Serial Assessment of Fertility Experiences
Recruiting · NCT07116772 · Observational (researchers observe without assigning treatment) · Lead sponsor: Children's Hospital Medical Center, Cincinnati
View the official record on ClinicalTrials.gov →What this trial is about
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 take part
Age range
8 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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.
Where it is running
3 locations listed.
- Caribbean Institute for Health Research, University of West Indies - Kingston, Jamaica
- Buganda Medical Centre - Mwanza, Tanzania
- Centro de Obstetricia y Ginecologia - Santo Domingo, Dominican Republic