Recruiting

AMH LevelsFunctional Ovarian Reserve in Sickle Cell Disease

Sponsor:

St. Jude Children's Research Hospital

Code:

NCT07392216

Conditions

Sickle Cell Disease

Eligibility Criteria

Sex: Female

Age: 10 - 18

Healthy Volunteers: Accepted

Study Details

Brief 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.

Conditions

Sickle Cell Disease

Study ID

NCT07392216

Start date

Jun 2, 2026

Status verified date

Jun, 2026

Completion date

Feb, 2034

Anticipated

Primary completion date

Jul, 2028

Anticipated

Eligibility Criteria

Sex: Female

Age: 10 - 18

Healthy Volunteers: Accepted

Inclusion Criteria:

Sickle cell disease of any genotype or a healthy sibling, relative, household member, or other females of similar race/ethnicity of a patient with sickle cell disease
Age at enrollment ≥ 10 years and < 19 years
Females

Exclusion Criteria:

History of hematopoietic stem cell transplantation or gene therapy prior to enrollment or preparing for hematopoietic stem cell transplantation or gene therapy prior to enrollment
Inability or unwillingness of research participant or legal guardian/representative to give written informed consent
Pregnancy

Study Design

Enrollment

440 participants

Anticipated

Interventions and Outcome Measures

Arms

Participants with Sickle Cell Disease

Females with sickle cell disease, all genotypes (age at enrollment ≥ 10 years and < 19 years)

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

Central Contacts and Locations

Central contacts

Christine Yu, MD

888-226-4343 referralinfo@stjude.org

Locations

St. Jude Children's Research Hospital

Recruiting

Memphis, Tennessee, United States, 38105

Contacts

Christine Yu, MD

888-226-4343 referralinfo@stjude.org

Principal Investigator:

Christine Yu, MD

More Information

Sponsor

St. Jude Children's Research Hospital

Last update posted

Jun 4, 2026

Last verified

Jun, 2026

Keywords

Ovary Function
Sickle Cell Disease
Children
Female
Puberty
Anti-Mullerian Hormone (AMH)
Healthy Controls

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St. Jude Children's Research Hospital on 2026-06-04.