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Taking people in JamaicaNo phase

Hydroxyurea's effects on growth and fertility in young people with sickle cell anemia

Follows young people with sickle cell anemia taking hydroxyurea over time.

Key facts

Who runs it
Children's Hospital Medical Center, Cincinnati
Where
Kingston, JamaicaSee the siteAlso in 2 other countries, 2 sites
Trial code
Registry title
Serial Assessment of Fertility Experiences
Status
Recruiting
People taking part
250 people, planned
Started
10 Jul 2023
Expected to end
31 Dec 2035
Type of study
Observational
Record updated
4 February 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for people with sickle cell anemia who are enrolled on the EXTEND or SACRED study. It follows their growth, puberty, fertility and pregnancy outcomes with hydroxyurea.

Age
At least 8 years old.
Sex
All sexes can join.
Disease stage
Documented sickle cell anemia (SCA).
Earlier treatment
Cannot have had other treatments for sickle cell disease in the past 6 months.

Main reasons for not taking part

  • Currently taking part in another treatment study (other than EXTEND or SACRED)
  • Other treatments for sickle cell disease in the past 6 months
  • Unable to take part in all parts of the study

The registry criteria, word for word

Show all 7 criteriaShow less

Who can take part

  • 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

Who cannot take part

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

Where in Jamaica

Also in 2 other countries, 2 sites

  • Caribbean Institute for Health Research, University of West IndiesKingston, JamaicaContact: Teresa Latham, PhDTaking people

About the trial

What the trial wants to find out

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.

The group in the trial

  • Sickle Cell Anemia

    Those with sickle cell anemia (SCA).

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Prospective Longitudinal Study of Growth, Development, Fertility and Reproductive Outcomes Among Adolescents and Young Adults With Sickle Cell Anemia With Hydroxyurea
Plain-language title
Hydroxyurea's effects on growth and fertility in young people with sickle cell anemiaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
4 February 2026