Ignite Creation Date:
2025-12-26 @ 5:23 PM
Ignite Modification Date:
2025-12-29 @ 5:56 AM
Study NCT ID:
NCT04485806
Status:
COMPLETED
Last Update Posted:
2020-07-24
First Post:
2020-07-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Culture Media Microdroplet Geometry With Different Oil Overlay and Its Effect on Embryonic Development.
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', 'interventionModelDescription': 'Effect of two different culture dishes with two different oil overlay which used in human embryos culturing through ICSI procedures on the pre implantaion embryonic development.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-01-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-22', 'studyFirstSubmitDate': '2020-07-22', 'studyFirstSubmitQcDate': '2020-07-22', 'lastUpdatePostDateStruct': {'date': '2020-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blastulation rate', 'timeFrame': '5-6 days after ICSI', 'description': 'Percentage of total blastocysts / Total cleaved embryos'}, {'measure': 'High quality blast rate', 'timeFrame': '5-6 days after ICSI', 'description': "Morphological grading of trophectoderm and Inner cell mass using Gardner's criteria 1999, from grade A and B ( A is the highest quality). Total high grade embryos/ total blast embryos."}], 'secondaryOutcomes': [{'measure': 'Fertilization rate', 'timeFrame': '16-19 hours of ICSI', 'description': 'Percentage of fertilized oocyte (appearance of two pronuclei) / Number of injected oocytes'}, {'measure': 'Cleavage rate', 'timeFrame': '72 hours of ICSI', 'description': 'Percentage of cleaved embryos/ total number of fertilized oocytes'}, {'measure': 'High quality D3 embryos', 'timeFrame': '72 hours of ICSI', 'description': "High quality D3 embryos according to Gardner's criteria / total cleaved embryos"}, {'measure': 'Good quality trophectoderm/inner cell mass', 'timeFrame': '5-6 days after ICSI', 'description': "better grade than 3BB of blast embryos according to Gardner's criteria 1999"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['dry incubator', 'Osmolality', 'Oil overlay', 'Microdrops'], 'conditions': ['Embryonic Development', 'Infertility']}, 'descriptionModule': {'briefSummary': 'A prospective randomized study included 1695 MII sibling oocytes collected from 100 patients undergoing ICSI.', 'detailedDescription': 'Purpose:\n\nto determine the effect of culture media microdroplet geometry of different culture dishes and oil overlay on the pre implantation embryo development in dry incubators\n\nMethod:\n\nWe used sibling oocytes splits between two different dishes : GPS (life global, USA) and SPL (life science, Korea) with two different oils : light mineral oil (LM)(Irvine, USA) and paraffin oil (PO)(Vitro life, Sweden). All embryos cultured in dry incubators at the same conditions.\n\nstatistical analysis done using SPSS version 23'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '37 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female age is ≤ 37 years old with ≥ 8 MII oocytes\n* Males with normal semen parameters (WHO 2010).\n* We conducted three experiments all with Siblings oocytes splits and all embryos\n\nExclusion Criteria:\n\n* Oocyte or sperm donation.\n* Sever male factor.\n* Any contradictions to undergoing in vitro fertilization or goandotropin stimulation.'}, 'identificationModule': {'nctId': 'NCT04485806', 'briefTitle': 'Culture Media Microdroplet Geometry With Different Oil Overlay and Its Effect on Embryonic Development.', 'organization': {'class': 'OTHER', 'fullName': 'Ganin Fertility Center'}, 'officialTitle': 'The Effect of Culture Media Microdroplet Geometry and Different Oil Overlay on Pre Implantation Embryonic Development in Dry Incubators: Prospective Randomized Study.', 'orgStudyIdInfo': {'id': 'MH0002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'GPS / LM versus SPL/LM', 'description': 'to determine the effect of micro droplet geometry in 3D dishes (GPS) or 2D dishes (SPL) in combination with light mineral oil (LM).', 'interventionNames': ['Other: GPS/LM', 'Other: SPL/LM']}, {'type': 'OTHER', 'label': 'GPS/PO versus SPL/PO', 'description': 'to determine the effect of micro droplet geometry in 3D dishes (GPS) or 2D dishes (SPL) in combination with paraffin oil (PO).', 'interventionNames': ['Other: GPS/PO', 'Other: SPL/PO']}, {'type': 'OTHER', 'label': 'GPS/PO versus GPS/LM', 'description': 'to determine the effect of oil overlay light mineral(LM) or paraffin oil (PO) in combination with paraffin oil 3D dishes (GPS).', 'interventionNames': ['Other: GPS/LM', 'Other: GPS/PO']}, {'type': 'OTHER', 'label': 'SPL/PO versus SPL/LM', 'description': 'to determine the effect of oil overlay light mineral(LM) or paraffin oil (PO) in combination with paraffin oil 2D dishes (SPL).', 'interventionNames': ['Other: SPL/LM', 'Other: SPL/PO']}], 'interventions': [{'name': 'GPS/LM', 'type': 'OTHER', 'description': 'Media microdroplet geometry (3D dishes) in combination with light mineral oil overlay', 'armGroupLabels': ['GPS / LM versus SPL/LM', 'GPS/PO versus GPS/LM']}, {'name': 'SPL/LM', 'type': 'OTHER', 'description': 'Media microdroplet geometry (2D dishes) in combination with light mineral oil overlay', 'armGroupLabels': ['GPS / LM versus SPL/LM', 'SPL/PO versus SPL/LM']}, {'name': 'GPS/PO', 'type': 'OTHER', 'description': 'Media microdroplet geometry (3D dishes) in combination with Paraffin oil overlay', 'armGroupLabels': ['GPS/PO versus GPS/LM', 'GPS/PO versus SPL/PO']}, {'name': 'SPL/PO', 'type': 'OTHER', 'description': 'Media microdroplet geometry (2D dishes) in combination with paraffin oil overlay', 'armGroupLabels': ['GPS/PO versus SPL/PO', 'SPL/PO versus SPL/LM']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11728', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Ganin Fertility Center', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Manar M Hozyen, MSc.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ganin Fertility Center'}, {'name': 'Amr Elshimy, BSc.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ganin Fertility Center'}, {'name': 'Hanaa Elkhader, BSc.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ganin Fertility Center'}, {'name': 'Hosam Zaki, MSc.', 'role': 'STUDY_CHAIR', 'affiliation': 'Ganin Fertility Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ganin Fertility Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}