Ignite Creation Date:
2025-12-24 @ 3:17 PM
Ignite Modification Date:
2025-12-27 @ 7:25 PM
Study NCT ID:
NCT01501292
Status:
UNKNOWN
Last Update Posted:
2011-12-29
First Post:
2011-12-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Changes in the Distribution of Mitochondria During Oocyte Maturation
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': 'D013194', 'term': 'Staining and Labeling'}], 'ancestors': [{'id': 'D016591', 'term': 'Histocytological Preparation Techniques'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D006652', 'term': 'Histological Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'completionDateStruct': {'date': '2012-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-12-26', 'studyFirstSubmitDate': '2011-12-13', 'studyFirstSubmitQcDate': '2011-12-26', 'lastUpdatePostDateStruct': {'date': '2011-12-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The patterns of mitochondrial distribution within the cytoplasma of oocytes during nuclear maturation', 'timeFrame': 'Three months', 'description': 'Identification the different patterns of mitochondrial distribution in correlation with the 3 stages nuclear maturation in human oocytes'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Infertility']}, 'descriptionModule': {'briefSummary': 'Cytoplasmatic maturation is an important event in the general maturation of of the oocyte. Mitochondria is one of the major organelles involved in the process of cytoplasmatic maturation. The aim of this study is to investigate the presence and distribution of the mitochondria in the cytoplasma of immature oocytes that are retrieved in the routine in-vitro maturation cycle with intracytoplasmatic sperm injection (ICSI). These oocytes will not undergo ICSI because of their immaturity. Usually, they are discarded. In addition to these immature oocytes the investigators shall also investigate the mitochondria in mature oocytes that underwent ICSI but did not become fertilized and are discarded.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '44 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing routine in-vitro fertilization with ICSI', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infertile patients needing IVF treatment\n\nExclusion Criteria:\n\n* Patients not requiring the ICSI procedure'}, 'identificationModule': {'nctId': 'NCT01501292', 'briefTitle': 'Changes in the Distribution of Mitochondria During Oocyte Maturation', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hillel Yaffe Medical Center'}, 'orgStudyIdInfo': {'id': '0095-11-HYMC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Immature oocytes (GV, M-I)', 'interventionNames': ['Other: Fixation and staining', 'Other: Observation by laser microscopy']}, {'label': 'Mature oocytes (M-II)', 'interventionNames': ['Other: Fixation and staining', 'Other: Observation by laser microscopy']}], 'interventions': [{'name': 'Fixation and staining', 'type': 'OTHER', 'description': 'Fixation and staining by MitiTracker Green FM', 'armGroupLabels': ['Immature oocytes (GV, M-I)', 'Mature oocytes (M-II)']}, {'name': 'Observation by laser microscopy', 'type': 'OTHER', 'description': 'Observation with Laser scanning confocal microscopy', 'armGroupLabels': ['Immature oocytes (GV, M-I)', 'Mature oocytes (M-II)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38100', 'city': 'Hadera', 'country': 'Israel', 'contacts': [{'name': 'Adrian Ellenbogen, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ofer Fainaru, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Tal Shavit, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hillel Yaffe Medical Center', 'geoPoint': {'lat': 32.44192, 'lon': 34.9039}}], 'centralContacts': [{'name': 'Adrian Ellenbogen, MD', 'role': 'CONTACT', 'email': 'ellenbogen@hy.health.gov.il', 'phone': '972-50-6246722'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hillel Yaffe Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}