NCT07116772Recruiting
Serial Assessment of Fertility Experiences
A Prospective Longitudinal Study of Growth, Development, Fertility and Reproductive Outcomes Among Adolescents and Young Adults With Sickle Cell Anemia With Hydroxyurea
Source: ClinicalTrials.gov · Last updated 4 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 250 (estimated)
- First submitted
- 23 Jul 2025
- Start date
- 10 Jul 2023
- Primary completion date
- 19 May 2035
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Diseases
- Sickle cell disease
- NCT number
- NCT07116772
What you commit to
- Study type: Observational
- Planned participants: 250
- From 10 Jul 2023 to the primary completion date, 19 May 2035
- 3 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently taking part in another treatment study (not EXTEND or SACRED).
- Has received other treatments for sickle cell disease in the past 6 months.
Who the study is looking for
- 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.
Age in the registry: 8 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centro de Obstetricia y Ginecologia Coordinator of this site? Confirm its status | Santo Domingo | Dominican Republic | Recruiting |
| Caribbean Institute for Health Research, University of West Indies Coordinator of this site? Confirm its status | Kingston | Jamaica | Recruiting |
| Buganda Medical Centre Coordinator of this site? Confirm its status | Mwanza | Tanzania | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.