Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2025-12-27 @ 12:27 AM
Study NCT ID:
NCT05448859
Status:
COMPLETED
Last Update Posted:
2022-07-08
First Post:
2022-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Oocyte Denudation Time and Intracytoplasmic Sperm Injection Time on Embryo Quality
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020554', 'term': 'Sperm Injections, Intracytoplasmic'}], 'ancestors': [{'id': 'D005307', 'term': 'Fertilization in Vitro'}, {'id': 'D027724', 'term': 'Reproductive Techniques, Assisted'}, {'id': 'D012099', 'term': 'Reproductive Techniques'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-03', 'studyFirstSubmitDate': '2022-06-20', 'studyFirstSubmitQcDate': '2022-07-03', 'lastUpdatePostDateStruct': {'date': '2022-07-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oocyte denudation time', 'timeFrame': '3 hours', 'description': 'time measured for oocyte denudation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['infertility', 'assisted reproductive technology', 'embryo quality', 'oocyte denudation', 'intracytoplasmic sperm injection'], 'conditions': ['Fertility Disorders']}, 'referencesModule': {'references': [{'pmid': '15169586', 'type': 'RESULT', 'citation': 'Isiklar A, Mercan R, Balaban B, Alatas C, Aksoy S, Urman B. Impact of oocyte pre-incubation time on fertilization, embryo quality and pregnancy rate after intracytoplasmic sperm injection. Reprod Biomed Online. 2004 Jun;8(6):682-6. doi: 10.1016/s1472-6483(10)61649-5.'}]}, 'descriptionModule': {'briefSummary': 'An observational analytic retrospective study was conduct using cross-sectional study. The subject were oocytes from in-vitro fertilization procedures using the ICSI method at the assisted reproductive technology clinic in a private hospital in Bandung for the period 2017 - 2019. Three variables were oocyte denudation time, ICSI time and embryo quality collected from samples that met the research criteria.', 'detailedDescription': 'This study analyses the different oocyte denudation time after ICSI on all embryos generated during IVF procedures between 1 Januaryr 2017 and 31 December 2019. All oocytes arer categorised on how many hours their denudation times were and these were then assessed for their qualities.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Hours', 'minimumAge': '3 Hours', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Oocytes are derived from patients enrolled in IVF', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* oocytes collected from in-vitro fertilisation procedures involving intracytoplasmic sperm injection\n\nExclusion Criteria:\n\n* oocytes from patients \\>40 years old\n* oocytes from primary infertility \\>5 years\n* endometriosis\n* polycystic ovarian syndrome'}, 'identificationModule': {'nctId': 'NCT05448859', 'briefTitle': 'Effect of Oocyte Denudation Time and Intracytoplasmic Sperm Injection Time on Embryo Quality', 'organization': {'class': 'OTHER', 'fullName': 'Universitas Padjadjaran'}, 'officialTitle': 'The Effect of Oocyte Denudation Time and Intracytoplasmic Sperm Injection Time on Embryo Quality at Assisted Reproductive Technology Clinic', 'orgStudyIdInfo': {'id': 'OBGY-202206.02'}}, 'armsInterventionsModule': {'armGroups': [{'label': '3-4 hours denudation', 'description': 'oocytes with 3-4 hours denudation time', 'interventionNames': ['Procedure: intracytoplasmic sperm injection']}, {'label': '4-5 hours denudation', 'description': 'oocytes with 4-5 hours denudation time', 'interventionNames': ['Procedure: intracytoplasmic sperm injection']}, {'label': '5-6 hours denudation time', 'description': 'oocytes with 5-6 hours denudation time', 'interventionNames': ['Procedure: intracytoplasmic sperm injection']}, {'label': '6-7 hours denudation time', 'description': 'oocytes with 6-7 hours denudation time', 'interventionNames': ['Procedure: intracytoplasmic sperm injection']}, {'label': 'more than 7 hours denudation time', 'description': 'oocytes with more than 7 hours denudation time', 'interventionNames': ['Procedure: intracytoplasmic sperm injection']}], 'interventions': [{'name': 'intracytoplasmic sperm injection', 'type': 'PROCEDURE', 'otherNames': ['ICSI'], 'description': 'injection of sperm into an oocyte in assisted reproductive technology', 'armGroupLabels': ['3-4 hours denudation', '4-5 hours denudation', '5-6 hours denudation time', '6-7 hours denudation time', 'more than 7 hours denudation time']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Dian Tjahyadi', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitas Padjadjaran'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Anonymised data on oocytes and IVF procedures are only available upon reasonable written request to the authors team.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitas Padjadjaran', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}