[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100498818":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":25,"locations":32,"responsibleParty":48,"collaborators":18,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":18,"eligibilityCriteria":56,"healthyVolunteers":57,"sex":58,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":18,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":71,"overallStatus":34,"whyStopped":18,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Nadezhda Women's Health Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intrauterine administration of PBMC immunomodulated with IFNt","EXPERIMENTAL","Approximately 9 ml whole blood will be collected from each patient 5 days post LH peak by peripheral venipuncture using a 21G butterfly catheter affixed via vacutainer to negative pressure receiving tubes (BD vacutainer acid-citrate-dextrose (ACD-A), REF:366645). PBMC will be isolated by density gradient centrifugation in room-temperature centrifuge set to 400 g for 25 min. After washing the obtained PBMCs, they will be suspended in RPMI 1640 supplemented with 10% HSA (human serum albumin) and incubated in the presence of 500 IU\u002Fml IFNt for 24 h at 37˚C. On day 6 after LH peak, this cultured cell suspension will be carefully introduced in the uterine cavity by catheter. The following day (LH+7), patients will undergo a standard embryo transfer (ET) procedure.",[13],"Biological: PBMC immunomodulated with IFNt",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Group","NO_INTERVENTION","Participants will undergo standard embryo transfer procedure with no intervention.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"BIOLOGICAL","PBMC immunomodulated with IFNt","Autologous peripheral blood mononuclear cells (PBMC) isolated using a standard protocol will be cultured in the presence of interferon tau (IFNt) for 24 hours at 37 ˚C and administered in the uterine cavity of patients 1 day prior to embryo transfer.",[9],[26],{"name":27,"role":28,"phone":29,"phoneExt":30,"email":31},"Dimitar Parvanov, PhD","CONTACT","885944618","359","dimparvanov@abv.bg",[33],{"facility":5,"status":34,"city":35,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":18,"geoPoint":18,"contacts":39},"RECRUITING","Sofia","1330","Bulgaria","BG",[40,44],{"name":41,"role":28,"phone":42,"phoneExt":30,"email":43},"Georgi Stamenov, MD","888269839","g.stamenov@abv.bg",{"name":45,"role":28,"phone":46,"phoneExt":30,"email":47},"Margarita Ruseva, MSc","889150267","margarita.ruseva@gmail.com",{"type":49,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100498818","effect-of-intrauterine-administration-of-autologous-pbmc-modulated-with-ifnt-on-ivf-outcome-100498818",false,"NCT05775198","Effect of Intrauterine Administration of Autologous PBMC Modulated With IFNt on IVF Outcome","Effects of Intrauterine Administration of Autologous Peripheral Blood Mononuclear Cells (PBMC) Immunomodulated With Interferon Tau (IFNt) Prior to Embryo Transfer on IVF Outcome","Inclusion Criteria:\n\n* Participating in Assisted Reproduction Treatment\n* Having primary infertility\n* Having regular menstrual cycles\n* Scheduled to undergo embryo transfer of euploid embryos only\n\nExclusion Criteria:\n\n* Uterine pathologies\n* Endometrial bacterial infections\n* Active endometrial inflammation\n* Polycystic ovary syndrome\n* Presence of auto antibodies such as anti-TPO (thyroid peroxidase), anti-TG (thyroglobulin), ACA (anticentromere antibodies), APA (antiphospholipid antibodies), ANA (antinuclear antibodies), and anti-dsDNA\n* Presence of mutations involving the coagulation system such as deficiency of factor XII, Pro C, Pro S\n* Oncological condition\n* Positive HIV (human immunodeficiency virus), HCV (hepatitis C virus) or HBV (hepatitis B virus) tests",true,"FEMALE","18 Years","50 Years",{"count":62,"type":63},300,"ESTIMATED","INTERVENTIONAL",[66],"NA","The goal of this clinical trial is to test the effect of modulated specialised immune cells isolated from the patients' own blood when administered to the uterus before embryo transfer on the IVF outcome (implantation, pregnancy and live birth rates).\n\nTo achieve this, blood will be obtained from eligible participants. Target cells will be isolated and incubated with the tested modulator for 24h, and returned to the uterine cavity 1 day prior to embryo transfer.\n\nResearchers will compare the reproductive outcome of the tested intervention to that of a control group who will not receive the investigated cell treatment prior to embryo transfer.",[69,70],"Infertility, Female","IVF",[72,73,74,75,76],"intrauterine PBMC","interferon tau","implantation","clinical pregnancy","live birth rate","2025-05-20",{"date":79,"type":80},"2025-05-21","ACTUAL",{"date":82,"type":80},"2023-03-01",{"date":84,"type":63},"2026-04-28",{"name":5,"class":6},1]