Ovarian reserve during puberty in girls with sickle cell disease
Functional Ovarian Reserve in Sickle Cell Disease
This project will test whether AMH blood levels, a marker of ovarian reserve, differ during puberty in girls aged 10 to <19 with sickle cell disease compared with healthy girls.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 440 (estimated) |
| Ages | 10 Years to 18 Years |
| Sex | Female |
| Sponsor | St. Jude Children's Research Hospital Academic / other |
| Locations | 1 site (Memphis, Tennessee) |
| Trial ID | NCT07392216 on ClinicalTrials.gov |
What this trial studies
This is an observational cross-sectional two-year pilot embedded in a larger eight-year longitudinal effort that follows pre-teens and adolescents with sickle cell disease (SCD). Investigators will collect annual blood samples for AMH and other laboratory markers at routine clinic visits for participants with SCD and a one-time blood draw for healthy controls, plus annual questionnaires about puberty, menstrual history, contraception, and medications. Researchers will also review electronic medical records and the SCCRIP database to capture treatment exposures, vaso-occlusive events, ED/hospital visits, and laboratory history. The goal is to compare AMH trajectories and prevalence of markers of diminished ovarian function or premature ovarian insufficiency between SCD participants and matched controls.
Who should consider this trial
Good fit: Girls aged 10 through <19 with any genotype of sickle cell disease, or healthy female controls who are siblings, relatives, household members, or otherwise of similar race/ethnicity, are appropriate candidates.
Not a fit: Girls who have had or are preparing for hematopoietic stem cell transplant or gene therapy, those who are pregnant, or those unable to provide consent/assent are excluded and would not participate or directly benefit from this protocol.
Why it matters
Potential benefit: If successful, the project could identify early reductions or altered trajectories in ovarian reserve in girls with SCD, informing fertility counseling and timing of fertility-preserving interventions.
How similar studies have performed: Adult studies have reported lower AMH in some women with SCD, but longitudinal and puberty-focused data in pre-teens and adolescents are limited, making this approach relatively novel in younger patients.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Memphis, Tennessee
- St. Jude Children's Research Hospital — Memphis, Tennessee, United States (Recruiting)
Study contacts
- Principal investigator: Christine Yu, MD — St. Jude Children's Research Hospital
- Study coordinator: Christine Yu, MD
- Email: referralinfo@stjude.org
- Phone: 866-278-5833
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.