[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100480619":3},{"organization":4,"outcomesModule":7,"designInfo":19,"detailedDescription":30,"studyPopulation":18,"armGroups":31,"interventions":44,"overallOfficials":18,"centralContacts":53,"locations":61,"responsibleParty":82,"collaborators":18,"id":84,"slug":18,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":85,"sex":91,"minAge":92,"maxAge":93,"enrollmentInfo":94,"targetDuration":18,"studyType":97,"phases":98,"briefSummary":100,"conditions":101,"keywords":18,"overallStatus":63,"whyStopped":18,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"Reproductive Medicine Associates of New Jersey","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":18},[9],{"measure":10,"description":11,"timeFrame":12},"Endometrial Thickness during frozen embryo transfer","peak endometrial thickness prior to initiation of progesterone","during the proliferative phase of the frozen embryo transfer cycle",[14],{"measure":15,"description":16,"timeFrame":17},"Sustained implantation rate","presence of fetal heart beat upon discharge from care","approximately 9 weeks gestational age",null,{"allocation":20,"interventionModel":21,"interventionModelDescription":18,"primaryPurpose":22,"observationalModel":18,"timePerspective":18,"maskingInfo":23},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":24,"maskingDescription":18,"whoMasked":25},"QUADRUPLE",[26,27,28,29],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","Patients with a history of thin endometrium will be randomized to either an intrauterine infusion of PRP vs. a placebo infusion of normal saline. This is a double-blind, placebo controlled prospective RCT. Patients will then proceed with a frozen embryo transfer of a single euploid embryo per routine.",[32,38],{"label":33,"type":34,"description":35,"interventionNames":36},"Intervention Group","ACTIVE_COMPARATOR","an intrauterine infusion of platelet rich plasma (PRP) will be administered to this group",[37],"Other: Platelet Rich Plasma Intrauterine infusion",{"label":39,"type":40,"description":41,"interventionNames":42},"Control Group","PLACEBO_COMPARATOR","an intrauterine infusion of normal saline will be administered to this group",[43],"Other: Normal saline Intrauterine infusion",[45,49],{"type":6,"name":46,"description":47,"armGroupLabels":48,"otherNames":18},"Platelet Rich Plasma Intrauterine infusion","an intrauterine infusion of platelet rich plasma (PRP) will be administered to this group of participants",[33],{"type":6,"name":50,"description":51,"armGroupLabels":52,"otherNames":18},"Normal saline Intrauterine infusion","an intrauterine infusion of normal saline will be administered to this group of participants",[39],[54,59],{"name":55,"role":56,"phone":57,"phoneExt":18,"email":58},"Christine V Whitehead, BSN, RN","CONTACT","19736562841","clinicalresearchteam@ivirma.com",{"name":60,"role":56,"phone":57,"phoneExt":18,"email":58},"Caroline Zuckerman, BS",[62],{"facility":5,"status":63,"city":64,"state":65,"zip":66,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":74,"contacts":75},"RECRUITING","Basking Ridge","New Jersey","07920","United States","US",{"type":70,"coordinates":71},"Point",[72,73],-74.54932,40.70621,{"lat":73,"lon":72},[76,78,79],{"name":55,"role":56,"phone":57,"phoneExt":18,"email":77},"cwhitehead@ivirma.com",{"name":60,"role":56,"phone":57,"phoneExt":18,"email":58},{"name":80,"role":81,"phone":18,"phoneExt":18,"email":18},"Jason Franasiak, MD","PRINCIPAL_INVESTIGATOR",{"type":83,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100480619",false,"NCT05538338","Platelet Rich Plasma for Insufficient Endometrium","Intrauterine Platelet Rich Plasma (PRP) Infusion for Endometrial Insufficiency: A Prospective, Double-Blind, Placebo-Controlled Randomized Controlled Trial","PIER","Inclusion Criteria:\n\n* Patients who have previously undergone at least 2 unsuccessful frozen embryo transfer cycles, defined as failure to achieve a sustained clinical pregnancy (visualization of intrauterine gestational sac on ultrasound or a cancelled embryo transfer cycle due to inadequate endometrial thickness\n* Patients with a diagnosis of thin endometrial lining (less than or equal to 6 mm maximum thickness) during prior unsuccessful or canceled embryo transfer cycles.\n\nExclusion Criteria:\n\n* Fewer than 2 prior unsuccessful or canceled frozen embryo transfer cycles.\n* Most recent unsuccessful embryo transfer prior to January 1, 2017.\n* Mullerian anomalies, excluding arcuate uterus\n* Concurrent submucosal fibroids, unrepaired uterine defects or present indication for uterine surgery\n* Communicating hydrosalpinx without plans for surgical correction prior to study enrollment.\n* Failure of patient to agree to enrollment in study with written consent.\n* Concurrent pregnancy\n* Anticoagulation use for which plasma infusion is contraindicated\n* History of thrombosis\n* Thrombophilia either inherited or acquired\n* Concomitant use of adjunctive therapies for proliferation. These must be discontinued upon enrollment.\n* Embryo planned to be used for transfer generated from surgically obtained sperm due to a diagnosis of non-obstructive azoospermia\n* Recurrent\u002Fpersistent endometrial fluid in prior cycles","FEMALE","18 Years","45 Years",{"count":95,"type":96},62,"ESTIMATED","INTERVENTIONAL",[99],"NA","To determine the effectiveness of an intrauterine PRP infusion on endometrial thickness and in vitro fertilization (IVF) outcomes in a population of infertile women with a history of unresponsive thin endometrium.",[102],"Infertility of Uterine Origin","2026-06-01",{"date":105,"type":106},"2026-06-03","ACTUAL",{"date":108,"type":106},"2022-10-15",{"date":110,"type":96},"2027-12",{"name":5,"class":6},1]