Serial Assessment of Fertility Experiences

Recruiting

• Conditions: Sickle Cell Anemia

• Registration Number: NCT07116772
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

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.

Detailed Description

Hydroxyurea is a medicine that helps people with sickle cell anemia (SCA), a serious blood disease. It works by increasing a special type of hemoglobin (called fetal hemoglobin) that helps prevent sickle cell problems.

This medicine is especially helpful in places where it's hard to get safe blood transfusions. Studies from around the world have shown that hydroxyurea is safe and can reduce serious health problems caused by SCA (like pain, strokes, and lung issues). It can also help people with SCA live longer, healthier lives.

However, the investigators still don't know everything about how hydroxyurea affects long-term growth, puberty, fertility, or pregnancy; especially in areas with fewer medical resources.

To learn more, researchers are planning a large international study. They will follow people with SCA over time to see how hydroxyurea affects their development, ability to have children, and pregnancy outcomes. Participants will visit the clinic every few months for check-ups, blood tests, and other health assessments. Girls who have started their periods will take pregnancy tests every six months, and boys may be asked to provide a semen sample if they agree. Everyone will also answer questions about their health and fertility regularly.

Study Timeline

• Study Start: 2023-07-10
• Study First Submitted: 2025-07-23
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-08
• Study First Posted: 2025-08-12
• Last Update Submitted: 2025-08-14
• Last Update Posted: 2025-08-19
• Primary Completion: 2035-05-19
• Study Completion: 2035-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical Outcomes	From enrollment up to 10 years after enrollment.	The number of people who experience serious health events like pregnancy, stroke, cancer, or death.

Secondary Outcome Measures

Name	Time	Method
Female Reproductive Potential and Outcomes	From enrollment up to 10 years after enrollment.	Weight of infant will be categorized as normal birth weight or low birth weight (questionnaire)
Male Reproductive Potential and Outcomes	From enrollment up to 10 years after enrollment.	Weight of infant will be categorized as normal birth weight or low birth weight (questionnaire)

Trial Locations

Locations (2)

Centro de Obstetricia y Ginecologia; 🇩🇴 Santo Domingo, Dominican Republic

Caribbean Institute for Health Research, University of West Indies; 🇯🇲 Kingston, Jamaica