Functional Ovarian Reserve in Sickle Cell Disease

Part of paid clinical trials in Memphis, Tennessee.

Sponsor
St. Jude Children's Research Hospital
Study ID
NCT07392216
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
10 Years - 18 Years
Healthy Volunteers
Accepted

Study Details

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.

Key Dates

Start date
Jun 2, 2026
Status verified
Jun 2026
Primary completion
Jul 31, 2028
Completion
Feb 28, 2034

Study Design

Enrollment
440 participants (estimated)

Arms

  • Arm: Participants with Sickle Cell Disease
    Females with sickle cell disease, all genotypes (age at enrollment ≥ 10 years and \< 19 years)
  • Arm: Healthy Controls
    Healthy female siblings/relatives of patients with SCD (including those with sickle cell trait), and other females of similar race/ethnicity (age at enrollment ≥ 10 years and \< 19 years)

Primary Outcome Measure

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 age [ Time Frame: Earliest AMH collection after enrollment, up to 2 years after study activation ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
St. Jude Children's Research HospitalMemphisTennessee38105
Christine Yu, MD
[email protected]
888-226-4343
Christine Yu, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Memphis, TN

By condition
Sickle cell disease
By research site
St. Jude Children's Research Hospital· Memphis, TN

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