[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100324720":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":28,"centralContacts":33,"locations":41,"responsibleParty":118,"collaborators":10,"id":121,"slug":122,"hasResults":123,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":10,"eligibilityCriteria":127,"healthyVolunteers":123,"sex":128,"minAge":129,"maxAge":130,"enrollmentInfo":131,"targetDuration":10,"studyType":134,"phases":10,"briefSummary":135,"conditions":136,"keywords":10,"overallStatus":44,"whyStopped":10,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":147},{"fullName":5,"class":6},"University of Luebeck","OTHER",[8,13,16,19],{"label":9,"type":10,"description":10,"interventionNames":11},"Progynova\u002FDydrogesterone",null,[12],"Diagnostic Test: Blood samples and microbiological swaps",{"label":14,"type":10,"description":10,"interventionNames":15},"Spontaneous cycle",[12],{"label":17,"type":10,"description":10,"interventionNames":18},"Progynova\u002FCrinone",[12],{"label":20,"type":10,"description":10,"interventionNames":21},"Others Medication",[12],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":10},"DIAGNOSTIC_TEST","Blood samples and microbiological swaps","Blood analysis and analysis of vaginal microbiota.",[20,17,9,14],[29],{"name":30,"affiliation":31,"role":32},"Georg Griesinger, MD","Sektion für gynäkologische Endokrinologie und Reproduktionsmedizin","PRINCIPAL_INVESTIGATOR",[34,38],{"name":30,"role":35,"phone":36,"phoneExt":10,"email":37},"CONTACT","+49451 50577810","georg.griesinger@uni-luebeck.de",{"name":39,"role":35,"phone":36,"phoneExt":10,"email":40},"Tanja Eggersmann, MD","tanja.eggersmann@uksh.de",[42,64,81,98,112],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"IVF-SAAR","RECRUITING","Saarbrücken","Saarland","66113","Germany","DE",{"type":51,"coordinates":52},"Point",[53,54],7.00982,49.23262,{"lat":54,"lon":53},[57,61],{"name":58,"role":35,"phone":59,"phoneExt":10,"email":60},"Sascha Tauchert, MD","0681-93632-0","S.Tauchert@ivf-saar.de",{"name":62,"role":35,"phone":59,"phoneExt":10,"email":63},"Lars Happel, MD","zentrum@ivf-saar.de",{"facility":65,"status":44,"city":66,"state":67,"zip":68,"country":48,"countryCode":49,"cosmosGeoPoint":69,"geoPoint":73,"contacts":74},"Universitäres Kinderwunschzentrum Lübeck","Lübeck","Schleswig-Holstein","23562",{"type":51,"coordinates":70},[71,72],10.68729,53.86893,{"lat":72,"lon":71},[75,79],{"name":76,"role":35,"phone":77,"phoneExt":10,"email":78},"Georg Griesinger, Prof Dr MSc","+49 451 50577810","georg.griesinger@uksh.de",{"name":39,"role":35,"phone":77,"phoneExt":10,"email":80},"tanjakristina.eggersmann@uksh.de",{"facility":82,"status":44,"city":83,"state":10,"zip":84,"country":48,"countryCode":49,"cosmosGeoPoint":85,"geoPoint":89,"contacts":90},"Universitätsklinikum Düsseldorf,UniKiD","Düsseldorf","40225",{"type":51,"coordinates":86},[87,88],6.77927,51.22319,{"lat":88,"lon":87},[91,95],{"name":92,"role":35,"phone":93,"phoneExt":10,"email":94},"Philippos Edimiris, MD","+49 211 81-04060","edimiris@unikid.de",{"name":96,"role":35,"phone":93,"phoneExt":10,"email":97},"Jan S Krüssel, Prof. Dr.","Jan-Steffen.Kruessel@med.uni-duesseldorf.de",{"facility":99,"status":44,"city":100,"state":10,"zip":101,"country":48,"countryCode":49,"cosmosGeoPoint":102,"geoPoint":106,"contacts":107},"Universitäres Kinderwunschzentrum","Kiel","24105",{"type":51,"coordinates":103},[104,105],10.13489,54.32133,{"lat":105,"lon":104},[108],{"name":109,"role":35,"phone":110,"phoneExt":10,"email":111},"Sören von Otte, PD Dr.","0431 500-92220","soeren.vonotte@uksh.de",{"facility":5,"status":44,"city":66,"state":10,"zip":10,"country":48,"countryCode":49,"cosmosGeoPoint":113,"geoPoint":115,"contacts":116},{"type":51,"coordinates":114},[71,72],{"lat":72,"lon":71},[117],{"name":30,"role":35,"phone":10,"phoneExt":10,"email":37},{"type":32,"investigatorFullName":119,"investigatorTitle":120,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Prof. Dr. med. M.Sc. Georg Griesinger","Professor","100324720","clinical-cohort-study-on-the-endocrinology-and-vaginalendometrial-microbiome-of-the-luteal-phase-in-assisted-reproduction-100324720",false,"NCT03507673","Clinical Cohort Study on the Endocrinology and Vaginal\u002FEndometrial Microbiome of the Luteal Phase in Assisted Reproduction","Prospective, Clinical Cohort Study on the Endocrinology and Vaginal\u002FEndometrial Microbiome of the Luteal Phase and Pregnancy After Embryo Transfer in Assisted Reproduction","Inclusion Criteria:\n\n1. Patients aged 18 to 45 years\n2. Transfer of cryopreserved embryos\n\nExclusion Criteria:\n\n1. Fresh IVF\u002FICSI embryo transfer cycle\n2. Evidence for ovulation on ultrasound previous to embryo transfer confirmed by a follicle ≥14mm or by a progesterone ≥1.0 µg\u002Fl in programmed cycles\n3. Uterus malformations, endometrial abnormalities (on ultrasound or diagnosed by previous hysteroscopy)","FEMALE","18 Years","45 Years",{"count":132,"type":133},1200,"ESTIMATED","OBSERVATIONAL","Rationale:\n\nThe hormone progesterone has different functions. In pregnancy, it is vital for maintenance thereof. In early pregnancy, progesterone is synthesized by the Corpus luteum (CL). Its production shifts from the CL to the placenta after several gestational weeks. This process is termed luteoplacental shift. Still, the exact time point of the luteoplacental shift remains unknown. Furthermore, the characteristics of placental progesterone increase and its relevance for the course of pregnancy has not been studied so far.\n\nFurthermore, recent studies have shown an influence of abnormal vaginal microbiota on the likelihood to achieve and maintain pregnancy. Little is known about possible crosslinks between endocrinology and vaginal\u002Fendometrial microbiota which is why this study aims to investigate possible associations of such kind.\n\nObjective:\n\nThe primary objective of this study is to evaluate the time point of the luteoplacental shift in patients achieving pregnancy after transfer of cryopreserved embryos subsequently to IVF\u002FICSI cycles. Secondary objectives are to study the characteristics of the placental progesterone increase and its function as a predictor of the course and development of pregnancies and to study vaginal\u002Fendometrial microbiota at baseline and changes associated with shift into luteal phase and early pregnancy and how this potentially relates to pregnancy outcome.\n\nStudy Design:\n\nProspective, multi-center, observational clinical cohort study. For the primary objective, data from a single center will be also be retrospectively analyzed.\n\nStudy population:\n\nFemale patients aged 18 to 45 years undergoing transfer of embryos after freezing and thawing 2PN oocytes or embryos.\n\nInterventions: Blood withdrawal, vaginal\u002Fendometrial swabs and endocrine and microbiom analyses.\n\nStudy parameters\u002Fendpoints:\n\nThe main parameter is time point of progesterone increase in pregnancy in relation to initial progesterone levels by pregnancy status. Secondary, slope and magnitude of placental progesterone increase and its relevance as a predictor for the course and development of pregnancies\u002Fbabies. Furthermore, vaginal microbiota of women undergoing embryo transfer and of women in early pregnancy are parameter of this study.",[137],"Infertility","2025-05-21",{"date":140,"type":141},"2025-05-22","ACTUAL",{"date":143,"type":141},"2018-05-02",{"date":145,"type":133},"2028-06-30",{"name":5,"class":6},5]