[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100436179":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":37,"locations":48,"responsibleParty":67,"collaborators":70,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":26,"eligibilityCriteria":79,"healthyVolunteers":80,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":26,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":93,"overallStatus":50,"whyStopped":26,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"GYNOV","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Isitol® (Food supplement treated group)","EXPERIMENTAL","36 eligible males between 20 and 45 yo. (included limits) will take 1 sachet of Isitol® per day during 16 (± 2) weeks. The sachet of powder is to dissolve in a glass of water or directly in mouth.\n\n1 sachet of Isitol® (2,1g) contains 1000 mg of myo-inositol, 300 mg of N-acetyl-cysteine, 150 % of the Nutritional Reference Values (NRV) in zinc and 100 % of the NRV: in vitamins B2, B3, B6, B9 and E.",[13],"Dietary Supplement: Isitol®",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo treated group","PLACEBO_COMPARATOR","36 eligible males between 20 and 45 yo. (included limits) will take 1 sachet of placebo per day during 16 (± 2) weeks. The sachet of powder is to dissolve in a glass of water or directly in mouth.\n\n1 sachet of placebo (2,1g) contains only excipients used in Isitol® and excipients to get similar organoleptic aspect (maltodextrin, sucralose, silicon dioxide, magnesium carbonate, citric acid and beta-carotene).",[19],"Other: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIETARY_SUPPLEMENT","Isitol®","1 sachet of Isitol® (2,1g) contains :\n\n* 1000 mg of myo-inositol ;\n* 300 mg of N-acetyl-cystein ;\n* 48.5 mg of zinc citrate (equivalent zinc pure element : 15 mg) ;\n* 35 mg of D-a-tocopherol (equivalent vitamin E pure element : 12 mg) ;\n* 16 mg of vitamin B3 ;\n* 1.8 mg of pyridoxin hydrochloride (equivalent vitamin B6 pure element : 1.4 mg) ;\n* 1.4 mg of vitamin B2 ;\n* 0.37 mg of (6S)-5-methyltetrahydrofolic acid, glucosamine salt (equivalent vitamin B9 pure element : 0.2 mg).\n\nSachets are packaged in box of 30.",[9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"OTHER","Placebo","1 sachet of placebo (2,1g) contains :\n\n* 1765.1 of maltodextrin ;\n* 300 mg of magnesium carbonate ;\n* 40 mg of citric acid ;\n* 5.3 mg of beta-carotene ;\n* 2.16 mg of silicon dioxide ;\n* 1.44 mg of sucralose.\n\nSachets are packaged in box of 30.",[15],[33],{"name":34,"affiliation":35,"role":36},"Nino-Guy Cassuto, PharmD","Laboratoire Drouot","PRINCIPAL_INVESTIGATOR",[38,44],{"name":39,"role":40,"phone":41,"phoneExt":42,"email":43},"Pierre-Yves Mousset, MD","CONTACT","616310400","+33","py.mousset@gynov.com",{"name":45,"role":40,"phone":46,"phoneExt":42,"email":47},"Axel Dries, Master","636630660","a.dries@gynov.com",[49],{"facility":35,"status":50,"city":51,"state":26,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"RECRUITING","Paris","75009","France","FR",{"type":56,"coordinates":57},"Point",[58,59],2.3488,48.85341,{"lat":59,"lon":58},[62,65],{"name":45,"role":40,"phone":63,"phoneExt":64,"email":47},"+33636630660","+33547742633",{"name":39,"role":40,"phone":66,"phoneExt":64,"email":43},"+33616310400",{"type":68,"investigatorFullName":5,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","Chief Executive Officer",[71],{"name":35,"class":72},"UNKNOWN","100436179","efficacy-study-of-a-food-supplement-with-myo-inositol-n-acetyl-cystein-zinc-and-vitamins-on-sperm-dna-fragmentation-100436179",false,"NCT04959864","Efficacy Study of a Food Supplement With Myo-inositol, N-Acetyl-Cystein, Zinc and Vitamins on Sperm DNA Fragmentation","Double-Blind Randomized Controlled Trial Evaluating the Efficacy of the Food Supplement Isitol® Versus Placebo on the Rate of Abnormal Sperm DNA Fragmentation","Selection Criteria:\n\n* Male patient volunteers aged 20 to 45 years (limits included);\n* Socially insured patient receiving benefits from the French Social Security's health branch\n\nNon-Selection Criteria:\n\n* Patients suffering from infertility of infectious or genetic origin, or from a pathology requiring concomitant medical treatment;\n* Consumption of dietary supplements during the previous 3 months and during the course of the study;\n* Smoking ≥ 5 cigarettes\u002Fday;\n* Alcoholism ≥ 10 drinks (alcohol standard)\u002Fweek ;\n* Body Mass Index (BMI) not between \\[19 and 29\\] (inclusive).\n* Occupation at risk of exposure to carcinogenic, mutagenic and toxic agents for reproduction defined according to articles R.4412-2 2°, R.4412-3 and R.4412-60 of the French Labour Code;\n* Patient unable to give consent;\n* Minors and protected adults, vulnerable persons;\n* Patient participating in another clinical research study\n\nInclusion Criteria:\n\n* Sperm DNA fragmentation rate ≥ 30 %\n\nExclusion Criteria:\n\n* Positive semen culture",true,"MALE","20 Years","45 Years",{"count":85,"type":86},72,"ESTIMATED","INTERVENTIONAL",[89],"NA","In industrialised countries, it is estimated that about 15% of couples who wish to have a child are currently facing infertility problems, of which, in half of the cases, an anomaly in sperm quality or at least a factor of male origin is identified. The evaluation of sperm quality in males is based, for the most part, on the micro and macroscopic examination of various parameters (concentration, motility, physical abnormalities of the spermatozoa, etc.). Nevertheless, an increasing number of scientific studies have shown that the quality of sperm DNA, and in particular its fragmentation rate, is also associated with a lower fertilisation rate. The integrity of sperm DNA may be affected by an imbalance in the Red\u002FOx balance leading to uncompensated oxidative stress, and could be restored or improved by dietary hygiene measures and the consumption of specific dietary products. The ISITOL clinical study aims to evaluate the efficacy of a dietary supplement specifically formulated to target the various issues associated with male infertility, and in particular to contribute to the improvement of the sperm DNA fragmentation rate. The efficacy of the dietary supplement Isitol® (GYNOV SAS) on sperm DNA fragmentation rate and other secondary parameters is being evaluated through a single-centre, prospective, randomised, double-blind, interventional vs. placebo clinical study being conducted in France at Laboratoire Drouot (21 Rue Drouot - 75009 Paris - France) and led by Dr. Nino-Guy Cassuto. A total of 72 men aged between 20 and 45 years, with sperm DNA fragmentation rate ≥ 30% and with negative semen culture are recruited. The recruited patients were randomized in a 1:1 scheme into 2 groups (Isitol® treated vs placebo treated).\n\n\\[Results to be reported later\\]",[92],"Male Infertility",[94,95,96,97,98],"Spermatozoa","DNA Fragmentation","Chromatin Condensation","Food supplement","TUNEL","2025-08-18",{"date":101,"type":102},"2025-08-22","ACTUAL",{"date":104,"type":102},"2021-07-07",{"date":106,"type":86},"2026-07",{"name":5,"class":6},1]