RecruitingNCT07116772

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


Sponsor

Children's Hospital Medical Center, Cincinnati

Enrollment

250 participants

Start Date

Jul 10, 2023

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 8 Years

Inclusion Criteria5

  • 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 Criteria2

  • Currently taking part in another treatment study (not EXTEND or SACRED).
  • Has received other treatments for sickle cell disease in the past 6 months.

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Locations(3)

Centro de Obstetricia y Ginecologia

Santo Domingo, Dominican Republic

Caribbean Institute for Health Research, University of West Indies

Kingston, Jamaica

Buganda Medical Centre

Mwanza, Tanzania

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NCT07116772


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