NCT07116772 Serial Assessment of Fertility Experiences
| NCT ID | NCT07116772 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Children's Hospital Medical Center, Cincinnati |
| Condition | Sickle Cell Anemia |
| Study Type | OBSERVATIONAL |
| Enrollment | 250 participants |
| Start Date | 2023-07-10 |
| Primary Completion | 2035-05-19 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 250 participants in total. It began in 2023-07-10 with a primary completion date of 2035-05-19.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Russell E Ware, MD, PhD
PRINCIPAL INVESTIGATOR
Children's Hospital Medical Center, Cincinnati
Frequently Asked Questions
Who can join the NCT07116772 clinical trial?
This trial is open to participants of all sexes, aged 8 Years or older, studying Sickle Cell Anemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07116772 currently recruiting?
Yes, NCT07116772 is actively recruiting participants. Contact the research team at Teresa.Latham@cchmc.org for enrollment information.
Where is the NCT07116772 trial being conducted?
This trial is being conducted at Santo Domingo, Dominican Republic, Kingston, Jamaica, Mwanza, Tanzania.
Who is sponsoring the NCT07116772 clinical trial?
NCT07116772 is sponsored by Children's Hospital Medical Center, Cincinnati. The principal investigator is Russell E Ware, MD, PhD at Children's Hospital Medical Center, Cincinnati. The trial plans to enroll 250 participants.
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