[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07392216":3,"trial-entities:NCT07392216":87,"trial-summary:NCT07392216":90},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":29,"interventions":32,"primary_outcomes":33,"secondary_outcomes":41,"sex":42,"minimum_age":43,"maximum_age":44,"healthy_volunteers":45,"eligibility_criteria":46,"std_ages":56,"locations":59,"central_contacts":76,"overall_officials":78,"references":80,"see_also_links":81},"NCT07392216","FORSCD","Functional Ovarian Reserve in Sickle Cell Disease","RECRUITING","2034-02","2026-06","2026-06-04","2026-06-02","St. Jude Children's Research Hospital","OTHER",false,"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\u002For pubertal stage and will also look at how treatment exposures and pain crises affect the AMH levels in children with SCD.\n\nPrimary Objective:\n\n* 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\u002Fethnicity) at the same age and pubertal stage.\n\nSecondary Objectives:\n\n* To evaluate whether AMH has a similar trajectory in female pre-teens and adolescents with SCD when compared with the general population and controls.\n* 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.\n* To correlate AMH levels with FSH and estradiol levels, normal pubertal timing, and menstrual history in children and adolescents with SCD.\n* 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.\n* 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.","This is a non-therapeutic cross-sectional two-year pilot study within an eight-year longitudinal study.\n\nAfter the parent and\u002For patient has given permission to enroll on the research study, review of the electronic medical record and SCCRIP (NCT02098863) data base will be performed to obtain data on current medical therapy, number of vaso-occlusive events and types of events as well as ED or hospital visits, laboratory studies and use of sickle cell disease modifying therapies.\n\nA questionnaire will be distributed annually from time of enrollment until age 19.0 years to participants with SCD and consenting legal guardian (if applicable). For healthy controls, the same questionnaire will be provided to coincide with their one-time research visit. Pubertal status will be collected from questionnaires (prepubertal\u002Fno breast tissue, pubertal (breast tissue, but no menses), post-menarcheal. For those menstruating, regularity of menses will be ascertained through questionnaire answers and also date of last menstrual period. Questions for participants will also include questions regarding all forms of hormonal contraception and current opiate-containing medications.\n\nFor subjects with SCD, blood will be collected at the time of a clinic visit and occur concurrently with an already scheduled lab draw for clinical care with a goal frequency of annually. For controls, blood will be collected at a one-time study visit.",[18],"Sickle Cell Disease",[20,18,21,22,23,24,25],"Ovary Function","Children","Female","Puberty","Anti-Mullerian Hormone (AMH)","Healthy Controls","OBSERVATIONAL",null,[],{"count":30,"type":31},440,"ESTIMATED",[],[34,38],{"measure":35,"description":36,"timeFrame":37},"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","Investigators will address this by targeting the relative difference in mean. For each participant, the earliest AMH measurement will be used. All patients recruited during the cross-sectional stage with at least 1 AMH measurement will be evaluable for the analysis, except for patients who have received hematopoietic stem cell transplant (HSCT) or gene therapy before their first study AMH measurement. Patients who either (1) have no available AMH at the end of the cross-sectional phase or (2) received HSCT or gene therapy before their first study AMH measurement will be considered unevaluable for this analysis.","Earliest AMH collection after enrollment, up to 2 years after study activation",{"measure":39,"description":40,"timeFrame":37},"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","Investigators will address this by targeting the relative difference in mean. For each participant, the earliest AMH measurement will be used. Pubertal status will be defined as a nominal variable with the following categories: prepubertal, pubertal but premenarchal, postmenarchal, and 3 years postmenarchal. This will be derived from the self-reported status of any breast development and experiencing menarche by the time of the visit with the AMH draw.",[],"FEMALE","10 Years","18 Years",true,{"inclusion":47,"exclusion":51,"raw_text":55},[48,49,50],"Sickle cell disease of any genotype or a healthy sibling, relative, household member, or other females of similar race\u002Fethnicity of a patient with sickle cell disease","Age at enrollment ≥ 10 years and \\\u003C 19 years","Females",[52,53,54],"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\u002Frepresentative to give written informed consent","Pregnancy","Inclusion Criteria:\n\n* Sickle cell disease of any genotype or a healthy sibling, relative, household member, or other females of similar race\u002Fethnicity of a patient with sickle cell disease\n* Age at enrollment ≥ 10 years and \\\u003C 19 years\n* Females\n\nExclusion Criteria:\n\n* 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\n* Inability or unwillingness of research participant or legal guardian\u002Frepresentative to give written informed consent\n* Pregnancy",[57,58],"CHILD","ADULT",[60],{"facility":12,"status":7,"city":61,"state":62,"zip":63,"country":64,"contacts":65,"geoPoint":73},"Memphis","Tennessee","38105","United States",[66,71],{"name":67,"role":68,"phone":69,"email":70},"Christine Yu, MD","CONTACT","888-226-4343","referralinfo@stjude.org",{"name":67,"role":72},"PRINCIPAL_INVESTIGATOR",{"lat":74,"lon":75},35.14953,-90.04898,[77],{"name":67,"role":68,"phone":69,"email":70},[79],{"name":67,"affiliation":12,"role":72},[],[82,84],{"label":12,"url":83},"http:\u002F\u002Fwww.stjude.org",{"label":85,"url":86},"Clinical Trials Open at St. Jude","http:\u002F\u002Fwww.stjude.org\u002Fprotocols",{"nct_id":4,"conditions":88,"biomarkers":89},[25,18],[],{"nct_id":4,"found":45,"summary":91,"prompt_version":100},{"design":92,"status":93,"heading":6,"summary":94,"follow_up":95,"word_count":96,"commitments":97,"compensation":98,"drugs_mentioned":99},"This is a non-therapeutic, cross-sectional pilot study involving 440 female participants, aged 10 to 18 years, with or without sickle cell disease.","completed","This observational study is looking at how sickle cell disease (SCD) might affect the ovarian reserve (the number of eggs a woman has) in girls aged 10 to 18. Researchers will measure AMH levels (Anti-Müllerian Hormone, a marker for ovarian reserve) in girls with SCD and compare them to healthy girls of the same age and pubertal stage. The study also aims to understand if treatments for SCD or pain crises impact these AMH levels. The goal is to see if girls with SCD have lower AMH levels than their healthy peers, which could affect their future fertility.","AMH levels will be measured at the earliest collection after enrollment, up to 2 years after study activation. Questionnaires will be distributed annually until age 19.",98,"If you have SCD, you would have blood drawn annually during a regular clinic visit. You and your legal guardian (if applicable) would also complete an annual questionnaire until you turn 19. If you are a healthy control, you would have a one-time research visit and complete a questionnaire.","Not stated in the trial record.",[],"v2"]