[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100556403":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":27,"locations":36,"responsibleParty":162,"collaborators":10,"id":164,"slug":165,"hasResults":166,"nctId":167,"briefTitle":168,"officialTitle":169,"acronym":170,"eligibilityCriteria":171,"healthyVolunteers":166,"sex":172,"minAge":173,"maxAge":174,"enrollmentInfo":175,"targetDuration":10,"studyType":178,"phases":10,"briefSummary":179,"conditions":180,"keywords":182,"overallStatus":39,"whyStopped":10,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":193,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":201},{"fullName":5,"class":6},"Igenomix","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Infertile women with medical recommendation of niPGT-A",null,"Patients will not undergo any additional intervention apart from those already scheduled for their ART. The only study specific procedures are the culture of the embryos in a timelapse system and the collection of the embryo's culture media, which is usually discarded. Both procedures will be performed following the stardard practice.\n\nNo drugs will be administered as per the study.",[13],"Diagnostic Test: niPGT-A",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DIAGNOSTIC_TEST","niPGT-A","Embryos will be cultured, from oocyte fertilization up to day 6\u002F7 of development, in a time lapse system following the standard practice. On day 6\u002F7, embryos will be vitrified and the embryos's media will be collected for niPGT-A analysis.\n\nPatients will undergo a single embryo transfer (SET) following the niPGT-A report indications. In the event of 1 or more embryos with the same niPGT-A score, the embryo for transfer will be determined by the site standard practice (morphology or time-lapse score).\n\nPatients who do not achieve a pregnancy after a niPGT-A guided SET can undergo as many niPGT-A guided SET or COS+niPGT-A cycles as they need to get pregnant, while the study recruitment phase is active.",[9],[21,24],{"name":22,"affiliation":5,"role":23},"Luis Navarro, PhD","PRINCIPAL_INVESTIGATOR",{"name":25,"affiliation":5,"role":26},"Carmen Rubio, PhD","STUDY_CHAIR",[28,33],{"name":29,"role":30,"phone":31,"phoneExt":10,"email":32},"Carlos Gomez, BSc MSc","CONTACT","+34963905310","carlos.gomez@igenomix.com",{"name":34,"role":30,"phone":10,"phoneExt":10,"email":35},"Ianae Ceschin, MSc","embrace@igenomix.com",[37,55,71,85,102,118,133,147],{"facility":38,"status":39,"city":40,"state":10,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Kinderwunsch Institut Schenk","RECRUITING","Dobl","A-8143","Austria","AT",{"type":45,"coordinates":46},"Point",[47,48],13.25685,48.12935,{"lat":48,"lon":47},[51],{"name":52,"role":30,"phone":53,"phoneExt":10,"email":54},"Michael Schenk, MD","+43 (0) 3136 55 111","Michael.Schenk@kinderwunsch-institut.at",{"facility":56,"status":39,"city":57,"state":57,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":65,"contacts":66},"Fertty","Barcelona","08010","Spain","ES",{"type":45,"coordinates":62},[63,64],2.15899,41.38879,{"lat":64,"lon":63},[67],{"name":68,"role":30,"phone":69,"phoneExt":10,"email":70},"Mariona Rius","+34 937378190","mariona.rius@fertty.com",{"facility":72,"status":39,"city":73,"state":73,"zip":74,"country":59,"countryCode":60,"cosmosGeoPoint":75,"geoPoint":79,"contacts":80},"Hospital Ruber Internacional","Madrid","28034",{"type":45,"coordinates":76},[77,78],-3.70256,40.4165,{"lat":78,"lon":77},[81],{"name":82,"role":30,"phone":83,"phoneExt":10,"email":84},"Jesus Maria R Franco","+34913875000","jesusm.franco@ruberinternacional.es",{"facility":86,"status":39,"city":87,"state":87,"zip":88,"country":59,"countryCode":60,"cosmosGeoPoint":89,"geoPoint":93,"contacts":94},"Next Fertility Murcia","Murcia","30007",{"type":45,"coordinates":90},[91,92],-1.13004,37.98704,{"lat":92,"lon":91},[95,99],{"name":96,"role":30,"phone":97,"phoneExt":10,"email":98},"Paloma Piqueras","+34 968 90 19 03","paloma.piqueras@next-clinics.com",{"name":100,"role":30,"phone":10,"phoneExt":10,"email":101},"Emilio Gomez","emilio.gomez@nextfertility.es",{"facility":103,"status":39,"city":104,"state":105,"zip":106,"country":59,"countryCode":60,"cosmosGeoPoint":107,"geoPoint":111,"contacts":112},"Next Fertility Sevilla","Seville","Sevilla","41012",{"type":45,"coordinates":108},[109,110],-5.97317,37.38283,{"lat":110,"lon":109},[113,115],{"name":96,"role":30,"phone":114,"phoneExt":10,"email":98},"+34 954 45 61 69",{"name":116,"role":30,"phone":10,"phoneExt":10,"email":117},"Rocio Diaz","rocio.diaz@nextfertility.es",{"facility":119,"status":39,"city":120,"state":120,"zip":121,"country":59,"countryCode":60,"cosmosGeoPoint":122,"geoPoint":126,"contacts":127},"Next Fertility Valencia","Valencia","46009",{"type":45,"coordinates":123},[124,125],-0.37966,39.47391,{"lat":125,"lon":124},[128,130],{"name":96,"role":30,"phone":129,"phoneExt":10,"email":98},"+34 963 16 02 40",{"name":131,"role":30,"phone":10,"phoneExt":10,"email":132},"Vicente Llosa","vicente.llosa@nextfertility.es",{"facility":134,"status":39,"city":104,"state":10,"zip":135,"country":59,"countryCode":60,"cosmosGeoPoint":136,"geoPoint":138,"contacts":139},"Vida Recoletas Sevilla","41092",{"type":45,"coordinates":137},[109,110],{"lat":110,"lon":109},[140,144],{"name":141,"role":30,"phone":142,"phoneExt":10,"email":143},"Manuel Fernandez, MD","+34 954286274","manuel.fernandez@gruporecoletas.com",{"name":145,"role":30,"phone":10,"phoneExt":10,"email":146},"Nicolas Prados","nicolas.prados@gruporecoletas.com",{"facility":148,"status":39,"city":149,"state":10,"zip":10,"country":150,"countryCode":151,"cosmosGeoPoint":152,"geoPoint":156,"contacts":157},"Orchid IVF Clinic","Dubai","United Arab Emirates","AE",{"type":45,"coordinates":153},[154,155],55.30927,25.07725,{"lat":155,"lon":154},[158],{"name":159,"role":30,"phone":160,"phoneExt":10,"email":161},"Maria Banti","+971 4 427 2852","maria.b@orchid-fertility.com",{"type":163,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100556403","international-pilot-study-for-dual-non-invasive-assesment-of-embryo-development-100556403",false,"NCT06524648","International Pilot Study for Dual Non-invasive Assesment of Embryo Development","A Prospective, Multicenter, Observational Pilot Study to Evaluate the Combination of niPGT-A and Morphokinetics for the Non-invasive Assessment of Embryo Development","PANDORA","Inclusion Criteria:\n\n* Study ICF signature.\n* Female age between 20 and 42 years (bot included).\n* IVF, ICSI or IVF\u002FICSI performed in fresh own or donated oocytes. Note: donor sperm is allowed.\n* niPGT-A cases with a deferred SET (of a day 6\u002F7 vitrified blastocyst) for any medical indication.\n* Embryos cultured individually in a TL system from day 0\u002F1 to day 6\u002F7.\n\nExclusion Criteria:\n\n* Embryos with abnormal fertilization (different from 2PN). (Note: In case of no 2PN embryos, patients may repeat the COS cycle).\n* Female\u002Fcouple with PGT-M and\u002For PGT-SR indication.\n* Assisted hatching and\u002For artificial collapse before media collection.\n* Known abnormal karyotype.\n* Pathologies or malformations affecting the uterine cavity (polyps, intramural myomas ≥ 4cm or submucosal, septum or hydrosalpinx) during the patient's participation. (Note: patients are allowed to participate if the pathology is previously operated at least 3 months before patient enrollment).\n* Any illness or medical condition that is unstable or which, according to medical criteria, may put at risk the patient's safety and her compliance in the study.","FEMALE","20 Years","42 Years",{"count":176,"type":177},200,"ESTIMATED","OBSERVATIONAL","Choosing the best embryo is one of the major challenges for achieving success in in vitro fertilization (IVF). Traditionally, embryo evaluation has been based on morphological quality (how the embryo looks like) and chromosomal status as diagnosed by a genetic testing. However, recently new techniques that do not require manipulation of the embryo have been developed and have shown promising results.\n\nThe goal of this observational study is, by combining two non-invasive techniques, to find out some parameters during embryo development which may be related with the embryo's chromosomic status. For that, infertile women planning to undergo an IVF\u002FICSI treatment with a recommended niPGT-A (non-invasive Preimplantation Genetic Testing for Aneuploidies) will be invited to join the study. The main question it aims to answer is:\n\n* Can morphokinetics parameters correlate with embryo chromosomal status?\n\nParticipants will follow their previously programmed IVF\u002FICSI treatment and no additional visits\u002Finterventions will be required by their participation in the study. The obtained embryos will be cultured in a time-lapse system instead of in a conventional incubator, and niPGT-A will be performed. Following the standard practice, a deferred single embryo transfer (SET) will be performed according to the niPGT-A results. After the transfer, patients will be followed-up as usual.",[181],"Infertility",[181,183,184,17,185,186,187,188,189,190,191],"In vitro fertilization","Time lapse","Embryo Development","Embryonic cell-free DNA","Morphokinetics","Artificial Intelligence","Embryo selection","Blastocyst","Ongoing pregnancy rate","2025-07-29",{"date":194,"type":195},"2025-08-01","ACTUAL",{"date":197,"type":195},"2024-10-29",{"date":199,"type":177},"2027-01",{"name":5,"class":6},8]