[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100520026":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":22,"centralContacts":27,"locations":33,"responsibleParty":51,"collaborators":54,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":11,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":79,"overallStatus":36,"whyStopped":11,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Erasmus Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Shared-Decision-Making group","EXPERIMENTAL",null,[13],"Other: ReceptIVFity test (vaginal microbiome swab)",{"label":15,"type":10,"description":11,"interventionNames":16},"Physician decision group",[13],[18],{"type":6,"name":19,"description":20,"armGroupLabels":21,"otherNames":11},"ReceptIVFity test (vaginal microbiome swab)","A vaginal self-swab for determination of the vaginal microbiome is performed by the patient.\n\nFor women of European origin randomization in one of the following groups:\n\nSDM group: Using Shared-Decision-Making according to the ReceptIVFity microbiome profile with its predicted chance of achieving a pregnancy in the current cycle.\n\nPhysician decision group: Postponing treatment until a switch to a favorable ReceptIVFity microbiome profile",[15,9],[23],{"name":24,"affiliation":25,"role":26},"Sam Schoenmakers, Dr. drs.","Erasmus MC Rotterdam","PRINCIPAL_INVESTIGATOR",[28],{"name":29,"role":30,"phone":31,"phoneExt":11,"email":32},"Xu Shan Gao, drs.","CONTACT","+31631016348","guvastudie@erasmusmc.nl",[34],{"facility":35,"status":36,"city":37,"state":11,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Erasmus University Medical Center","RECRUITING","Rotterdam","3015GD","Netherlands","NL",{"type":42,"coordinates":43},"Point",[44,45],4.47917,51.9225,{"lat":45,"lon":44},[48],{"name":29,"role":30,"phone":49,"phoneExt":11,"email":50},"0031631016348","receptivfitytest@erasmusmc.nl",{"type":26,"investigatorFullName":52,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Sam Schoenmakers","Principal Investigator",[55],{"name":56,"class":57},"The Dutch Healthcare Authority","UNKNOWN","100520026","innovation-for-small-scale-experiments-receptivfity-test-100520026",false,"NCT06051201","Innovation for Small-scale Experiments: ReceptIVFity Test","ReceptIVFity","Inclusion Criteria:\n\n1. Naïve IVF or IVF\u002FICSI patients\n2. Indication for an IVF or IVF-ICSI procedure.\n3. 18 years \\\u003C age \\\u003C 43 years.\n4. Willing to provide a vaginal swab with the ReceptIVFity test.\n5. Willing to provide informed consent.\n\nExclusion Criteria:\n\n1. The use of hormonal contraceptives at the time of taking the test.\n2. The use of antibiotic treatment at the time of taking the test.\n3. Emergency IVF for cancer or other reasons.\n4. Women with endometriosis pre-treated with an Gn-RH analogue.\n5. Women having IVF for egg preservation reasons.","FEMALE","18 Years","42 Years",{"count":69,"type":70},683,"ESTIMATED","INTERVENTIONAL",[73],"NA","The ReceptIVFity acts as a timing-tool for prediction of optimal pregnancy chances and provides insight into the patient's current (two months after sampling) success rate of an IVF\u002FIVF-ICSI treatment. Benefits of physician decision treatment in case of an unfavorable vaginal profile and a low chance of achieving a pregnancy include reducing unnecessary morbidity and treatment cycles, stress and disappointment, while increasing efficacy of the treatment and lowering the costs needed to achieve a pregnancy.\n\nThe goal of this prospective, clinical non-invasive randomized controlled study, with an additional observational study arm (for women of non-European origin) in naïve IVF or IVF\u002FICSI patients is to evaluate the efficiency of Shared Decision Making compared to Physician Decision in terms of\n\n1. the success probability of an IVF cycle,\n2. the proportion of women with a successful pregnancy\n3. the number of unsuccessful IVF cycles.\n\nRandomization component Women of European origin will be randomized 1:1 to either the shared decision group or the physician decision group. All women of European origin may undergo one to three cycles of IVF\u002FIVF-ICSI reimbursed by the health insurance. The follow-up ends after the outcome of the last of these cycles has been determined. The desired outcome of the IVF or IVF\u002FICSI treatment is a successful pregnancy, i.e., a pregnancy with a heart-beat at 12 weeks of gestation.\n\nObservational component Women of non-European origin are invited to take part in an observational component of this study. Without further evaluation of the results of their vaginal microbiome, they will continue with the IVF\u002FIVF-ICSI cycle. Women eligible for participation are naïve patients and the follow-up ends after the outcome of the first IVF\u002FIVF-ICSI cycle has been determined.",[76,77,78],"Pregnancy Related","Infertility, Female","Subfertility, Female",[80,81,82,83],"vaginal microbiome","IVF","IVF\u002FICSI","pregnancy","2024-09-12",{"date":86,"type":87},"2024-09-19","ACTUAL",{"date":89,"type":87},"2023-09-04",{"date":91,"type":70},"2027-09",{"name":5,"class":6},1]