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NCT07392216 · ClinicalTrials.gov registry record
Functional Ovarian Reserve in Sickle Cell Disease
A clinical trial, sponsored by St. Jude Children's Research Hospital.
- Recruiting
- Registry status
- 440
- Enrollment target
NCT07392216: Recruiting study, sponsored by St. Jude Children's Research Hospital.
NCT07392216 is a clinical trial that is actively recruiting participants, run by St. Jude Children's Research Hospital. The registered enrollment target is 440 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07392216 is actively recruiting participants, sponsored by St. Jude Children's Research Hospital.
- RECRUITING
- Registry status
- 440 participants
- Enrollment target
Study Summary
This study aims to look at AMH levels in female children with SCD as they go through puberty to see if they are at the same level as other children without SCD at the same age and/or pubertal stage and will also look at how treatment exposures and pain crises affect the AMH levels in children with SCD. Primary Objective: * To evaluate whether AMH levels are lower in pre-teens and adolescent females with SCD when compared with healthy female controls (siblings, relatives, non-relatives of similar race/ethnicity) at the same age and pubertal stage. Secondary Objectives: * To evaluate whether AMH has a similar trajectory in female pre-teens and adolescents with SCD when compared with the general population and controls. * To describe pubertal timing, menstrual history, and markers of functional ovarian reserve (FOR), as well as prevalence of premature ovarian insufficiency (POI) as determined by medical history and laboratory markers in pre-teens and adolescents with SCD in comparison with their female controls. * To correlate AMH levels with FSH and estradiol levels, normal pubertal timing, and menstrual history in children and adolescents with SCD. * To correlate the severity of SCD (number of vaso-occlusive events) with pubertal timing, presence of normal vs abnormal menstruation, and laboratory markers of FOR, in pre-teens and adolescents with SCD. * To correlate the use of SCD modifying treatment modalities with pubertal timing, menstrual pattern, and laboratory markers of FOR in pre-teens and adolescents with SCD.
Primary Outcome
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) re
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 440 participants |
| Start Date | 2026-06-02 |
| Est. Completion | 2034-02 |
What NCT07392216 shows while recruiting
NCT07392216 is an observational study that tracks outcomes without assigning an intervention. The registered 440 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT07392216 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07392216 about?
NCT07392216 is a clinical study titled "Functional Ovarian Reserve in Sickle Cell Disease". This study aims to look at AMH levels in female children with SCD as they go through puberty to see if they are at the same level as other children without SCD at the same age and/or pubertal stage and will also look at how treatment exposures and pain crises affect the AMH levels in children with S...
What is the current status of trial NCT07392216?
This trial is currently recruiting. The enrollment target is 440 participants. The study started on 2026-06-02. Estimated completion is 2034-02.
Who is sponsoring clinical trial NCT07392216?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
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