[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100465657":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":34,"responsibleParty":49,"collaborators":20,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":20,"eligibilityCriteria":59,"healthyVolunteers":60,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":20,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":75,"overallStatus":37,"whyStopped":20,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Yale University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Endometrial Disorders","EXPERIMENTAL","Three groups of patients, with 10 subjects per group:\n\n1. Asherman's syndrome, as classified by the American Society of Reproductive Medicine (ASRM) by extent of uterine cavity involvement and adhesion type. Specifically, refractory Asherman's syndrome: patients who have had at least one operative hysteroscopy which was unsuccessful.\n2. Atrophic endometrium, as defined by maximal endometrial lining thickness ≤6mm documented in at least 2 cycles on either:\n\n   * Day of luteinizing hormone (LH) surge in natural cycle\n   * Day of human chorionic gonadotropin (hCG) trigger in the setting of fresh IVF cycle\n   * Day 14 of estradiol in the setting of frozen embryo transfer things (FET) cycles\n3. Recurrent implantation failure, defined as failure to achieve a clinical pregnancy after transfer of at least four good-quality embryos in a minimum of three fresh or frozen transfer cycles in a woman under 40 years",[13],"Drug: Plerixafor",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Plerixafor","A 20mg single dose of PLERIXAFOR is administered subcutaneously the evening prior to scheduled standard of care surgery for women with AS, AE or RIF for peripheral mobilization of stem cells. For subjects weighing \\>83 kilogram, the dosing is a single dose of 0.24 milligram per kilogram.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Hugh Taylor, MD","PRINCIPAL_INVESTIGATOR",[26,31],{"name":27,"role":28,"phone":29,"phoneExt":20,"email":30},"Hugh S Taylor, MD","CONTACT","(203)-785-6949","hugh.taylor@yale.edu",{"name":32,"role":28,"phone":29,"phoneExt":20,"email":33},"Michele Frank, BSN","Michele.Frank@yale.edu",[35],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":20},"Yale Fertility Center","RECRUITING","Orange","Connecticut","06477","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-73.02566,41.27843,{"lat":47,"lon":46},{"type":50,"investigatorFullName":51,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"SPONSOR_INVESTIGATOR","Hugh Taylor","Chair of Obstetrics, Gynecology and Reproductive Sciences","100465657","early-phase-1-bone-marrow-derived-stem-cells-mobilization-for-treatment-of-abnormal-endometrium-100465657",false,"NCT05343572","Bone Marrow Derived Stem Cells Mobilization for Treatment of Abnormal Endometrium","Bone Marrow Derived Stem Cells Mobilization for Treatment of Asherman's Syndrome, Atrophic Endometrium, and Recurrent Implantation Failure","Inclusion Criteria:\n\n* Healthy, non pregnant females\n* ages ≥18 and ≤40 years old at time of enrollment\n* with either AS, AE, or RIF\n\n  1. For AS: surgical history of intrauterine trauma\u002Finfection, hypo\u002Famenorrhea, intra-uterine adhesions\n  2. for AE: US documentation of persistent, \\\u003C6mm endometrial thickness\n  3. for RIF: failure to achieve a clinical pregnancy after transfer of at least four good-quality embryos in a minimum of three fresh or frozen cycles in a woman under 40 years and currently being treated at Yale Fertility Clinic\n\nExclusion Criteria:\n\n* Presence of hydrosalpinx (diagnosed by radiographic or ultrasound imaging)\n* Endometriosis (diagnosed by previous surgery,)\n* Diminished ovarian reserve (AMH\\\u003C1ng\u002Fml or follicle stimulating hormone (FSH)\\>10)\n* History of genital tuberculosis or any ultrasound evidence of congenital uterine anomaly\n* Submucous or intracavitary fibroid, polyps\n* Currently pregnant\n* Personal history of thrombophilia or sickle cell disease\n* Inability to provide informed consent",true,"FEMALE","18 Years","40 Years",{"count":65,"type":66},90,"ESTIMATED","INTERVENTIONAL",[69],"EARLY_PHASE1","This study will assess the use of autologous bone marrow stem cells mobilization using 1,1'-\\[1,4-phenylenebis-(methylene)\\]-bis-1,4,8,11-tetraazacyclotetradecane (PLERIXAFOR) as an effective medical therapy for the treatment of Asherman's Syndrome (AS), Atrophic Endometrium (AE) and Recurrent Implantation Failure (RIF).",[72,73,74],"Asherman Syndrome","Atrophic Endometrium","Recurrent Implantation Failure",[76],"bone marrow derived stem cells","2025-11-07",{"date":79,"type":80},"2025-11-12","ACTUAL",{"date":82,"type":80},"2023-11-01",{"date":84,"type":66},"2027-12",{"name":51,"class":6},1]