[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Bar-Chama, Natan, M.D.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":41},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":5},"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":20,"type":21},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.",[25],"Fertility Issues",[27,28],"Men","Spinal Muscular Atrophy","RECRUITING","2024-01-04",{"date":32,"type":33},"2024-01-08","ACTUAL",{"date":35,"type":21},"2024-02",{"date":37,"type":21},"2026-07",{"name":39,"class":40},"Bar-Chama, Natan, M.D.","OTHER",""]