Ignite Creation Date:
2025-12-26 @ 10:36 AM
Ignite Modification Date:
2025-12-31 @ 10:22 PM
Study NCT ID:
NCT05364528
Status:
COMPLETED
Last Update Posted:
2022-05-24
First Post:
2022-05-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pregnancy Rate in Direct Versus Afterload Technique of Embryo Transfer
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': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8127}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-17', 'studyFirstSubmitDate': '2022-05-03', 'studyFirstSubmitQcDate': '2022-05-03', 'lastUpdatePostDateStruct': {'date': '2022-05-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'clinical pregnancy rate', 'timeFrame': '6 years', 'description': 'number of pregnancies diagnosed by ultrasonographic visualization of one or more gestational sacs x 100 divided by the number of embryo transfer cycles'}], 'secondaryOutcomes': [{'measure': 'difficult transfer rate', 'timeFrame': '6 years', 'description': 'advancement of the outer sheath, multiple attempts, force, required manipulation, use of a stylet or tenaculum, dilatation, use of a different catheter'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fertility Issues', 'IVF', 'Embryo Transfer']}, 'referencesModule': {'references': [{'pmid': '37819552', 'type': 'DERIVED', 'citation': 'Cirillo F, Immediata V, Ronchetti C, Carletti T, Morenghi E, Albani E, Baggiani A, Levi-Setti PE. Steps forward in embryo transfer technique: a retrospective study comparing direct versus afterload catheters at different time frames. J Assist Reprod Genet. 2023 Dec;40(12):2895-2902. doi: 10.1007/s10815-023-02957-y. Epub 2023 Oct 11.'}]}, 'descriptionModule': {'briefSummary': 'The primary outcome of the study is to determine if a difference in terms of pregnancy rate exists between direct and afterload embryo transfer (ET) techniques.\n\nThe secondary end points include the evaluation of the difficult transfer rates.', 'detailedDescription': 'The study database includes all the single fresh and frozen (G5-G6) blastocyst transfers performed at Humanitas Fertility Centre between 1st January 2016 and 31th December 2021 by using the direct and afterload protocols.\n\nAny blastocysts that underwent preimplantation genetic testing will be excluded from the analysis, as well as embryos derived from gamete donation or those imported from other centers.\n\nData are gathered using a specific internal web-based database, which allows to organize, store and readily retrieve information about patients and IVF cycle.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '43 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study database includes all the single fresh and frozen (G5-G6) blastocyst transfers performed at Humanitas Fertility Centre between 1st January 2016 and 31th December 2021 by using the direct and afterload protocols.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* IVF procedure\n* Fresh and frozen single blastocyst transfer\n\nExclusion Criteria:\n\n* Any blastocysts that underwent PGS testing\n* Embryos derived from gamete donation\n* Embryos imported from other centers'}, 'identificationModule': {'nctId': 'NCT05364528', 'briefTitle': 'Pregnancy Rate in Direct Versus Afterload Technique of Embryo Transfer', 'organization': {'class': 'OTHER', 'fullName': 'Istituto Clinico Humanitas'}, 'officialTitle': 'Pregnancy Rate in Single Step Versus After Load Technique of Embryo Transfer: a Retrospective Analysis', 'orgStudyIdInfo': {'id': '12022'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'clinical pregnancies with direct catheter', 'description': 'Clinical pregnancies occurred after fresh and frozen blastocyst transfers using direct technique.'}, {'label': 'clinical pregnancies with afterload catheter', 'description': 'Clinical pregnancies occurred after fresh and frozen blastocyst transfers using afterload technique.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituto Clinico Humanitas', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}