[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100619562":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":29,"locations":35,"responsibleParty":50,"collaborators":25,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":56,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":25,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":74,"overallStatus":83,"whyStopped":25,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"American Hospital 2 Kosovo","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"150 IU FSH Group","EXPERIMENTAL","Participants receive a fixed daily dose of 150 IU of recombinant or urinary FSH starting on day 2-3 of the menstrual cycle, continuing until trigger day.",[13],"Drug: Follicle-stimulating hormone (FSH)",{"label":15,"type":16,"description":17,"interventionNames":18},"225 IU FSH Group","ACTIVE_COMPARATOR","Participants receive a fixed daily dose of 225 IU of recombinant or urinary FSH starting on day 2-3 of the menstrual cycle, continuing until trigger day.",[13],[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Follicle-stimulating hormone (FSH)","Daily subcutaneous injection of 150 IU FSH",[9],null,{"type":21,"name":22,"description":27,"armGroupLabels":28,"otherNames":25},"Daily subcutaneous injection of 225 IU FSH",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},"Goksu Goc, MD","CONTACT","+38349878550","goksu.goc@gmail.com",[36],{"facility":37,"status":25,"city":38,"state":25,"zip":39,"country":40,"countryCode":25,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"American Hospital Kosova","Pristina","1000","Kosovo",{"type":42,"coordinates":43},"Point",[44,45],21.16688,42.67272,{"lat":45,"lon":44},[48],{"name":25,"role":32,"phone":25,"phoneExt":25,"email":49},"info@spitaliamerikan.com",{"type":51,"investigatorFullName":52,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Goksu Goc","Principal Investigator","100619562","phase-3-150-iu-vs-225-iu-fsh-in-normal-responders-the-optimal-dose-trial-100619562",false,"NCT07346235","150 IU vs. 225 IU FSH in Normal Responders: The OPTIMAL-DOSE Trial","OPTIMAL-DOSE: A Randomized, Open-Label, Non-Inferiority Trial Comparing Fixed Daily Doses of 150 IU Versus 225 IU of Follicle-Stimulating Hormone in Predicted Normal Responders Undergoing In Vitro Fertilization\u002FIntracytoplasmic Sperm Injection","OPTIMAL-DOSE","Inclusion Criteria:\n\n1. Body Mass Index (BMI) 18-30 kg\u002Fm².\n2. Predicted normal ovarian reserve:\n3. Anti-Müllerian Hormone (AMH) 1.2-3.5 ng\u002FmL (measured within 12 months), AND Antral Follicle Count (AFC) 8-20 (both ovaries combined, measured on day 2-5 of the cycle).\n4. First or second IVF\u002FICSI cycle.\n5. Planned GnRH antagonist protocol.\n6. Both ovaries present and accessible.\n7. Written informed consent provided voluntarily.\n\nExclusion Criteria:\n\n1. Predicted poor or high ovarian response (AMH \\\u003C1.2 or \\>3.5 ng\u002FmL; AFC \\\u003C8 or \\>20).\n2. Polycystic Ovary Syndrome (PCOS) according to Rotterdam criteria.\n3. Severe endometriosis (Stage III-IV per ASRM).\n4. Severe uterine abnormalities affecting implantation.\n5. Previous complete fertilization failure (fertilization rate \\\u003C30%).\n6. Severe male factor (sperm count \\\u003C5 million\u002FmL, or requirement for donor sperm\u002FTESE).\n7. Uncontrolled endocrine disorders (uncontrolled hypothyroidism, hyperprolactinemia, diabetes).\n8. Contraindications to pregnancy or gonadotropins.\n9. Participation in another clinical trial within 30 days.\n10. Inability to provide informed consent.","FEMALE","18 Years","39 Years",{"count":66,"type":67},440,"ESTIMATED","INTERVENTIONAL",[70],"PHASE3","This is a single-center, randomized, open-label, non-inferiority trial comparing two fixed daily doses of follicle-stimulating hormone (FSH): 150 IU versus 225 IU in women with predicted normal ovarian response undergoing in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) with a gonadotropin releasing hormone (GnRH) antagonist protocol. The primary objective is to determine whether the 150 IU dose is noninferior to the 225 IU dose regarding the cumulative live birth rate per initiated cycle. Secondary objectives include comparing oocyte yield, incidence of OHSS, treatment costs, and patient-reported outcomes.",[73],"Infertility, Female",[75,76,77,78,79,80,81,82],"IVF","ICSI","FSH","Gonadotropin","Ovarian Stimulation","Normal Responder","Live Birth Rate","OHSS","NOT_YET_RECRUITING","2026-01-08",{"date":86,"type":87},"2026-01-16","ACTUAL",{"date":89,"type":67},"2026-03-01",{"date":91,"type":67},"2029-01-15",{"name":5,"class":6},1]