Serial Assessment of Fertility Experiences
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 t
| Condition(s) | Sickle Cell Anemia |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| 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. |
| Who can participate | 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. |
| Ages | 8 Years |
| Sex | All |
| Lead sponsor | Children's Hospital Medical Center, Cincinnati |
| Locations | Santo Domingo, Dominican Republic; Kingston, Jamaica; Mwanza, Tanzania |
| Start date | 2023-07-10 |
| NCT ID | NCT07116772 |
| Official listing | https://clinicaltrials.gov/study/NCT07116772 |