[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100290316":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":38,"centralContacts":42,"locations":49,"responsibleParty":66,"collaborators":68,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":77,"sex":83,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":33,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":96,"overallStatus":52,"whyStopped":33,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"University Hospital, Lille","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Myo-Inositol + Levomefolic acid","EXPERIMENTAL","The experimental group will receive the dietary supplement: 4 g of MYO + 0.736 mg of 5-MTHF, glucosamine salts per day per os (in 2 bags per day) in addition to the standard therapy (Clomiphene Citrate).",[13,14],"Dietary Supplement: Myo-Inositol + Levomefolic acid","Drug: Clomiphene Citrate",{"label":16,"type":17,"description":18,"interventionNames":19},"Placebo","PLACEBO_COMPARATOR","The control group will receive the standard therapy ( Clomiphene Citrate) and a placebo containing only 0.736 mg of 5-MTHF, glucosamine salts",[14,20],"Dietary Supplement: placebo",[22,28,34],{"type":23,"name":9,"description":24,"armGroupLabels":25,"otherNames":26},"DIETARY_SUPPLEMENT","Dietary supplement Gynositol® MTHF containing myo-inositol (4 g) and Levomefolic acid on glucosamine salts(0.736 mg) in a same bags Supplementation started on average one month before treatment with Clomiphene citrate and continued throughout cycles of Clomiphene citrate (maximum 9 cycles). Treatment will be delivered during ultrasound visit at D12 of each cycle.",[9],[27],"Myo + [6S]-5-MethylTetrahydrofolate(5-MTHF) ou Gynositol (R)",{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"DRUG","Clomiphene Citrate","Clomiphene citrate 50 mg. taking D2 to D6 of each cycle (maximum 9 cycles). Treatment will be delivered during ultrasound visit at D12 of each cycle and the dose will be increased if necessary.",[9,16],null,{"type":23,"name":35,"description":36,"armGroupLabels":37,"otherNames":33},"placebo","a placebo containing only 0.736 mg of 5-MTHF, glucosamine salts",[16],[39],{"name":40,"affiliation":5,"role":41},"Goeffrey Robin, MD","PRINCIPAL_INVESTIGATOR",[43],{"name":44,"role":45,"phone":46,"phoneExt":47,"email":48},"Goeffrey ROBIN, MD","CONTACT","320446252","+33","goeffrey.robin@chru-lille.fr",[50],{"facility":51,"status":52,"city":53,"state":33,"zip":33,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"CHU de Lille hôpital Jeanne de Flandre","RECRUITING","Lille","France","FR",{"type":57,"coordinates":58},"Point",[59,60],3.05512,50.63391,{"lat":60,"lon":59},[63,65],{"name":64,"role":45,"phone":33,"phoneExt":33,"email":33},"Geoffroy Robin, MD, PhD",{"name":64,"role":41,"phone":33,"phoneExt":33,"email":33},{"type":67,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR",[69,72],{"name":70,"class":71},"Ministry of Health, France","OTHER_GOV",{"name":73,"class":74},"Laboratoires Besins International","INDUSTRY","100290316","phase-3-interest-of-myo-inositol-supplementation-in-women-with-polycystic-ovarian-syndrome-100290316",false,"NCT03059173","Interest of Myo-inositol Supplementation in Women With Polycystic Ovarian Syndrome","Interest of Myo-inositol Supplementation in Women With Polycystic Ovarian Syndrome During Induction of Ovulation With Clomiphene Citrate","MYOPK","Inclusion Criteria:\n\n* Wishing pregnancy,\n* Having PCOS defined by the Rotterdam criteria: high antral follicle count (AFC) (\\> 19 per ovary) and\u002For a disorder of the cycle and\u002For hyperandrogenism (at least two of the three criteria),\n* Having never been treated with CC (or previous treatment with CC interrupted for \\> 3 months).\n* Having received complete information and having signed consent.\n* Covered by social security\n\nExclusion Criteria:\n\n* Intolerance to CC in previous treatment,\n* BMI \\> 35,\n* Other associated cause of oligoanovulation requiring specific treatment (eg., Hyperprolactinemia or functional hypothalamic anovulation),\n* Ongoing pregnancy at the time of CC initiation,\n* Other male or female cause of hypo-fertility,\n* History of ovarian drilling,\n* Negative rubella serology.","FEMALE","18 Years","35 Years",{"count":87,"type":88},276,"ESTIMATED","INTERVENTIONAL",[91],"PHASE3","The main objective will be to check if MyoInositol (MYO) reduces the total resistance rate to Clomiphene Citrate (CC). For this, our study will be controlled, randomized and double blinded. It will include patients with PCOS (polycystic ovary syndrome, defined by the Rotterdam criteria) who wish to become pregnant and are eligible to simple ovulation induction by CC. Half of them will receive MYO + levomefolic acid (5-MTHF) in addition to the CC, while the other half will receive a placebo containing only 5-MTHF in addition to the CC. The MYO supplementation will be initiated at least one month before taking CC and will be continued throughout this treatment until pregnancy or before switching to another type of treatment for ovulation induction if no pregnancy is obtained after 6 ovulatory cycles.",[94,95],"Polycystic Ovary Syndrome","Reproductive Medicine",[97,98],"Polycystic ovary syndrome","Reproductive medicine","2026-04-17",{"date":101,"type":102},"2026-04-22","ACTUAL",{"date":104,"type":102},"2023-09-12",{"date":106,"type":88},"2027-12",{"name":5,"class":6},1]