[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658729":3},{"organization":4,"outcomesModule":7,"designInfo":26,"detailedDescription":37,"studyPopulation":25,"armGroups":38,"interventions":51,"overallOfficials":61,"centralContacts":66,"locations":76,"responsibleParty":97,"collaborators":25,"id":101,"slug":102,"hasResults":103,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":25,"eligibilityCriteria":107,"healthyVolunteers":103,"sex":108,"minAge":109,"maxAge":110,"enrollmentInfo":111,"targetDuration":25,"studyType":114,"phases":115,"briefSummary":118,"conditions":119,"keywords":121,"overallStatus":79,"whyStopped":25,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":135},{"fullName":5,"class":6},"Stochastic Research Technologies LLC","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":25},[9],{"measure":10,"description":11,"timeFrame":12},"Total Gonadotropin dosage","Total Dosage","11 days",[14,17,21],{"measure":15,"description":15,"timeFrame":16},"M2 Oocytes","13 days",{"measure":18,"description":19,"timeFrame":20},"Total Embryos","Number of Embryos","15 days",{"measure":22,"description":23,"timeFrame":24},"Grade A Blastocysts","No. of Grade A blastocysts","20 days",null,{"allocation":27,"interventionModel":28,"interventionModelDescription":29,"primaryPurpose":30,"observationalModel":25,"timePerspective":25,"maskingInfo":31},"RANDOMIZED","PARALLEL","This is a single-site cohort with two arms (one arm for the intervention and one arm for the traditional approach), a randomized clinical trial involving more than 100 patients.","TREATMENT",{"masking":32,"maskingDescription":33,"whoMasked":34},"DOUBLE","The clinicians, participants, and outcome assessors will be blinded to treatment assignment. Only the research coordinator will be aware of the treatment assignment.",[35,36],"PARTICIPANT","OUTCOMES_ASSESSOR","This will be a two-arm randomized clinical trial involving more than 100 patients; one arm will undergo superovulation using dosages predicted by the decision-support tool, while the other will receive the current standard treatment. The research question is whether outcomes of patient dosage treatment using Opt-IVF are better or similar to the current practice. We will compare the outcomes of the two groups of patients in terms of the numbers and percentage of mature follicles retrieved at the end of each cycle, total FSH and HMG dosages used, and the number of required testing days for that cycle, total number of M2s, Number of embryos, Number of Grade A embryos, and Number of Grade A blastocysts.",[39,45],{"label":40,"type":41,"description":42,"interventionNames":43},"Opt-IVF","EXPERIMENTAL","Opt-IVF 1.0 arm will receive personalized total-gonadotropin optimization predicted dosage per day",[44],"Device: Opt-IVF",{"label":46,"type":47,"description":48,"interventionNames":49},"Control","ACTIVE_COMPARATOR","This standard-care arm will receive physician-directed dosing",[50],"Other: control",[52,56],{"type":53,"name":40,"description":54,"armGroupLabels":55,"otherNames":25},"DEVICE","Opt-IVF predicted dosage for IVF",[40],{"type":57,"name":58,"description":59,"armGroupLabels":60,"otherNames":25},"OTHER","control","Doctor prescribed dosage",[46],[62],{"name":63,"affiliation":64,"role":65},"Dr. Paul Magarelli, M.D., Ph.D.","The American Baby Company","PRINCIPAL_INVESTIGATOR",[67,72],{"name":68,"role":69,"phone":70,"phoneExt":25,"email":71},"Urmila Diwekar, Ph.D.","CONTACT","6308863047","urmila@opt-ivf.com",{"name":73,"role":69,"phone":74,"phoneExt":25,"email":75},"Sanjay Joag, M.D., Ph.D.","6305014451","sanjay@opt-iVF.com",[77],{"facility":78,"status":79,"city":80,"state":81,"zip":82,"country":83,"countryCode":84,"cosmosGeoPoint":85,"geoPoint":90,"contacts":91},"ABC IVF","RECRUITING","West Palm Beach","Florida","33407","United States","US",{"type":86,"coordinates":87},"Point",[88,89],-80.05337,26.71534,{"lat":89,"lon":88},[92,95],{"name":63,"role":69,"phone":93,"phoneExt":25,"email":94},"630-886-3047","paul@americanbabyco.com",{"name":96,"role":69,"phone":74,"phoneExt":25,"email":75},"Dr. Sanjay Joag, M.D., Ph.D.",{"type":98,"investigatorFullName":99,"investigatorTitle":100,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"SPONSOR_INVESTIGATOR","Urmila DIwekar","President","100658729","phase-1-opt-ivf-for-personalized-medicine-for-normal-responders-100658729",false,"NCT07856082","Opt-IVF for Personalized Medicine for Normal Responders","The Advanced Decision Support Tool, Opt-IVF for Personalized Medicine for IVF Antagonist and Progesterone-Primed Ovarian Stimulation (PPOS) Protocol for Normal Responders","Inclusion Criteria:\n\nNormal Responders\n\nExclusion Criteria:\n\n* PCOS and Poor Responders","FEMALE","20 Years","50 Years",{"count":112,"type":113},100,"ESTIMATED","INTERVENTIONAL",[116,117],"PHASE1","PHASE2","A clinical trial will determine the effectiveness of the Opt-IVF decision-support tool in generating personalized, optimal drug-dosage profiles for each patient in the United States.",[120],"Ivf",[122,123,124,125],"Infertility","IVF","Antagonist","PPOS","2026-09-28",{"date":128,"type":129},"2026-10-02","ACTUAL",{"date":131,"type":113},"2026-10-15",{"date":133,"type":113},"2027-04-30",{"name":99,"class":6},1]