Serial Assessment of Fertility Experiences
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
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Sickle Cell Anemia. Базовые параметры: от 8 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
- Dominican Republic, Jamaica, Tanzania
- 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
A Prospective Longitudinal Study of Growth, Development, Fertility and Reproductive Outcomes Among Adolescents and Young Adults With Sickle Cell Anemia With Hydroxyurea
Обзор
The SAFE study is a long-term research project that watches people with sickle cell anemia (SCA) over time. The main goal is to see how a medicine called hydroxyurea affects their growth, puberty, and ability to have children. A second goal is to see how hydroxyurea affects pregnancy outcomes, by comparing people who take the medicine to those who don't.
Подробное описание
Hydroxyurea is a medicine that helps people with sickle cell anemia (SCA), a serious blood disease. It works by increasing a special type of hemoglobin (called fetal hemoglobin) that helps prevent sickle cell problems.
This medicine is especially helpful in places where it's hard to get safe blood transfusions. Studies from around the world have shown that hydroxyurea is safe and can reduce serious health problems caused by SCA (like pain, strokes, and lung issues). It can also help people with SCA live longer, healthier lives.
However, the investigators still don't know everything about how hydroxyurea affects long-term growth, puberty, fertility, or pregnancy; especially in areas with fewer medical resources.
To learn more, researchers are planning a large international study. They will follow people with SCA over time to see how hydroxyurea affects their development, ability to have children, and pregnancy outcomes. Participants will visit the clinic every few months for check-ups, blood tests, and other health assessments. Girls who have started their periods will take pregnancy tests every six months, and boys may be asked to provide a semen sample if they agree. Everyone will also answer questions about their health and fertility regularly.
Первичные конечные точки
- Clinical Outcomes [Срок оценки: From enrollment up to 10 years after enrollment.]
Вторичные конечные точки (12)
- Female Reproductive Potential and Outcomes [Срок оценки: From enrollment up to 10 years after enrollment.]
- Female Reproductive Potential and Outcomes [Срок оценки: From enrollment up to 10 years after enrollment.]
- Female Reproductive Potential and Outcomes [Срок оценки: From enrollment up to 10 years after enrollment.]
- Female Reproductive Potential and Outcomes [Срок оценки: From enrollment up to 10 years after enrollment.]
- Female Reproductive Potential and Outcomes [Срок оценки: From enrollment up to 10 years after enrollment.]
- Female Reproductive Potential and Outcomes [Срок оценки: From enrollment up to 10 years after enrollment.]
- Male Reproductive Potential and Outcomes [Срок оценки: From enrollment up to 10 years after enrollment.]
- Male Reproductive Potential and Outcomes [Срок оценки: From enrollment up to 10 years after enrollment.]
- Male Reproductive Potential and Outcomes [Срок оценки: From enrollment up to 10 years after enrollment.]
- Male Reproductive Potential and Outcomes [Срок оценки: From enrollment up to 10 years after enrollment.]
- Male Reproductive Potential and Outcomes [Срок оценки: From enrollment up to 10 years after enrollment.]
- Male Reproductive Potential and Outcomes [Срок оценки: From enrollment up to 10 years after enrollment.]
Критерии участия
Критерии включения
- Patients with documented sickle cell anemia (SCA).
- At least 8 years of age at the time of enrollment.
- Enrolled on the EXTEND or SACRED study.
- Provide informed consent.
- Able to take part in all parts of the study, including treatments, check-ups, and follow-up visits.
Критерии исключения
- Currently taking part in another treatment study (not EXTEND or SACRED).
- Has received other treatments for sickle cell disease in the past 6 months.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Dominican Republic · 1 центр
- Centro de Obstetricia y Ginecologia — Santo Domingo
Jamaica · 1 центр
- Caribbean Institute for Health Research, University of West Indies — Kingston
Tanzania · 1 центр
- Buganda Medical Centre — Mwanza
Идентификаторы
NCT: NCT07116772 · SAFE