Ignite Creation Date:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2026-03-06 @ 9:38 PM
Study NCT ID:
NCT02718105
Status:
COMPLETED
Last Update Posted:
2022-08-11
First Post:
2016-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Maternal and Fetal Compatibility in Assisted Reproductive Technology (ART)-Oocyte Donor Influences Live Birth Rate
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007246', 'term': 'Infertility'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Genomic DNA will be obtained and will be studied in Professor Moffet laboratory in Cambridge (department of Pathologí, University of Cambridge) KIR typing including copi number and HLA-C loci will be performed as previously described (Hiby 2010, Jiang 2012). KIR haplotype regions will be defined by the presence of the following KIR genes: Cen-A/2DL3; Tel-A/3DL1 and 2DS4; Cen-B/2DL2 and 2DS2; Tel-B/2DS1 and 3DS1. The HLA-C ligands for KIRs will be divided into 2 groups: HLA-C1 and HLA-C2.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-09', 'studyFirstSubmitDate': '2016-03-11', 'studyFirstSubmitQcDate': '2016-03-22', 'lastUpdatePostDateStruct': {'date': '2022-08-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compatibility maternal fetal KIR HLA-C', 'timeFrame': '2 years', 'description': 'KIR haplotype regions will be defined by the presence of the following KIR genes: Cen-A/2DL3: Tel-A/3DL1 and 2DS4; Cen-B/2DL2 and 2DS2; Tel-B/2DS1 and 3DS1. The HLA-C ligands for KIRs will be divided into 2 groups: HLA-C1 and HLA\\_C2'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['KIR HLA-C', 'ART'], 'conditions': ['Infertility']}, 'descriptionModule': {'briefSummary': 'Has the maternal KIR haplotype an impact in pregnancy, miscarriage and live birth rates per embryo transfer in donor oocytes -ART by paternal and oocyte donor HLA-C?', 'detailedDescription': 'The combination of maternal KIR haplotype and parental, donors HLA-C, could predict which couple can benefit for the selection of single embryo transfer (SET)/double embryo transfer (DET), or donor selection by HLA-C in ART, in order to increase the live birth rate (LBR)/cycle since HLA-C1/C1 donors are predicted to be safer and C2/C2 males or oocyte donors may be mor "dangerous" as identified by epidemiological studies'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing an assisted reproductive treatment', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI between 19 - 27 kg/m2\n* Blastocyst embryo transfer previous.\n* Normal karyotype, thrombophylic and immunological results.\n* Normal clinical history, viral serology, hormonal analysis (TSH, T4, prolactin, estrogen, progesterone), spermiogram, sperm FISH and pelvic ultrasound results.\n\nExclusion Criteria:\n\n* Pregnancy women.\n* Psychiatric disorders.\n* Uterus alterations.\n* Polycystic ovary syndrome\n* Genetic and autoimmune diseases.\n* Infectious diseases.\n* Corticoid and immunosuppressant treatments previous.'}, 'identificationModule': {'nctId': 'NCT02718105', 'briefTitle': 'Maternal and Fetal Compatibility in Assisted Reproductive Technology (ART)-Oocyte Donor Influences Live Birth Rate', 'organization': {'class': 'OTHER', 'fullName': 'IVI Madrid'}, 'officialTitle': 'Maternal Killer Cell Immunoglobulin-like Receptors (KIR) and Fetal (Human Leukocyte Antigen) HLA-C Compatibility in ART-oocyte Donor Influences Live Birth Rate a Prospective Controlled Cohort Study', 'orgStudyIdInfo': {'id': '1512-MAD-067-JG'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Receiver patients in donor oocyte -ART', 'description': 'Maternal and fetal compatibility KIR HLA-C determinations in ART -oocyte donor', 'interventionNames': ['Genetic: KIR HLAC determinations']}], 'interventions': [{'name': 'KIR HLAC determinations', 'type': 'GENETIC', 'description': 'We will take blood samples for KIR HLA-C determinations.', 'armGroupLabels': ['Receiver patients in donor oocyte -ART']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28035', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Instituto Valenciano de Infertilidad', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Juan Antonio Garcia Velasco, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IVI Madrid'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IVI Madrid', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Juan A Garcia-Velasco', 'investigatorAffiliation': 'IVI Madrid'}}}}