Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2026-02-27 @ 7:07 PM
Study NCT ID:
NCT04310293
Status:
UNKNOWN
Last Update Posted:
2020-07-08
First Post:
2020-03-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Novel Therapy for Poor Responders Management
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077289', 'term': 'Letrozole'}], 'ancestors': [{'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-07', 'studyFirstSubmitDate': '2020-03-08', 'studyFirstSubmitQcDate': '2020-03-14', 'lastUpdatePostDateStruct': {'date': '2020-07-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'NUMBER OF OOCYTES', 'timeFrame': '2 weeks', 'description': 'NUMBER'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['IVF', 'POOR RESPONDERS', 'GROWTH HORMONE'], 'conditions': ['Poor Ovarian Response']}, 'descriptionModule': {'briefSummary': 'Unfortunately for some infertile women, gonadotrophin administration results in a desultory ovarian response. While this is commonly due to diminished ovarian reserve, as indicated by advanced age and/or elevated basal day 3 FSH concentrations, a subset of these patients are \\<41 years old and have normal FSH concentrations.\n\nTo overcome this problem several strategies have been reported, with limited success.\n\nWith approval of the Board, 100 women with a history of previous poor response to vigorous gonadotrophin stimulation. All with AFC ≤3, AMH;≤0.5 and they give only ≤3 oocytes in their previous cycles will be included in this study using this new protocol: clomiphene citrate 150 for 7 days starting on DAY2, associated with HMG 300 IU \\& Groth hormone 8 units in alternating days (i.e.; HMG on D2,4,6,8 while GH on D3,5,7,9) then folliculomonitoring will be started on D9, then Antagonist may be added till triggering then will see the response compared to their own ovarian response before', 'detailedDescription': 'Unfortunately for some infertile women, gonadotrophin administration results in a desultory ovarian response. While this is commonly due to diminished ovarian reserve, as indicated by advanced age and/or elevated basal day 3 FSH concentrations, a subset of these patients are \\<41 years old and have normal FSH concentrations.\n\nTo overcome this problem several strategies have been reported, with limited success.\n\nWith approval of our Board, 100 women with a history of previous poor response to vigorous gonadotrophin stimulation. All with AFC ≤3, AMH;≤0.5 and they give only ≤3 oocytes in their previous cycles will be included in this study using this new protocol: clomiphene citrate 150 for 7 days starting on DAY2, associated with HMG 300 IU \\& Groth hormone 8 units in alternating days (i.e.; HMG on D2,4,6,8 while GH on D3,5,7,9) then folliculomonitoring will be started on D9, then Antagonist may be added till triggering then will see the response compared to their own ovarian response before in their previous trials'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '22 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All with AFC ≤3,\n* AMH;≤0.5\n* and they give only ≤3 oocytes in their previous cycles\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT04310293', 'briefTitle': 'Novel Therapy for Poor Responders Management', 'organization': {'class': 'OTHER', 'fullName': 'Al Baraka Fertility Hospital'}, 'officialTitle': 'Novel Therapy for Poor Responders Management', 'orgStudyIdInfo': {'id': 'Kamal-Rageh'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'POOR RESPONDERS', 'description': 'poor responders low AMH LOW AFC', 'interventionNames': ['Other: Femara,Grotwth hormone,HMG']}], 'interventions': [{'name': 'Femara,Grotwth hormone,HMG', 'type': 'OTHER', 'description': 'NOVEL THERAPY', 'armGroupLabels': ['POOR RESPONDERS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15006', 'city': 'Manama', 'status': 'RECRUITING', 'country': 'Bahrain', 'contacts': [{'name': 'AHMED BARAKAT, FRCOG', 'role': 'CONTACT', 'email': 'ahmed_barakat@yahoo.com', 'phone': '0097336660500'}, {'name': 'Kamal Rageh, M.D', 'role': 'CONTACT', 'email': 'dr_kamal_rageh@yahoo.com', 'phone': '0097333153871'}], 'facility': 'Al-BARAKA FERTILITY HOSPITAL', 'geoPoint': {'lat': 26.22787, 'lon': 50.58565}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Al Baraka Fertility Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'medical director', 'investigatorFullName': 'Dr. Kamal Rageh', 'investigatorAffiliation': 'Al Baraka Fertility Hospital'}}}}