Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2026-02-21 @ 6:49 PM
Study NCT ID:
NCT03062969
Status:
COMPLETED
Last Update Posted:
2017-02-24
First Post:
2017-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Transition From Blastomere to Trophectoderm Biopsy: Comparing Two PGS Strategies
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 383}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-20', 'studyFirstSubmitDate': '2017-02-16', 'studyFirstSubmitQcDate': '2017-02-20', 'lastUpdatePostDateStruct': {'date': '2017-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ongoing clinical pregnancy rate', 'timeFrame': '20 weeks after embryo transfer', 'description': 'Clinical pregnancy confirmed by ultrasound'}], 'secondaryOutcomes': [{'measure': 'Implantation Rate', 'timeFrame': '6 weeks after embryo transfer', 'description': 'Embryos implanted confirmed by ultrasound'}, {'measure': 'Number of available euploid blastocysts per cycle', 'timeFrame': 'Up to 15 days after embryo biopsy', 'description': 'Transferable or vitrified euploid blastocysts'}, {'measure': 'Miscarriage Rate', 'timeFrame': 'Until 20 weeks after embryo transfer'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Infertility', 'Preimplantation Genetic Screening']}, 'descriptionModule': {'briefSummary': 'Shortly after the implementation of Comprehensive Chromosome Screening (CCS) techniques for Preimplantation Genetic Screening (PGS) came the transition in biopsy timing. Trophectoderm biopsy is meant to overcome the limitations of cleavage stage biopsy and single cell analysis.', 'detailedDescription': 'The investigators have recently introduced this new approach and a frozen-thawed policy of euploid blastocysts is routinely performed.\n\nThis is a single centre retrospective study in patients undergoing a PGS cycle. The aim of the study is to assess the results obtained in a PGS programme after the implementation of a new biopsy timing and transfer policy. Results obtained in PGS cycles with blastocyst biopsy and frozen-thawed embryo transfer were analysed in comparison to cycles with cleavage stage biopsy and fresh blastocyst transfer.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing a PGS cycle with own gametes for any of the following indications: advanced maternal age, repeated implantation failure, recurrent miscarriages, severe male factor, and previous affected pregnancies.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Own gametes\n* PGS for: advanced maternal age, repeated implantation failure, recurrent miscarriages, severe male factor, and previous affected pregnancies\n\nExclusion Criteria:\n\n* PGS cycles with gamete donation\n* Altered karyotypes\n* Combined Preimplantation genetic diagnosis (PGD)+PGS cycles'}, 'identificationModule': {'nctId': 'NCT03062969', 'briefTitle': 'The Transition From Blastomere to Trophectoderm Biopsy: Comparing Two PGS Strategies', 'organization': {'class': 'OTHER', 'fullName': 'Fundacion Dexeus'}, 'officialTitle': 'The Transition From Blastomere to Trophectoderm Biopsy: Comparing Two PGS Strategies', 'orgStudyIdInfo': {'id': 'FDS-PGS-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cleavage stage biopsy group', 'description': 'Patients undergoing a PGS cycle with single blastomere biopsy on day 3 and analysis using comparative genomic hybridation bacterial artificial chromosome (BAC) arrays (aCGH) If euploid blastocysts were available, patients underwent fresh blastocyst transfer on day 5.', 'interventionNames': ['Procedure: Cleavage stage biopsy group']}, {'label': 'Trophectoderm biopsy group', 'description': 'Patients undergoing a PGS cycle with blastocyst biopsy on day 5-7 and analysis using comparative genomic hybridation bacterial artificial chromosome (BAC) arrays (aCGH). If euploid blastocysts were available, patients underwent frozen-thawed blastocyst transfer.', 'interventionNames': ['Procedure: Trophectoderm biopsy group']}], 'interventions': [{'name': 'Cleavage stage biopsy group', 'type': 'PROCEDURE', 'description': '* intracytoplasmatic sperm injection (ICSI)- (Invitro Fertilization)IVF\n* Time lapse embryo culture\n* Cleavage stage biopsy\n* aCGH analysis\n* Fresh euploid embryo transfer', 'armGroupLabels': ['Cleavage stage biopsy group']}, {'name': 'Trophectoderm biopsy group', 'type': 'PROCEDURE', 'description': '* ICSI-IVF\n* Time lapse embryo culture\n* Day 3 zona pellucida opening\n* Trophectoderm biopsy\n* aCGH analysis\n* Frozen-thawed euploid embryo transfer', 'armGroupLabels': ['Trophectoderm biopsy group']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundacion Dexeus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Lluc Coll Lujan', 'investigatorAffiliation': 'Fundacion Dexeus'}}}}