Functional Ovarian Reserve in Sickle Cell Disease
This observational study is looking at how sickle cell disease (SCD) might affect the ovarian reserve (the number of eggs a woman has) in girls aged 10 to 18. Researchers will measure AMH levels (Anti-Müllerian Hormone, a marker for ovarian reserve) in girls with SCD and compare them to healthy girls of the same age and pubertal stage. The study also aims to understand if treatments for SCD or pain crises impact these AMH levels. The goal is to see if girls with SCD have lower AMH levels than their healthy peers, which could affect their future fertility.
- Study design
- This is a non-therapeutic, cross-sectional pilot study involving 440 female participants, aged 10 to 18 years, with or without sickle cell disease.
- What's involved
- If you have SCD, you would have blood drawn annually during a regular clinic visit. You and your legal guardian (if applicable) would also complete an annual questionnaire until you turn 19. If you are a healthy control, you would have a one-time research visit and complete a questionnaire.
- Compensation
- Not stated in the trial record.
- Follow-up
- AMH levels will be measured at the earliest collection after enrollment, up to 2 years after study activation. Questionnaires will be distributed annually until age 19.
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Functional Ovarian Reserve in Sickle Cell Disease
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Christine Yu, MD · PRINCIPAL_INVESTIGATOR · St. Jude Children's Research Hospital
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Difference in AMH levels in pre-teens and adolescent females with SCD compared with healthy female controls (siblings, relatives, or non-relatives) at the same ageEarliest AMH collection after enrollment, up to 2 years after study activation
Investigators will address this by targeting the relative difference in mean. For each participant, the earliest AMH measurement will be used. All patients recruited during the cross-sectional stage with at least 1 AMH measurement will be evaluable for the analysis, except for patients who have received hematopoietic stem cell transplant (HSCT) or gene therapy before their first study AMH measurement. Patients who either (1) have no available AMH at the end of the cross-sectional phase or (2) received HSCT or gene therapy before their first study AMH measurement will be considered unevaluable for this analysis.
- Difference in AMH levels in pre-teens and adolescent females with SCD compared with healthy female controls (siblings, relatives, or non-relatives) at the same pubertal stageEarliest AMH collection after enrollment, up to 2 years after study activation
Investigators will address this by targeting the relative difference in mean. For each participant, the earliest AMH measurement will be used. Pubertal status will be defined as a nominal variable with the following categories: prepubertal, pubertal but premenarchal, postmenarchal, and 3 years postmenarchal. This will be derived from the self-reported status of any breast development and experiencing menarche by the time of the visit with the AMH draw.