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