[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100531034":3},{"organization":4,"armGroups":7,"interventions":7,"overallOfficials":8,"centralContacts":13,"locations":18,"responsibleParty":36,"collaborators":7,"id":38,"slug":39,"hasResults":40,"nctId":41,"briefTitle":42,"officialTitle":43,"acronym":7,"eligibilityCriteria":44,"healthyVolunteers":40,"sex":45,"minAge":46,"maxAge":47,"enrollmentInfo":48,"targetDuration":7,"studyType":51,"phases":7,"briefSummary":52,"conditions":53,"keywords":55,"overallStatus":21,"whyStopped":7,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":67},{"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,"countryCode":26,"cosmosGeoPoint":27,"geoPoint":32,"contacts":33},"Natan Bar-Chama MD","RECRUITING","Cresskill","New Jersey","07626","United States","US",{"type":28,"coordinates":29},"Point",[30,31],-73.9593,40.94149,{"lat":31,"lon":30},[34],{"name":10,"role":15,"phone":35,"phoneExt":7,"email":17},"201-694-1781",{"type":37,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100531034","assessing-the-fertility-status-of-men-with-spinal-muscular-atrophy-sma-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":49,"type":50},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.",[54],"Fertility Issues",[56,57],"Men","Spinal Muscular Atrophy","2024-01-04",{"date":60,"type":61},"2024-01-08","ACTUAL",{"date":63,"type":50},"2024-02",{"date":65,"type":50},"2026-07",{"name":5,"class":6},1]