Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2026-02-22 @ 6:44 PM
Study NCT ID:
NCT03323892
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2017-09-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Abstinence Duration on Embryo Development
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'a prospective sibling oocyte study: both study arms will be applied to the oocytes of 1 patient'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-04', 'studyFirstSubmitDate': '2017-09-05', 'studyFirstSubmitQcDate': '2017-10-26', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Embryo development (blastocyst stage)', 'timeFrame': '1 year', 'description': 'embryo development 5/6 of the preimplantation development'}, {'measure': 'Embryo development (cleavage stage)', 'timeFrame': '1 year', 'description': 'embryo development on day 3 of the preimplantation development'}], 'secondaryOutcomes': [{'measure': 'Fertilization', 'timeFrame': '1 year', 'description': 'number of fertilized oocytes per number of mature oocytes'}, {'measure': 'Utilization rate', 'timeFrame': '1 year', 'description': 'number of embryos used for transfer + cryopreserved for the patient'}, {'measure': 'Sperm quality', 'timeFrame': '1 year', 'description': 'concentration and motility'}, {'measure': 'Sperm DNA fragmentation', 'timeFrame': '1 year', 'description': 'analysis of non-viable sperm in the two samples'}, {'measure': 'Clinical Pregnancies', 'timeFrame': '1 year', 'description': 'pregnancies with a fetal heart beat'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['preimplantation development', 'DNA fragmentation', 'abstinence duration'], 'conditions': ['Embryo Development']}, 'descriptionModule': {'briefSummary': 'The aim the investigators study is to analyze the embryo development if oocytes of the participants are injected with sperm from a longer or shorter (2 hours) abstinence duration.', 'detailedDescription': 'Participants undergoing an IVF treatment, are asked to respect an abstinence duration of 2-7 days. This is to obtain a sufficient number of motile sperm. A recent investigation, analyzed the quality (number and motility) of a sperm sample produced after an abstinence duration of 4 to 7 days, followed by a second sperm sample 2 hours later. The second sample (after 2 hours) was able to produce sperm cells with a higher motility. Not only has this short abstinence duration of 2 hours a positive effect on the motility, it will also reduce the sperm DNA damage, which again has a positive effect on embryo development. Because participants need gametes of high quality to obtain embryos with a high quality, the investigators want to investigate what the effect is of abstinence duration on embryo development.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients planned for embryo development up to day 5\n* at least 6 mature oocytes\n* fresh ejaculates\n* ICSI\n* fresh embryo transfer or freeze all strategy\n* all stimulation protocols\n* concentration of \\>1x10\\^6 /ml sperm\n\nExclusion Criteria:\n\n* IVF\n* IVF versus ICSI patients\n* chirurgical sperm\n* acceptors of donor oocytes\n* patients with PGD\n* patients already enrolled in another study'}, 'identificationModule': {'nctId': 'NCT03323892', 'briefTitle': 'Effect of Abstinence Duration on Embryo Development', 'organization': {'class': 'OTHER', 'fullName': 'Universitair Ziekenhuis Brussel'}, 'officialTitle': 'Effect of Abstinence Duration on Embryo Development: a Prospective Sibling Oocyte Study', 'orgStudyIdInfo': {'id': '2017/271'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': "'normal' abstinence duration", 'description': 'Patients follow the normal abstinence duration as asked by the physician (2-7 days). This sperm will be used to inject half of the oocytes Intervention = second sperm sample', 'interventionNames': ['Other: second masturbation']}, {'type': 'EXPERIMENTAL', 'label': 'short abstinence duration', 'description': 'Patients will be asked to produce a second sperm sample, 2 hours after the first. This sperm will be used to inject the other half of the oocytes.\n\nIntervention = second sperm sample', 'interventionNames': ['Other: second masturbation']}], 'interventions': [{'name': 'second masturbation', 'type': 'OTHER', 'description': 'Husbands will be asked to produce a second sperm sample in the masturbatorium', 'armGroupLabels': ["'normal' abstinence duration", 'short abstinence duration']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Brussels', 'state': 'Brussels Capital', 'country': 'Belgium', 'facility': 'Universitair Ziekenhuis Brussel', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'overallOfficials': [{'name': 'Neelke De Munck, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitair Ziekenhuis Brussel'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No data available for researchers others than the ones involved in the study'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitair Ziekenhuis Brussel', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Embryologist', 'investigatorFullName': 'Neelke De Munck', 'investigatorAffiliation': 'Universitair Ziekenhuis Brussel'}}}}