Actively Recruiting

Age: 10Years - 18Years
FEMALE
Healthy Volunteers
NCT07392216

Functional Ovarian Reserve in Sickle Cell Disease

Led by St. Jude Children's Research Hospital · Updated on 2026-04-15

440

Participants Needed

1

Research Sites

404 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Functional Ovarian Reserve in Sickle Cell Disease

Who Can Participate

Age: 10Years - 18Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Female with sickle cell disease of any genotype or healthy female sibling, relative, or household member of similar race/ethnicity
  • Age 10 years or older and younger than 19 years at enrollment
Not Eligible

You will not qualify if you...

  • History of hematopoietic stem cell transplantation or gene therapy before enrollment, or preparing for such treatments
  • Unable or unwilling to provide written informed consent by participant or legal guardian
  • Current pregnancy

AI-Screening

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Trial Site Locations

Total: 1 location

1

St. Jude Children's Research Hospital

Memphis, Tennessee, United States, 38105

Actively Recruiting

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Research Team

C

Christine Yu, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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