NCT07116772 Serial Assessment of Fertility Experiences
| NCT ID | NCT07116772 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Children's Hospital Medical Center, Cincinnati |
| Condition | Sickle Cell Anemia |
| Study Type | OBSERVATIONAL |
| Enrollment | 250 participants |
| Start Date | 2023-07-10 |
| Primary Completion | 2035-05-19 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
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.
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.
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