Reproductive and Mental Health of Patients With Aplastic Anemia
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: Sex hormone monitoring.
- Кому может быть актуально
- Состояния в реестре: Aplastic Anemia, Reproductive Health. Базовые параметры: 18 лет — 40 лет · Все.
- 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
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Официальное название
A Study on Reproductive and Psychological Health in Aplastic Anemia Patients
Обзор
Aplastic anemia (AA) is a hematological disease characterized by bone marrow failure, leading to varying degrees of anemia, leukopenia, and thrombocytopenia. With the advancement of immunosuppressive therapy and hematopoietic stem cell transplantation, the survival of AA patients has significantly improved. However, these treatment approaches may result in reproductive system impairment. Reproductive health has been a major concern among reproductive-age AA patients. In female patients, it often manifests as irregular menstruation, amenorrhea, and infertility; while in male patients, it may present as reduced sperm count and low sperm motility. The reproductive impairment observed in AA patients may be attributed to various factors, including the disease's underlying pathophysiology, side effects of used medications such as androgens and the toxicity conditioning agents during transplantation. Notably, immunosuppressive agents (such as cyclosporine and antithymocyte globulin) and chemotherapeutic drugs (such as cyclophosphamide) can suppress hematopoiesis and directly damage the gonads, thereby impairing reproductive function. Furthermore, long-term use of these medications may disrupt the endocrine system, affecting the secretion of sex hormones and overall reproductive capacity. Additionally, chronic anemia in AA patients can lead to compensatory physiological changes in other body systems, which may also indirectly affect reproductive health.
Вмешательства
- Другое Sex hormone monitoring
Sex hormone monitoring includes the concentrations of follicle-stimulating hormone (FSH), luteinizing hormone (LH), estradiol (E2), progesterone (P), prolactin (PRL), and testosterone (T).
Первичные конечные точки
- Proportion of patients with abnormal sex hormone levels [Срок оценки: Baseline, 6 months post-treatment, 12 months post-treatment]
Вторичные конечные точки (3)
- Stress levels [Срок оценки: Baseline]
- Depression symptoms [Срок оценки: Baseline]
- Social support [Срок оценки: Baseline]
Критерии участия
Критерии включения
- Diagnosis of AA
- Male or female, aged 18-40 years
- ECOG performance status ≤2
- Willing and able to comply with the requirements for this study and written informed consent
Критерии исключения
- Diagnosis of inherited bone marrow failure syndromes
- Combined with other hematological diseases
- Chemotherapy-induced bone marrow failure
- Pregnant or breastfeeding women
- Subjects with a history of mental illness or severe psychological disorders
- Subjects with a history of reproductive system cancer (eg, penile cancer, testicular cancer, prostate cancer, ovarian cancer, cervical cancer, vaginal cancer, etc.)
- Subjects that the investigator believes have other reasons that make them unsuitable for inclusion in this study
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Дизайн исследования
- Модель наблюдения
- Только случаи
Центры проведения
Китай · 1 центр
- Regenerative Medicine Center — Тяньцзинь
Идентификаторы
NCT: NCT06936930 · QTJC2025034