell transplantation in hematologic malignancy patients.

Вмешательства

  • Препарат Goserelin 3.6 MG
    Subcutaneous injection of 3.6 mg of goserelin acetate once, administered 1 to 3 days prior to autologous haematopoietic stem cell transplantation conditioning.

Первичные конечные точки

  • Menstrual recovery rate six months after transplantation [Срок оценки: month 6]
Вторичные конечные точки (1)
  • Ovarian function; Safety [Срок оценки: month 6]

Критерии участия

Критерии включения

1\. Haematological patients scheduled for autologous haematopoietic stem cell transplantation; 2. Female patients aged 14 to 50 years with regular menstrual cycles prior to transplantation; 3. Patients or their legal representatives must voluntarily participate and sign an informed consent form, demonstrating comprehension and willingness to comply with all study procedures and requirements; 4. Estimated survival exceeding one year to ensure sufficient time for monitoring menstrual recovery.

Критерии исключения

1\. Patients with severe dysfunction of vital organs such as the heart, liver, or kidneys, which may compromise study outcomes or increase patient risk; 2. Patients with a history of allergy to goserelin or related medications; 3. Patients who have previously undergone menopause due to physiological or pathological factors; 4. Patients with a history of gynaecological conditions (e.g., polycystic ovary syndrome, endometriosis) that may interfere with the assessment of menstrual recovery; 5. Patients currently participating in other clinical studies that may influence menstrual recovery; 6. Patients who refuse to participate in this clinical study.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

Китай · 5 центров
  • The First Affiliated Hospital of Zhengzhou University — Чжэнчжоу
  • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology — Ухань
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Ухань
  • The First People's Hospital of Yunnan Province — Куньмин
  • The First Affiliated Hospital, Zhejiang University School of Medicine — Ханчжоу

Идентификаторы

NCT: NCT07552493 · UHCT260112

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗