Serial Assessment of Fertility Experiences
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Sickle Cell Anemia. Basic parameters: from 8 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Dominican Republic, Jamaica, Tanzania
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Prospective Longitudinal Study of Growth, Development, Fertility and Reproductive Outcomes Among Adolescents and Young Adults With Sickle Cell Anemia With Hydroxyurea
Overview
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.
Detailed description
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.
Primary outcome measures
- Clinical Outcomes [Time frame: From enrollment up to 10 years after enrollment.]
Secondary outcome measures (12)
- Female Reproductive Potential and Outcomes [Time frame: From enrollment up to 10 years after enrollment.]
- Female Reproductive Potential and Outcomes [Time frame: From enrollment up to 10 years after enrollment.]
- Female Reproductive Potential and Outcomes [Time frame: From enrollment up to 10 years after enrollment.]
- Female Reproductive Potential and Outcomes [Time frame: From enrollment up to 10 years after enrollment.]
- Female Reproductive Potential and Outcomes [Time frame: From enrollment up to 10 years after enrollment.]
- Female Reproductive Potential and Outcomes [Time frame: From enrollment up to 10 years after enrollment.]
- Male Reproductive Potential and Outcomes [Time frame: From enrollment up to 10 years after enrollment.]
- Male Reproductive Potential and Outcomes [Time frame: From enrollment up to 10 years after enrollment.]
- Male Reproductive Potential and Outcomes [Time frame: From enrollment up to 10 years after enrollment.]
- Male Reproductive Potential and Outcomes [Time frame: From enrollment up to 10 years after enrollment.]
- Male Reproductive Potential and Outcomes [Time frame: From enrollment up to 10 years after enrollment.]
- Male Reproductive Potential and Outcomes [Time frame: From enrollment up to 10 years after enrollment.]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- Currently taking part in another treatment study (not EXTEND or SACRED).
- Has received other treatments for sickle cell disease in the past 6 months.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Dominican Republic · 1 center
- Centro de Obstetricia y Ginecologia — Santo Domingo
Jamaica · 1 center
- Caribbean Institute for Health Research, University of West Indies — Kingston
Tanzania · 1 center
- Buganda Medical Centre — Mwanza
Identifiers
NCT: NCT07116772 · SAFE