[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100531034":3},{"organization":4,"armGroups":7,"interventions":7,"overallOfficials":8,"centralContacts":13,"locations":18,"responsibleParty":35,"collaborators":7,"id":37,"slug":7,"hasResults":38,"nctId":39,"briefTitle":40,"officialTitle":41,"acronym":7,"eligibilityCriteria":42,"healthyVolunteers":38,"sex":43,"minAge":44,"maxAge":45,"enrollmentInfo":46,"targetDuration":7,"studyType":49,"phases":7,"briefSummary":50,"conditions":51,"keywords":53,"overallStatus":21,"whyStopped":7,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":65},{"fullName":5,"class":6},"Bar-Chama, Natan, M.D.","OTHER",null,[9],{"name":10,"affiliation":11,"role":12},"Natan Bar-Chama, MD","The Mount Sinai Hospital","PRINCIPAL_INVESTIGATOR",[14],{"name":10,"role":15,"phone":16,"phoneExt":7,"email":17},"CONTACT","2016941781","support@malefertilitysma.com",[19],{"facility":20,"status":21,"city":22,"state":23,"zip":24,"country":25,"cosmosGeoPoint":26,"geoPoint":31,"contacts":32},"Natan Bar-Chama MD","RECRUITING","Cresskill","New Jersey","07626","United States",{"type":27,"coordinates":28},"Point",[29,30],-73.9593,40.94149,{"lat":30,"lon":29},[33],{"name":10,"role":15,"phone":34,"phoneExt":7,"email":17},"201-694-1781",{"type":36,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100531034",false,"NCT06194539","Assessing the Fertility Status of Men With Spinal Muscular Atrophy (SMA)","The Assessment of Fertility in Men With Spinal Muscular Atrophy (SMA)","Inclusion Criteria:\n\n* Signed Informed Consent Form (or assent)\n* Male and age greater than 18 years and less than 50 years of age with a confirmed diagnosis of SMA at the time of signing the Informed Consent Form (or assent)\n* Currently not on a disease-modifying agent or therapy for SMA\n* Adequately recovered from any acute illness at the time of screening, and considered clinically well enough to participate in the study.\n\nExclusion Criteria:\n\nMen with a prior history of chemotherapy, radiation therapy, prostate or testicular cancer, undescended testicles and use of anabolic steroids or testosterone usage will be excluded","MALE","18 Years","50 Years",{"count":47,"type":48},75,"ESTIMATED","OBSERVATIONAL","This study will aim to assess the fertility status of men with Spinal Muscular Atrophy (SMA) not on disease-modifying therapies.\n\nParticipants will:\n\n1. Complete online questionnaires that will assess SMA diagnosis and disease burden, medical and surgical history, medication usage, and fertility status and perspectives.\n2. Over the 3-month initial study baseline period participants will provide two separate ejaculates for semen analysis and a single determination of sperm quality using DNA fragmentation testing using home collection and subsequent shipment to a central laboratory.\n3. Over the initial study baseline period of 3 months study participants will obtain a blood test to determine male reproductive hormone levels.\n\nDuring the 24-month study duration, participants will be requested to undergo a yearly semen analysis and complete online relevant questionnaires.",[52],"Fertility Issues",[54,55],"Men","Spinal Muscular Atrophy","2024-01-04",{"date":58,"type":59},"2024-01-08","ACTUAL",{"date":61,"type":48},"2024-02",{"date":63,"type":48},"2026-07",{"name":5,"class":6},1]