[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659333":3},{"organization":4,"outcomesModule":7,"designInfo":50,"detailedDescription":49,"studyPopulation":49,"armGroups":57,"interventions":75,"overallOfficials":49,"centralContacts":90,"locations":100,"responsibleParty":125,"collaborators":49,"id":127,"slug":128,"hasResults":129,"nctId":130,"briefTitle":131,"officialTitle":131,"acronym":49,"eligibilityCriteria":132,"healthyVolunteers":129,"sex":133,"minAge":134,"maxAge":135,"enrollmentInfo":136,"targetDuration":49,"studyType":139,"phases":140,"briefSummary":142,"conditions":143,"keywords":146,"overallStatus":152,"whyStopped":49,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":162},{"fullName":5,"class":6},"Hamad Medical Corporation","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":20,"otherOutcomes":49},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"Change in Sperm Concentration","Change in sperm concentration, measured in million sperm\u002FmL, from baseline to 6 months after initiation of treatment.","Baseline and 6 months",{"measure":14,"description":15,"timeFrame":12},"Change in Sperm Motility","Change in sperm motility, measured as the percentage of motile sperm, from baseline to 6 months after initiation of treatment.",{"measure":17,"description":18,"timeFrame":19},"Change in Sperm Morphology","Change in normal sperm morphology from baseline to 6 months after initiation of treatment.","from baseline to 6 months",[21,24,27,31,35,38,42,46],{"measure":22,"description":23,"timeFrame":12},"Change in oxidative stress \u002F oxidation-reduction potential","Change in seminal oxidative stress measured by oxidation-reduction potential (ORP).",{"measure":25,"description":26,"timeFrame":12},"Change in sperm DNA fragmentation","Change in sperm DNA fragmentation, measured using the study's specified sperm function testing method.",{"measure":28,"description":29,"timeFrame":30},"Change in follicle-stimulating hormone","Change in serum FSH concentration from baseline to 6 months.","Baseline to 6 months",{"measure":32,"description":33,"timeFrame":34},"Change in Luteinizing Hormone","Change in serum luteinizing hormone (LH) concentration from baseline to 6 months.","From baseline to 6 months.",{"measure":36,"description":37,"timeFrame":19},"Change in Testosterone","Change in serum testosterone concentration from baseline to 6 months.",{"measure":39,"description":40,"timeFrame":41},"Change in Estradiol","Change in serum estradiol concentration from baseline to 6 months.","baseline to 6 months",{"measure":43,"description":44,"timeFrame":45},"Treatment Tolerability and Adverse Events","Assessment of treatment tolerability and occurrence of adverse events during the treatment period.","From treatment initiation through 6 months",{"measure":47,"description":48,"timeFrame":45},"Medication Adherence","Assessment of adherence to the assigned study treatment during the treatment period.",null,{"allocation":51,"interventionModel":52,"interventionModelDescription":53,"primaryPurpose":54,"observationalModel":49,"timePerspective":49,"maskingInfo":55},"RANDOMIZED","PARALLEL","Three-arm, prospective, randomized, open-label, parallel-group controlled trial comparing antioxidant therapy alone with antioxidant therapy combined with clomiphene citrate or FSH","TREATMENT",{"masking":56,"maskingDescription":49,"whoMasked":49},"NONE",[58,65,71],{"label":59,"type":60,"description":61,"interventionNames":62},"Antioxidants Alone","ACTIVE_COMPARATOR","Participants will receive antioxidant therapy consisting of vitamin C 1000 mg\u002Fday, vitamin E 400 IU\u002Fday, L-carnitine, and zinc 25 mg\u002Fday for 6 months.",[63,64],"Drug: Antioxidants + Clomiphene Citrate","Drug: Antioxidants + FSH",{"label":66,"type":67,"description":68,"interventionNames":69},"Antioxidants + Clomiphene Citrate","EXPERIMENTAL","Participants will receive the same antioxidant regimen plus clomiphene citrate 50 mg orally every other day for 6 months.",[64,70],"Drug: Antioxidants Alone",{"label":72,"type":67,"description":73,"interventionNames":74},"Antioxidants + FSH","Participants will receive the same antioxidant regimen plus FSH 150 IU administered subcutaneously three times weekly for 6 months.",[63,70],[76,83,87],{"type":77,"name":66,"description":78,"armGroupLabels":79,"otherNames":80},"DRUG","Participants will receive the same antioxidant regimen as the active comparator arm plus clomiphene citrate 50 mg orally every other day for 6 months.",[72,59],[81,82],"Clomiphene Citrate","Antioxidants",{"type":77,"name":72,"description":73,"armGroupLabels":84,"otherNames":85},[66,59],[82,86],"follicle-stimulating hormone",{"type":77,"name":59,"description":88,"armGroupLabels":89,"otherNames":49},"Participants will receive antioxidant therapy consisting of vitamin C 1000 mg\u002Fday, vitamin E 400 IU\u002Fday, L-carnitine, and zinc 25 mg\u002Fday for 6 months",[66,72],[91,97],{"name":92,"role":93,"phone":94,"phoneExt":95,"email":96},"Dr. Haitham Tharwat El-Bardisi","CONTACT","66426664","00974","Helbardisi@hamad.qa",{"name":98,"role":93,"phone":49,"phoneExt":49,"email":99},"Dr. Nadir Ibrahim Fadol","NFadol1@hamad.qa",[101],{"facility":102,"status":49,"city":103,"state":104,"zip":105,"country":106,"countryCode":107,"cosmosGeoPoint":108,"geoPoint":113,"contacts":114},"Ambulatory Care Center (ACC), Hamad Medical Corporation","Doha","Baladiyat ad Dawhah","3050","Qatar","QA",{"type":109,"coordinates":110},"Point",[111,112],51.53096,25.28545,{"lat":112,"lon":111},[115,119,122],{"name":116,"role":93,"phone":117,"phoneExt":95,"email":118},"Sara Taha Shabana","55398571","sshabana@hamad.qa",{"name":120,"role":121,"phone":49,"phoneExt":49,"email":49},"Haitham El Bardisi","PRINCIPAL_INVESTIGATOR",{"name":123,"role":124,"phone":49,"phoneExt":49,"email":49},"Nadir Fadol","SUB_INVESTIGATOR",{"type":126,"investigatorFullName":49,"investigatorTitle":49,"investigatorAffiliation":49,"oldNameTitle":49,"oldOrganization":49},"SPONSOR","100659333","phase-4-comparative-efficacy-of-antioxidants-alone-versus-combined-therapy-with-serms-or-fsh-in-normogonadotropic-idiopathic-oat-patients-a-randomized-controlled-trial-100659333",false,"NCT07862725","Comparative Efficacy of Antioxidants Alone Versus Combined Therapy With SERMs or FSH in Normogonadotropic Idiopathic OAT Patients: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Male patients aged 21 to 50 years\n* Diagnosed with idiopathic oligoasthenoteratozoospermia\n* Sperm concentration ≥2 million\u002FmL on at least one semen analysis\n* FSH \\\u003C8.0 IU\u002FL\n* Normal serum testosterone\n* Normal karyotypeAbsence of Y-chromosome microdeletions\n* No varicocele or clinically insignificant Grade I varicocele only\n* Ability and willingness to comply with the study protocol and follow-up schedule\n* Provision of written informed consent.\n\nExclusion Criteria:\n\n* History of cryptorchidism.\n* Previous orchidopexy.\n* Previous testicular torsion.\n* Previous testicular trauma.\n* History of chemotherapy.\n* History of radiotherapy.\n* Previous testicular surgery.\n* Azoospermia.\n* Severe oligospermia with sperm concentration \\\u003C2 million\u002FmL.\n* Known genetic abnormalities, including Klinefelter syndrome.\n* Y-chromosome microdeletion.\n* Hormonal treatment for infertility within the previous 6 months.\n* Current use of medications known to affect spermatogenesis, including testosterone or anabolic steroids.\n* Significant medical comorbidities such as liver failure, renal disease, or uncontrolled diabetes. History of varicocelectomy within the previous year.\n* Pyospermia.","MALE","21 Years","50 Years",{"count":137,"type":138},360,"ESTIMATED","INTERVENTIONAL",[141],"PHASE4","This prospective randomized controlled trial will compare three treatment approaches for men with idiopathic oligoasthenoteratozoospermia (OAT), a condition characterized by abnormalities in sperm count, movement, and shape without an identified cause. Participants will be randomly assigned in a 1:1:1 ratio to receive antioxidant therapy alone, antioxidant therapy plus clomiphene citrate, or antioxidant therapy plus follicle-stimulating hormone (FSH) for 6 months.\n\nThe study will evaluate whether adding clomiphene citrate or FSH to antioxidant therapy improves semen parameters compared with antioxidant therapy alone. The main outcomes will include changes in sperm concentration, motility, and morphology. The study will also assess sperm function, hormonal changes, treatment adherence, and adverse events.",[144,145],"Oligoasthenoteratozoospermia","Male Infertility",[147,148,149,150,82,151],"Idiopathic infertility","Oligoasthenoteratozoospermi","Selective estrogen receptor modulators","FSH","Clomiphene citrate","NOT_YET_RECRUITING","2026-09-29",{"date":155,"type":156},"2026-10-07","ACTUAL",{"date":158,"type":138},"2026-10-15",{"date":160,"type":138},"2028-10-15",{"name":5,"class":6},1]