Ovarian reserve during puberty in girls with sickle cell disease
Official title: Functional Ovarian Reserve in Sickle Cell Disease
Run by St. Jude Children's Research Hospital · NCT07392216 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 10 Years to 18 Years |
| Sex | Women only |
| Enrollment | 440 (estimated) |
| Sponsor | St. Jude Children's Research Hospital Academic / other |
| Locations | 1 site (Memphis, Tennessee) |
| Status | Recruiting |
| Started | June 2, 2026 |
| Main results expected | July 2028 |
| Study ends | February 2034 |
| Registry record updated | June 4, 2026 |
| Trial ID | NCT07392216 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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: 888-226-4343
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Cerebrovascular Reactivity Testing with HD-DOT in Sickle Cell Patients
This study tests whether high-density diffuse optical tomography can measure brain blood flow and oxygen use in people with sickle cell disease, to see how these signals relate to stroke risk.
-
Adapting and testing PEN-Plus in Zambian primary care
Aiming to see if the PEN-Plus package can be adapted and used in two Zambian hospitals to better manage chronic diseases like heart disease, diabetes, hypertension, and sickle cell in primary care.
-
Newborn Sickle Cell Screening in Mozambique
We’re testing a three-part plan to help babies in Mozambique get diagnosed early for sickle cell disease and start care quickly.
-
Optimizing Hydroxyurea in Children with Sickle Cell in Africa
This study tests whether raising hydroxyurea to a maximum tolerated dose is safe and beneficial for Ugandan children with sickle cell anemia already taking a fixed daily dose.
-
Hematopoietic stem cell editing to treat sickle cell disease
This study tests whether a patient’s own blood stem cells can be edited to remove the sickle cell triggering gene and then returned to the patient.
-
Virtual reality options to help with VOC pain in adults with SCD
This study tests whether headset-based virtual reality can help reduce pain for adults with sickle cell disease during vaso-occlusive crises treated in an infusion center.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.