[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100588405":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":31,"centralContacts":37,"locations":43,"responsibleParty":65,"collaborators":10,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":69,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":10,"studyType":81,"phases":10,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":97,"whyStopped":10,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Igenomix","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Blastocysts from abnormally fertilized oocytes during assisted reproduction",null,"During the conventional ICSI\u002FIVF procedures in the laboratory, the embryologist observing fertilization will identify embryos with an abnormal pronuclear pattern and preselect them for the study. These embryos will be cultured in a time-lapse incubator following the laboratory's standard practice. All recorded morphokinetic parameters, along with the corresponding images, will be documented. Each embryo will be monitored, its developmental quality assessed and recorded to determine whether it reaches the blastocyst stage. If so, the researchers will contact the patient to ask consent for these embryos to be included in the study.\n\nEmbryos with an abnormal pronuclear pattern that fail to reach the blastocyst stage due to developmental blockage will be discarded.\n\nNo drugs or medical devices will be used.",[13,14,15],"Genetic: Parental samples","Diagnostic Test: PGT-A","Genetic: TE rebiopsies and spent blastocyst media collection",[17,22,27],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":10},"GENETIC","Parental samples","On fertilization, following the conventional ICSI\u002FIVF procedure, samples from cumulus cells (obtained during the routine oocyte denudation process) and surplus sperm cells present in seminal plasma will be retrieved. These samples will be stored frozen at -20°C until they are sent to Igenomix. There, they will be used to perform the genetic analysis required to achieve the study's objectives, provided the patient consents to participate. If the patient ultimately chooses not to participate, these samples will be destroyed.\n\nParents may be asked to provide a saliva sample for the same purpose in cases where obtaining the samples during fertilization was not possible or if the collected samples were unsuitable for processing in the laboratory. The saliva sample may be collected at the clinic during one of the scheduled visits for reproductive treatment or, alternatively, by the parents at home using a kit provided by the clinic.",[9],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":10},"DIAGNOSTIC_TEST","PGT-A","On day 3 of development, assisted hatching will be performed to facilitate biopsy at the blastocyst stage. Each embryo will be biopsied in the laboratory using conventional trophectoderm (TE) biopsy techniques on day +5, +6, or +7 of development, depending on when they reach the appropriate blastocyst stage. After biopsy, blastocyst will be vitrified following the clinical routine protocol and store until the genetic results are available. The biopsy samples will be placed in a PCR tube labeled with its corresponding study-specific code and stored in a cold rack at 4°C before being transferred to a freezer at -20°C. Finally, the samples will be sent to the Igenomix for preimplantation genetic testing for aneuploidy.",[9],{"type":18,"name":28,"description":29,"armGroupLabels":30,"otherNames":10},"TE rebiopsies and spent blastocyst media collection","After obtaining the PGT-A results, any embryo not genetically confirmed as euploid and without ploidy abnormalities will be thawed, washed, and cultured for rebiopsy. A complementary analysis using next-generation sequencing (NGS) techniques will be performed to confirm the diagnosis and determine the origin of the abnormalities. For this additional analysis, in addition to the new biopsies, the individual culture medium of each embryo will be aspirated after an incubation period of 8 to 24 hours. The collected medium will be placed in PCR tubes and stored in a freezer at -20°C before being sent to the laboratory.\n\nRegardless the result of these complementary analysis, no rebiopsied blastocyst will be considered for clinical purposes.",[9],[32,35],{"name":33,"affiliation":5,"role":34},"Pere Mir Pardo, PhD","PRINCIPAL_INVESTIGATOR",{"name":36,"affiliation":5,"role":34},"Carmen Rubio Lluesa, PhD",[38],{"name":39,"role":40,"phone":41,"phoneExt":10,"email":42},"Carlos A Gomez De La Cruz, BSc MSc","CONTACT","+34963905310","carlos.gomez@igenomix.com",[44],{"facility":45,"status":10,"city":46,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Equipo Médico Crespo Valencia","Valencia","46015","Spain","ES",{"type":51,"coordinates":52},"Point",[53,54],-0.37966,39.47391,{"lat":54,"lon":53},[57,61,63],{"name":58,"role":40,"phone":59,"phoneExt":10,"email":60},"Jose Teruel López, BSc MSc","+34 961 042 557","jteruel@juanacrespo.es",{"name":62,"role":34,"phone":10,"phoneExt":10,"email":10},"María Escribá Suarez, BSc MSc",{"name":64,"role":34,"phone":10,"phoneExt":10,"email":10},"Marina Benavent Martínez, BSc MSc",{"type":66,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100588405","study-of-abnormally-fertilized-embryos-100588405",false,"NCT06940973","Study of Abnormally Fertilized Embryos","Prospective Observational Study of the Morphokinetics and Ploidy of Blastocysts With Abnormal Fertilization (1PN, 2.1PN and 3PN) to Identify the Origin of Fertilization Alterations","SAFE","Inclusion Criteria:\n\n* ART patients who sign the Informed Consent of the study.\n* Age: oocytes from women ≤ 49 years and semen from men ≤ 60 years. Donation of gametes is allowed.\n* ≥1 blastocysts from oocytes with an abnormal pronuclear pattern (1PN, 2.1PN, and\u002For 3PN) and with the presence of 2 polar bodies (PB), cultured in a time-lapse incubator.\n\nExclusion Criteria:\n\n* No exclusion criteria have been considered for this study.","ALL","18 Years","49 Years",{"count":79,"type":80},300,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to determine the diploidy rate of haploid and triploid embryos from in vitro fertilization (IVF) cycles. The main questions it aims to answer are:\n\n* Can a molecular genetic fertilization check of abnormally fertilized embryos be used to expand opportunities for couples undergoing assisted reproduction treatment?\n* Is the chromosomal loss or gain present in abnormally fertilized embryos predominantly maternal in origin?\n\nFor this purpose, we will evaluate the morphokinetics and ploidy of about 300 embryos with different types of abnormal pronuclear patterns (1PN, 2.1PN, and 3PN) that reach the blastocyst stage. Whenever possible, embryos with a non-diploid chromosomal complement will also be assessed to determine the origin (maternal or paternal) of the chromosomal set that has been lost or gained.\n\nStudy subjects will follow their previously scheduIed IVF\u002FICSI treatment and no additional visits\u002Finterventions will be required for participating.",[84],"Infertility (IVF Patients)",[24,86,87,88,89,90,91,92,93,94,95,96],"niPGT-A","Blastocyst","Infertility","In vitro fertilization","Ploidy","Embryo development","Time-lapse culture","Triploid","Haploid","Abnormal fertilization","Pronuclei","NOT_YET_RECRUITING","2025-04-16",{"date":100,"type":101},"2025-04-23","ACTUAL",{"date":103,"type":80},"2025-04",{"date":105,"type":80},"2026-09",{"name":5,"class":6},1]