Clinical Trial

Serial Assessment of Fertility Experiences

Study acronym: SAFE
Recruiting
View on ClinicalTrials.gov →
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-08-08; most recent amendment 2026-02-03.
Trial Details
NCT Number NCT07116772
Lead Sponsor Children's Hospital Medical Center, Cincinnati
Collaborators: The University of The West Indies, Centro de Obstetricia y Ginecologia Recruiting Santo Domingo, Dominican Republic
Conditions Sickle Cell Anemia
Enrollment 250 participants
Start Date 2023-07-10
Primary Completion 2035-05-19 (estimated)
Study Completion 2035-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-02-04