Ignite Creation Date:
2025-12-24 @ 9:22 PM
Ignite Modification Date:
2026-02-20 @ 8:09 PM
Study NCT ID:
NCT01950104
Status:
WITHDRAWN
Last Update Posted:
2020-03-06
First Post:
2013-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Day 3 Embryo Biopsy Versus Blastocyst Biopsy in PGS Cases
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'No started, lack of funding', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-05', 'studyFirstSubmitDate': '2013-09-23', 'studyFirstSubmitQcDate': '2013-09-23', 'lastUpdatePostDateStruct': {'date': '2020-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-09-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Live birth rate', 'timeFrame': '20 months'}], 'secondaryOutcomes': [{'measure': 'Fertilization rate', 'timeFrame': '1 year'}, {'measure': 'Embryo quality', 'timeFrame': '1 year', 'description': 'Day 3 embryo quality'}, {'measure': 'Implantation rate', 'timeFrame': '1 year'}, {'measure': 'Pregnancy rate', 'timeFrame': '20 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Embryo biopsy', 'Blastocyst stage', 'Day 3', 'Preimplantation genetic screening'], 'conditions': ['Infertility', 'Embryo Biopsy']}, 'descriptionModule': {'briefSummary': 'Preimplantation genetic diagnosis (PGS) is a technique that allow us to improve the results of assisted reproduction techniques through the selection of embryos free of chromosomal abnormalities.\n\nAt present, it has not been proved that the usage of PGS really improves the live birth rate in IVF cycles. However, it has been stated that the reason of not having better results when using PGS is that the methodology applied is not adequate.\n\nSeveral authors propose that the optimal methodology for PGS includes the application of comparative genomic hybridization (CGH) arrays for genetic testing and carrying out embryo biopsy at the blastocyst stage. Nevertheless, most IVF centres still applies the day 3 embryo biopsy as a daily routine. Despite this fact, there is a gradual transition towards the usage of blastocyst-stage biopsy instead of day 3 biopsy.\n\nThe purpose of this clinical study is analysing the results of the IVF cycles with embryo biopsy for PGS. Live birth rates and other parameters as the pregnancy and implantation rates together with embryo quality will be analysed and compared between two groups of patients undergoing IVF cycles with PGS. In one group the biopsy will be applied in day 3 of the embryo development, while in the other group the embryo biopsy will be fulfilled at the blastocyst stage.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients under 49 years undergoing IVF cycles with PGS for one of the following reasons:\n\n* Advanced maternal age\n* Recurrent implantation failure\n* Recurrent abortion\n* Severe male-factor infertility\n\nExclusion Criteria:\n\n* Not being able to sign the informed consent to participate in the study\n* Patients undergoing preimplantation genetic diagnosis'}, 'identificationModule': {'nctId': 'NCT01950104', 'acronym': 'VINCI', 'briefTitle': 'Day 3 Embryo Biopsy Versus Blastocyst Biopsy in PGS Cases', 'organization': {'class': 'OTHER', 'fullName': 'Vida Recoletas Sevilla'}, 'officialTitle': 'Comparative Study Between Day 3 Embryo Biopsy and Blastocyst Biopsy in Preimplantation Genetic Screening Cases', 'orgStudyIdInfo': {'id': 'IVISEV-005VINCI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Day 3 embryo biopsy', 'description': 'Embryo biopsy is applied at day 3 of the embryo development', 'interventionNames': ['Other: Day 3 embryo biopsy']}, {'type': 'EXPERIMENTAL', 'label': 'Blastocyst biopsy', 'description': 'Embryo biopsy is applied at the blastocyst stage of the embryo development (day 5 or 6)', 'interventionNames': ['Other: Blastocyst biopsy']}], 'interventions': [{'name': 'Day 3 embryo biopsy', 'type': 'OTHER', 'description': 'Embryo biopsy is applied at day 3 of the embryo development.', 'armGroupLabels': ['Day 3 embryo biopsy']}, {'name': 'Blastocyst biopsy', 'type': 'OTHER', 'description': 'Embryo biopsy is applied at the blastocyst stage of the embryo development', 'armGroupLabels': ['Blastocyst biopsy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41006', 'city': 'Seville', 'country': 'Spain', 'facility': 'IVI Sevilla', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vida Recoletas Sevilla', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}