Ignite Creation Date:
2025-12-26 @ 10:59 AM
Ignite Modification Date:
2025-12-31 @ 11:41 AM
Study NCT ID:
NCT01774006
Status:
COMPLETED
Last Update Posted:
2015-09-02
First Post:
2013-01-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Individual Culture and Group Culture of Preimplantation Embryos in Human IVF Treatments
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 532}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-01', 'studyFirstSubmitDate': '2013-01-18', 'studyFirstSubmitQcDate': '2013-01-18', 'lastUpdatePostDateStruct': {'date': '2015-09-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Time needed for evaluation of zygotes and embryos', 'timeFrame': '18, 24, 36 and 72 hours after fertilization'}], 'primaryOutcomes': [{'measure': 'Clinical pregnancy rate', 'timeFrame': '4 weeks after the embryo transfer', 'description': 'Number of clinical pregnancies (/No. of embryo transfers)'}, {'measure': 'Implantation rate', 'timeFrame': '4 weeks after embryo transfer', 'description': 'Number of embryos implanted (/number of embryos transferred)'}], 'secondaryOutcomes': [{'measure': 'Fertilization rate', 'timeFrame': '18 hours after sperm injection', 'description': 'Number of oocytes fertilized. (only in intracytoplasmic sperm injection cycles)'}, {'measure': 'Embryo quality', 'timeFrame': '36 and 72 hours after fertilization', 'description': 'Number and quality of blastomeres, amount of fragmentation embryo grade'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['In vitro fertilization', 'Embryo transfer', 'Embryo culture', 'individual culture', 'Group culture', 'embryo quality', 'Pregnancy rate', 'Implantation'], 'conditions': ['Other Complications Associated With Artificial Fertilization']}, 'referencesModule': {'references': [{'pmid': '35278201', 'type': 'DERIVED', 'citation': 'Fancsovits P, Pribenszky C, Lehner A, Murber A, Kaszas Z, Nemes A, Urbancsek J. Prospective-randomized study comparing clinical outcomes of IVF treatments where embryos were cultured individually or in a microwell group culture dish. Biol Futur. 2022 Jun;73(2):229-236. doi: 10.1007/s42977-022-00113-8. Epub 2022 Mar 12.'}]}, 'descriptionModule': {'briefSummary': 'Prospective randomized comparison of two widely used in vitro culture system in human IVF treatments. In vitro fertilized oocytes and embryos are cultured in individual culture media droplets using conventional petridish or in group culture using WOW (well of the well) petridish.\n\nPrimary outcome: implantation and pregnancy rates Secondary outcome: fertilization rate and embryo quality'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients entering in vitro fertilization and embryo transfer treatment', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infertile patients entering in vitro fertilization treatment\n* at least 1 oocyte collected\n\nExclusion Criteria:\n\n* no oocytes collected'}, 'identificationModule': {'nctId': 'NCT01774006', 'acronym': 'GroupCulture', 'briefTitle': 'Comparison of Individual Culture and Group Culture of Preimplantation Embryos in Human IVF Treatments', 'organization': {'class': 'OTHER', 'fullName': 'Semmelweis University'}, 'officialTitle': 'Comparison of Individual Culture and Group Culture of Preimplantation Embryos in Human IVF Treatments', 'orgStudyIdInfo': {'id': 'SemmelweisU-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group culture', 'description': 'Embryos cultured in groups of 2-10', 'interventionNames': ['Other: individual embryo culture or group culture']}, {'label': 'Individual culture', 'description': 'Embryos cultured individually', 'interventionNames': ['Other: individual embryo culture or group culture']}], 'interventions': [{'name': 'individual embryo culture or group culture', 'type': 'OTHER', 'description': 'Embryos cultured in a 25 microliter droplet of culture media individually in a conventional petridish or in groups of 2-10 embryos in a Well-of-the-Well petridish', 'armGroupLabels': ['Group culture', 'Individual culture']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1088', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Semmelweis University First Department of Obstetrics and Gynecology', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}], 'overallOfficials': [{'name': 'Janos Urbancsek, DSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Semmelweis University First Department of Obstetrics and Gynecology'}, {'name': 'Peter Fancsovits, Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Semmelweis University First Department of Obstetrics and Gynecology'}, {'name': 'Csaba Pribenszky, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Veterinary Sciences, Budapest'}, {'name': 'Adam Lehner, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Semmelweis University First Department of Obstetrics and Gynecology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Semmelweis University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Clinical Embryologyst', 'investigatorFullName': 'Peter Fancsovits, Ph.D.', 'investigatorAffiliation': 'Semmelweis University'}}}}