Ignite Creation Date:
2025-12-24 @ 9:49 PM
Ignite Modification Date:
2025-12-25 @ 7:27 PM
Study NCT ID:
NCT04496232
Status:
COMPLETED
Last Update Posted:
2022-08-09
First Post:
2020-07-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Strategies for Reducing Sperm DNA Fragmentation in ICSI Semen Samples: a Prospective Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007248', 'term': 'Infertility, Male'}], 'ancestors': [{'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007246', 'term': 'Infertility'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-06', 'studyFirstSubmitDate': '2020-07-29', 'studyFirstSubmitQcDate': '2020-07-29', 'lastUpdatePostDateStruct': {'date': '2022-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fertilization rate', 'timeFrame': '16-19 hours', 'description': 'Defined as the proportion of fertilized oocytes over the injected oocytes.'}, {'measure': 'Cleavage rate', 'timeFrame': '3 days', 'description': 'Defined as the proportion of cleaved embryos on day 3 over the injected oocytes.'}, {'measure': 'Blastulation rate', 'timeFrame': '5-6 days', 'description': 'Defined as the proportion of blastocysts formed on day 5 or 6 over the cleaved embryos on day 3.'}, {'measure': 'Blastocyst quality rate', 'timeFrame': '5-6 days', 'description': "Defined as the assessment of blastocyst quality according to Gardner's criteria into: good, fair, or bad in terms of percentage of the total formed blastocysts."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sperm DNA fragmentation', 'Second ejaculate', 'Sperm Selection', 'PICSI'], 'conditions': ['Male Infertility']}, 'descriptionModule': {'briefSummary': 'Comparing second ejaculate and physiological ICSI (PICSI) as strategies for improvement of abnormal sperm DNA fragmentation in patients undergoing ICSI.', 'detailedDescription': 'Sperm DNA fragmentation has shown a negative correlation with embryo quality, fertilization, implantation, clinical pregnancy, and live birth rates. And a positive correlation with the miscarriage rate. Abnormal sperm DNA fragmentation can be improved through the second ejaculate strategy, by limiting the time of sperm presence in the epididymis. PICSI is a robust sperm selection technique that can select individual mature intact sperm DNA. In our study, we will compare PICSI as a valid sperm selection technique to second ejaculate, as a natural cost-free strategy to manage abnormal SDF. In addition to a normal SDF arm as a control.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male partner with abnormal sperm DNA fragmentation index (\\>20%) by TUNEL assay\n* Male partner with at least 1 million progressive motile count\n* Male aged 18-50 years\n* Male with adjusted sexual abstinence days (1-2 days)\n* Female aged 18-37 years\n* Normo-responder females (at least 5 mature oocytes)\n\nExclusion Criteria:\n\n* Leukocytospermia\n* Varicocele\n* Known genetic abnormality\n* Use of oocyte or sperm donors\n* Use of a gestational carrier\n* Presence of any endometrial factors that can affect embryo implantation\n* Any contradictions to undergoing in vitro fertilization or gonadotropin stimulation'}, 'identificationModule': {'nctId': 'NCT04496232', 'briefTitle': 'Strategies for Reducing Sperm DNA Fragmentation in ICSI Semen Samples: a Prospective Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Ganin Fertility Center'}, 'officialTitle': 'Strategies for Reducing Sperm DNA Fragmentation in ICSI Semen Samples: a Prospective Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'GFC-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Normal SDF', 'description': 'Using routine semen processing method'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Physiological ICSI (PICSI)', 'description': 'Sperm selection using PICSI dishes for selecting sperm with lower DNA fragmentation index for ICSI', 'interventionNames': ['Device: PICSI']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Second ejaculate', 'description': 'Using the second ejaculate as a way of reducing SDF in the semen sample used for ICSI', 'interventionNames': ['Other: Second ejaculate']}], 'interventions': [{'name': 'PICSI', 'type': 'DEVICE', 'description': 'Semen processing by density gradient centrifugation followed by sperm selection by PICSI dishes of the first ejaculate', 'armGroupLabels': ['Physiological ICSI (PICSI)']}, {'name': 'Second ejaculate', 'type': 'OTHER', 'description': 'Semen processing by density gradient centrifugation for the second ejaculate', 'armGroupLabels': ['Second ejaculate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11728', 'city': 'Cairo', 'state': 'Cairo Governorate', 'country': 'Egypt', 'facility': 'Ganin Fertility Center', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Eman Hasanen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ganin Fertility Center'}, {'name': 'Radwa Omar', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ganin Fertility Center'}, {'name': 'Hanaa Alkhader', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ganin Fertility Center'}, {'name': 'Hosam Zaki, MSc, FRCOG', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ganin Fertility Center'}, {'name': 'Manar Hozayen, MSc.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ganin Fertility Center'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ganin Fertility Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'BSc.', 'investigatorFullName': 'Eman Hasanen', 'investigatorAffiliation': 'Ganin Fertility Center'}}}}