Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2026-02-20 @ 6:52 PM
Study NCT ID:
NCT04184167
Status:
UNKNOWN
Last Update Posted:
2020-01-27
First Post:
2019-11-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of Intermittent Fasting Before ICSI
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-12-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2020-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-01-24', 'studyFirstSubmitDate': '2019-11-29', 'studyFirstSubmitQcDate': '2019-11-29', 'lastUpdatePostDateStruct': {'date': '2020-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the number of women who will have positive pregnancy test after ICSI', 'timeFrame': 'within 6 months', 'description': 'The women who will get pregnant after ICSI with positive pregnancy test'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Infertility']}, 'descriptionModule': {'briefSummary': 'intermittent fasting could have a role in infertility', 'detailedDescription': 'intermittent fasting could have a role in infertility and could adjust the body weight before ICSI'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '42 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'infertile women', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* women with infertility\n\nExclusion Criteria:\n\n* ovarian factor or uterine factor of infertility'}, 'identificationModule': {'nctId': 'NCT04184167', 'briefTitle': 'Role of Intermittent Fasting Before ICSI', 'organization': {'class': 'OTHER', 'fullName': 'Aljazeera Hospital'}, 'officialTitle': 'Role of Intermittent Fasting Before Intracytoplasmic Sperm Injection', 'orgStudyIdInfo': {'id': 'Role of intermittent fasting'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'intermittent fasting', 'description': 'intermittent fasting before ICSI', 'interventionNames': ['Other: intermittent fasting 4 months before ICSI']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'No intermittent fasting', 'description': 'Usual diet', 'interventionNames': ['Other: intermittent fasting 4 months before ICSI']}], 'interventions': [{'name': 'intermittent fasting 4 months before ICSI', 'type': 'OTHER', 'description': 'women will start intermittent fasting before starting ICSI by 4 months', 'armGroupLabels': ['No intermittent fasting', 'intermittent fasting']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Giza', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mahmoud Alalfy, master', 'role': 'CONTACT', 'email': 'mahmoudalalfy@ymail.com', 'phone': '+201002611058'}, {'name': 'Ahmed Elgazzar, M.D', 'role': 'CONTACT', 'phone': '+201014005959'}, {'name': 'Mahmoud Alalfy, master', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Algazeerah and helwan university', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}, {'city': 'Giza', 'status': 'NOT_YET_RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mahmoud Alalfy, master', 'role': 'CONTACT', 'email': 'mahmoudalalfy@ymail.com', 'phone': '+201002611058'}, {'name': 'Ahmed Elgazzar, M.D', 'role': 'CONTACT', 'phone': '+201014005959'}, {'name': 'Mahmoud Alalfy, master', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Algazeerah', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}], 'overallOfficials': [{'name': 'Mahmoud Alalfy, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Algezeera hospitaland National Research Centre ,Egypt'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aljazeera Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Research Centre, Egypt', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}