[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100517064":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":23,"centralContacts":33,"locations":23,"responsibleParty":43,"collaborators":45,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":57,"sex":58,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":23,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":23,"overallStatus":70,"whyStopped":23,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":23},{"fullName":5,"class":6},"Medical University of Bialystok","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"metformin","EXPERIMENTAL","patients randomized to received metformin",[13],"Drug: Metformin Hydrochloride",{"label":15,"type":16,"description":17,"interventionNames":18},"placebo","PLACEBO_COMPARATOR","patients randomized to received placebo",[19],"Drug: Placebo",{"label":21,"type":22,"description":23,"interventionNames":23},"group without intervention","NO_INTERVENTION",null,[25,30],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":23},"DRUG","Metformin Hydrochloride","The investigational medicinal product\u002Fplacebo will be dispensed to study participants by study staff during randomization visits V1, V2, V3, V4, V5 and V6.\n\nThe randomized patient will receive the investigational medicinal product\u002Fplacebo in tablets of 500 mg. The received tablets will be dispensed in an amount sufficient for the next visit. Patients will be asked to bring unused medicine and all empty ones packaging to the Center for each subsequent visit. The investigational medicinal product\u002Fplacebo will be administered orally 500 mg three times a day (Table No. 1). The dose of the study product will be gradually increased from 500 mg\u002Fday to 1500 mg\u002Fday in order to avoid or reduce side effects related to taking the study medicinal product metformin",[9],{"type":26,"name":31,"description":28,"armGroupLabels":32,"otherNames":23},"Placebo",[15],[34,39],{"name":35,"role":36,"phone":37,"phoneExt":23,"email":38},"Monika Zbucka-Krętowska, Associate Professor","CONTACT","+48 85 831 87 89","monika.zbucka-kretowska@umb.edu.pl",{"name":40,"role":36,"phone":41,"phoneExt":23,"email":42},"Clinical Research Support Center","+48 85 686 53 86","owbk@umb.edu.pl",{"type":44,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR",[46],{"name":47,"class":48},"Medical Research Agency, Poland","OTHER_GOV","100517064","phase-2-clinical-trials-evaluating-the-effect-of-metformin-treatment-on-function-endometrium-in-women-diagnosed-with-idiopathic-infertility-100517064",false,"NCT06012682","Clinical Trials Evaluating the Effect of Metformin Treatment on Function Endometrium in Women Diagnosed With Idiopathic Infertility","A Randomized, Controlled, Double-blind Study Clinical Trials Evaluating the Effect of Metformin Treatment on Function Endometrium in Women Diagnosed With Idiopathic Infertility","METIN","Inclusion Criteria:\n\n1. Age 18-45\n2. No pregnancy for a minimum of 12 months prior to screening.\n3. Diagnosed with idiopathic infertility.\n4. No use of hormone therapy 30 days before screening.\n5. No use of any methods of contraception 30 days before screening and during the examination.\n6. BMI between 18.5 - 30 kg\u002Fm2.\n\nExclusion Criteria:\n\n1. Positive pregnancy test result.\n2. Patients diagnosed with another factor of infertility.\n3. Patients with type I or II diabetes.\n4. Patients taking metformin or other hypoglycaemic drugs in the last 4 weeks before screening.\n5. Patients with hepatic impairment and abnormal liver function tests (alanine aminotransferase and\u002For aspartate aminotransferase (above 3x ULN).\n6. Patients with an eGFR less than 45 mL\u002Fmin\u002F1.73m2.\n7. Accompanying chronic diseases with poor prognosis.\n8. Patients with a history of lactic acidosis or other metabolic acidosis.\n9. Patients with a history of congestive heart failure III\u002FIV NYHA degree.\n10. Patients with acute myocardial ischemia.\n11. Patients with sepsis or severe infection.\n12. Diseases which, in the opinion of the investigator, constitute an exclusion criterion and prevent the patient from participating in the study.\n13. Patients with predictable problems with cooperation with the research team.",true,"FEMALE","18 Years","45 Years",{"count":62,"type":63},200,"ESTIMATED","INTERVENTIONAL",[66],"PHASE2","Randomized, controlled, double-blind, three-arm clinical trial in which 75 women will be randomized to treatment with metformin, 75 women to treatment with placebo and 50 women to the observation group. The medical intervention will last 24 weeks (6 months). Women with confirmed idiopathic infertility, in whom infertility factors have been excluded during full diagnostics, will be included in the study",[69],"Infertility, Female","NOT_YET_RECRUITING","2023-08-22",{"date":73,"type":74},"2023-08-25","ACTUAL",{"date":76,"type":63},"2023-08-30",{"date":78,"type":63},"2027-09-30",{"name":5,"class":6}]