Ignite Creation Date:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2026-01-29 @ 9:08 AM
Study NCT ID:
NCT03647020
Status:
COMPLETED
Last Update Posted:
2023-05-17
First Post:
2018-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Oocytes With CLCG on ICSI Outcomes and Their Potential Relation to Pesticide Exposure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 633}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2017-06-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-16', 'studyFirstSubmitDate': '2018-08-23', 'studyFirstSubmitQcDate': '2018-08-24', 'lastUpdatePostDateStruct': {'date': '2023-05-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ICS outcomes of couples presenting differetn CLCG prevalence', 'timeFrame': '2years', 'description': "The aim of the present study was to investigate the ICSI outcomes of couples presenting different CLCG prevalence's of retrieved oocytes (low prevalence of CLCG; fewer than 25% \\[LCLCG\\] and high prevalence of CLCG; over 75% \\[HCLCG\\]) and its correlation to pesticide exposure zones in the region of Picardy, France."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['oocyte', 'ovarian stimulation', 'dysmorphic cytoplasm'], 'conditions': ['Pesticide Poisoning']}, 'descriptionModule': {'briefSummary': 'Oocyte quality is a key limiting factor in female fertility which is primarily reflected in morphological features. Centrally located cytoplasm granulation (CLCG) is one type of cytoplasmic dimorphism exhibited by oocytes that could be linked to pesticide exposure with a significant risk of decreased ICSI outcomes.\n\nThis retrospective study included 633 women who were part of an intracytoplasmic spermatozoa injection (ICSI) program between 2009 and 2011. The participants lived in the Picardy region of France and had been exposed to pesticides. The participants were divided in two groups based on prevalence of oocytes with CLCG (LCLCG \\[n= 83\\]: low prevalence of oocytes with CLCG under 25%. HCLCG \\[ n= 68\\]: high prevalence of CLCG over 75%). The embryological and clinical outcomes were analysed for both groups and were calculated using the difference between the two values.', 'detailedDescription': "Oocyte quality is a key limiting factor in female fertility which is primarily reflected in morphological features. Centrally located cytoplasm granulation (CLCG) is one type of cytoplasmic dimorphism exhibited by oocytes that could be linked to pesticide exposure with a significant risk of decreased ICSI outcomes.\n\nThis retrospective study included 633 women who were part of an intracytoplasmic spermatozoa injection (ICSI) program between 2009 and 2011. The participants lived in the Picardy region of France and had been exposed to pesticides. The participants were divided in two groups based on prevalence of oocytes with CLCG (LCLCG \\[n= 83\\]: low prevalence of oocytes with CLCG under 25%. HCLCG \\[ n= 68\\]: high prevalence of CLCG over 75%). The embryological and clinical outcomes were analysed for both groups and were calculated using the difference between the two values. The included population in the investigator's retrospective study consisted of 633 couples who attended a reproductive medical center and who were part of an ICSI program between 2009 and 2011."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The population in the retrospective study consisted of 633 couples who attended a reproductive medical center and who were part of an ICSI program between 2009 and 2011. The study population is described in Table\n\n1\\. In the selected couples, women were normo-responders (oocyte cohort over 5), under 35 years old, living in the Picardy, France region, and exhibited CLCG after oocyte morphology evaluation which was confirmed by a second embryologist (Fig. 1', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* couples who attendes a reproductive medical center\n* couples that were part of a ICSI program between 2009 and 2011\n* women were normo-responders\n* female \\> 18 years \\<35 yeas old\n\nExclusion Criteria:\n\n* female \\< 18 years \\> 35 yeas old\n* couple with severe male infertility factors on oocyte activation and subsequent embryo development'}, 'identificationModule': {'nctId': 'NCT03647020', 'acronym': 'CLCG-ICSI', 'briefTitle': 'Impact of Oocytes With CLCG on ICSI Outcomes and Their Potential Relation to Pesticide Exposure', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire, Amiens'}, 'officialTitle': 'Impact of Oocytes With CLCG on ICSI Outcomes and Their Potential Relation to Pesticide Exposure', 'orgStudyIdInfo': {'id': 'PI2017_843_0044'}}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Moncef Ben Khlifa, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU AMIENS'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire, Amiens', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}