[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100601920":3},{"organization":4,"outcomesModule":7,"designInfo":37,"detailedDescription":40,"studyPopulation":41,"armGroups":42,"interventions":36,"overallOfficials":46,"centralContacts":50,"locations":59,"responsibleParty":108,"collaborators":110,"id":116,"slug":117,"hasResults":118,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":122,"eligibilityCriteria":123,"healthyVolunteers":118,"sex":124,"minAge":125,"maxAge":36,"enrollmentInfo":126,"targetDuration":36,"studyType":129,"phases":36,"briefSummary":130,"conditions":131,"keywords":132,"overallStatus":62,"whyStopped":36,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":145},{"fullName":5,"class":6},"Children's Hospital Medical Center, Cincinnati","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":36},[9],{"measure":10,"description":11,"timeFrame":12},"Clinical Outcomes","The number of people who experience serious health events like pregnancy, stroke, cancer, or death.","From enrollment up to 10 years after enrollment.",[14,17,19,21,23,25,27,30,32,33,34,35],{"measure":15,"description":16,"timeFrame":12},"Female Reproductive Potential and Outcomes","Female fertility potential will be measured using serum anti-mullerian hormone (physiologic parameter)",{"measure":15,"description":18,"timeFrame":12},"Female ability to conceive will be assessed using incidence of pregnancy (questionnaire)",{"measure":15,"description":20,"timeFrame":12},"Outcomes of pregnancy will be categorized as either abortion or live birth (questionnaire)",{"measure":15,"description":22,"timeFrame":12},"Mode of delivery will be categorized as vaginal or c-section (questionnaire)",{"measure":15,"description":24,"timeFrame":12},"Prematurity of infant will be categorized as premature or full term (questionnaire)",{"measure":15,"description":26,"timeFrame":12},"Weight of infant will be categorized as normal birth weight or low birth weight (questionnaire)",{"measure":28,"description":29,"timeFrame":12},"Male Reproductive Potential and Outcomes","Male fertility potential will be measured using sperm analysis (physiologic parameter)",{"measure":28,"description":31,"timeFrame":12},"Male ability to conceive will be assessed using incidence of impregnated partner (questionnaire)",{"measure":28,"description":20,"timeFrame":12},{"measure":28,"description":22,"timeFrame":12},{"measure":28,"description":24,"timeFrame":12},{"measure":28,"description":26,"timeFrame":12},null,{"allocation":36,"interventionModel":36,"interventionModelDescription":36,"primaryPurpose":36,"observationalModel":38,"timePerspective":39,"maskingInfo":36},"COHORT","PROSPECTIVE","Hydroxyurea is a medicine that helps people with sickle cell anemia (SCA), a serious blood disease. It works by increasing a special type of hemoglobin (called fetal hemoglobin) that helps prevent sickle cell problems.\n\nThis medicine is especially helpful in places where it's hard to get safe blood transfusions. Studies from around the world have shown that hydroxyurea is safe and can reduce serious health problems caused by SCA (like pain, strokes, and lung issues). It can also help people with SCA live longer, healthier lives.\n\nHowever, the investigators still don't know everything about how hydroxyurea affects long-term growth, puberty, fertility, or pregnancy; especially in areas with fewer medical resources.\n\nTo learn more, researchers are planning a large international study. They will follow people with SCA over time to see how hydroxyurea affects their development, ability to have children, and pregnancy outcomes. Participants will visit the clinic every few months for check-ups, blood tests, and other health assessments. Girls who have started their periods will take pregnancy tests every six months, and boys may be asked to provide a semen sample if they agree. Everyone will also answer questions about their health and fertility regularly.","People with sickle cell anemia who are at least 8 years old and seen in Jamaica and Dominican Republic.",[43],{"label":44,"type":36,"description":45,"interventionNames":36},"Sickle Cell Anemia","Those with sickle cell anemia (SCA).",[47],{"name":48,"affiliation":5,"role":49},"Russell E Ware, MD, PhD","PRINCIPAL_INVESTIGATOR",[51,56],{"name":52,"role":53,"phone":54,"phoneExt":36,"email":55},"Teresa Latham, DrPh","CONTACT","513-803-7822","Teresa.Latham@cchmc.org",{"name":48,"role":53,"phone":57,"phoneExt":36,"email":58},"513-803-4597","Russell.Ware@cchmc.org",[60,78,92],{"facility":61,"status":62,"city":63,"state":36,"zip":36,"country":64,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":71,"contacts":72},"Centro de Obstetricia y Ginecologia","RECRUITING","Santo Domingo","Dominican Republic","DO",{"type":67,"coordinates":68},"Point",[69,70],-69.89232,18.47186,{"lat":70,"lon":69},[73,76],{"name":74,"role":53,"phone":75,"phoneExt":36,"email":55},"Teresa Latham, PhD","513-803-7922",{"name":77,"role":49,"phone":36,"phoneExt":36,"email":36},"Rafael Mena, PhD",{"facility":79,"status":62,"city":80,"state":36,"zip":36,"country":81,"countryCode":82,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"Caribbean Institute for Health Research, University of West Indies","Kingston","Jamaica","JM",{"type":67,"coordinates":84},[85,86],-76.79358,17.99702,{"lat":86,"lon":85},[89,90],{"name":74,"role":53,"phone":75,"phoneExt":36,"email":55},{"name":91,"role":49,"phone":36,"phoneExt":36,"email":36},"Marvin Reid, MB, BS, PhD",{"facility":93,"status":62,"city":94,"state":36,"zip":36,"country":95,"countryCode":36,"cosmosGeoPoint":96,"geoPoint":100,"contacts":101},"Buganda Medical Centre","Mwanza","Tanzania",{"type":67,"coordinates":97},[98,99],32.9,-2.51667,{"lat":99,"lon":98},[102,105],{"name":103,"role":53,"phone":36,"phoneExt":36,"email":104},"Emmanuela Ambrose MD","emmanuelaambrose@gmail.com",{"name":74,"role":53,"phone":106,"phoneExt":36,"email":107},"1-513-803-7922","teresa.latham@cchmc.org",{"type":109,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR",[111,113],{"name":112,"class":6},"The University of The West Indies",{"name":114,"class":115},"Centro de Obstetricia y Ginecologia Recruiting Santo Domingo, Dominican Republic","UNKNOWN","100601920","serial-assessment-of-fertility-experiences-100601920",false,"NCT07116772","Serial Assessment of Fertility Experiences","A Prospective Longitudinal Study of Growth, Development, Fertility and Reproductive Outcomes Among Adolescents and Young Adults With Sickle Cell Anemia With Hydroxyurea","SAFE","Inclusion Criteria:\n\n* Patients with documented sickle cell anemia (SCA).\n* At least 8 years of age at the time of enrollment.\n* Enrolled on the EXTEND or SACRED study.\n* Provide informed consent.\n* Able to take part in all parts of the study, including treatments, check-ups, and follow-up visits.\n\nExclusion Criteria:\n\n* Currently taking part in another treatment study (not EXTEND or SACRED).\n* Has received other treatments for sickle cell disease in the past 6 months.","ALL","8 Years",{"count":127,"type":128},250,"ESTIMATED","OBSERVATIONAL","The SAFE study is a long-term research project that watches people with sickle cell anemia (SCA) over time. The main goal is to see how a medicine called hydroxyurea affects their growth, puberty, and ability to have children. A second goal is to see how hydroxyurea affects pregnancy outcomes, by comparing people who take the medicine to those who don't.",[44],[133,134,135],"Hydroxyurea","Fertility","Sickle Cell Disease","2026-02-03",{"date":138,"type":139},"2026-02-04","ACTUAL",{"date":141,"type":139},"2023-07-10",{"date":143,"type":128},"2035-12-31",{"name":5,"class":6},3]