Tracking growth, puberty, fertility, and pregnancy in people with sickle cell anemia
A Prospective Longitudinal Study of Growth, Development, Fertility and Reproductive Outcomes Among Adolescents and Young Adults With Sickle Cell Anemia With Hydroxyurea
This study will see if taking hydroxyurea changes growth, puberty, fertility, or pregnancy outcomes in people with sickle cell anemia.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 8 Years and up |
| Sex | All |
| Sponsor | Children's Hospital Medical Center, Cincinnati Academic / other |
| Locations | 3 sites (Santo Domingo and 2 other locations) |
| Trial ID | NCT07116772 on ClinicalTrials.gov |
What this trial studies
This is a long-term, international observational cohort that follows people with documented sickle cell anemia over time to record development and reproductive outcomes. Participants attend clinic visits every few months for clinical assessments and blood tests, with post-menarche girls having pregnancy tests every six months and boys optionally providing semen samples. The cohort will include people who are and are not taking hydroxyurea, allowing comparison of outcomes by medication exposure while collecting regular self-reported and clinical data. Enrollment generally requires being at least 8 years old and already enrolled in the EXTEND or SACRED studies, with informed consent obtained for ongoing follow-up.
Who should consider this trial
Good fit: Ideal candidates are people aged 8 years or older with documented sickle cell anemia who are enrolled in EXTEND or SACRED and willing to attend regular clinic visits and tests and provide informed consent.
Not a fit: People currently enrolled in other treatment trials or those who received other sickle cell treatments in the prior six months, and individuals not of reproductive potential or uninterested in fertility information, are unlikely to gain direct benefit from these fertility-focused outcomes.
Why it matters
Potential benefit: If successful, the study could clarify whether hydroxyurea has lasting effects on growth, sexual development, fertility, and pregnancy, helping clinicians and families make better treatment choices.
How similar studies have performed: Hydroxyurea is well-established to reduce many sickle cell complications and improve survival, but large international data on long-term growth, puberty, fertility, and pregnancy are limited, so this focused observational effort addresses a gap rather than repeating well-settled findings.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Santo Domingo and 2 other locations
- Centro de Obstetricia y Ginecologia — Santo Domingo, Dominican Republic (Recruiting)
- Caribbean Institute for Health Research, University of West Indies — Kingston, Jamaica (Recruiting)
- Buganda Medical Centre — Mwanza, Tanzania (Recruiting)
Study contacts
- Principal investigator: Russell E Ware, MD, PhD — Children's Hospital Medical Center, Cincinnati
- Study coordinator: Teresa Latham, DrPh
- Email: Teresa.Latham@cchmc.org
- Phone: 513-803-7822
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.