Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2026-01-03 @ 8:36 PM
Study NCT ID:
NCT05971667
Status:
UNKNOWN
Last Update Posted:
2023-08-03
First Post:
2023-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Tadalafil, Sildenafil and Pentoxyfylline on Frozen Embryo Transfer Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068581', 'term': 'Tadalafil'}, {'id': 'D000068677', 'term': 'Sildenafil Citrate'}, {'id': 'D010431', 'term': 'Pentoxifylline'}], 'ancestors': [{'id': 'D002243', 'term': 'Carbolines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D013805', 'term': 'Theobromine'}, {'id': 'D014970', 'term': 'Xanthines'}, {'id': 'D011688', 'term': 'Purinones'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-07-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-01', 'studyFirstSubmitDate': '2023-07-25', 'studyFirstSubmitQcDate': '2023-07-25', 'lastUpdatePostDateStruct': {'date': '2023-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'endometrial thickness', 'timeFrame': 'within 16 day of menstruation', 'description': 'measured by transvaginal ultrasound'}], 'secondaryOutcomes': [{'measure': 'pregnancy rate', 'timeFrame': '1 month', 'description': 'number of cases positive serum pregnancy test'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tadalafil', 'Sildenafil', 'pentoxyfylline', 'frozen embryo transfer'], 'conditions': ['IVF']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate the Effect of different vasodilators as Tadalafil, Sildenafil and pentoxyfylline in In vitro Fertilization. In addition, the thickness of endometrium and pregnancies rates of these women will also be examined. All adverse effects of all drugs will be estimated', 'detailedDescription': 'A prospective randomized clinical study will be conducted in the IVF clinic of the gynecology department of Beni Suef University Hospital, Beni-Suef, Egypt. The study will These patients will be randomized into four groups.\n\nThe participants will take drugs starting from the end of menstruation cycle till endometrium reach optimal and then will start progesterone 800 mg daily.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* women having thawed embryos\n\nExclusion Criteria:\n\n* hypotension\n* cardiovascular, hepatic, and renal diseases;\n* uncontrolled diabetes mellitus;\n* ovarian cysts;\n* hyperprolactinemia;\n* abnormal thyroid functions;\n* uterine fibroids;\n* patients taking nitrates;\n* endometriosis and adenomyosis'}, 'identificationModule': {'nctId': 'NCT05971667', 'briefTitle': 'Effect of Tadalafil, Sildenafil and Pentoxyfylline on Frozen Embryo Transfer Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'Beni-Suef University'}, 'officialTitle': '"Effect of Tadalafil, Sildenafil and Pentoxyfylline on Endometrial Thickness and Frozen Embryo Transfer Outcomes', 'orgStudyIdInfo': {'id': 'Tadalafil IVF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'tadalafil', 'description': 'tadalafil 10 mg one tablet daily', 'interventionNames': ['Drug: tadalafil']}, {'type': 'EXPERIMENTAL', 'label': 'pentoxifylline', 'description': 'pentoxyfilline 400 mg two tabs daily', 'interventionNames': ['Drug: pentoxifylline']}, {'type': 'EXPERIMENTAL', 'label': 'sildenafil', 'description': 'sildenafil 20 mg two tablets', 'interventionNames': ['Drug: Sildenafil']}, {'type': 'NO_INTERVENTION', 'label': 'control group.', 'description': 'no intervention is given'}], 'interventions': [{'name': 'tadalafil', 'type': 'DRUG', 'otherNames': ['cialong'], 'description': 'tadalafil 10 mg one tablet daily', 'armGroupLabels': ['tadalafil']}, {'name': 'Sildenafil', 'type': 'DRUG', 'otherNames': ['Respatio'], 'description': 'sildenafil 20 mg two tablets daily', 'armGroupLabels': ['sildenafil']}, {'name': 'pentoxifylline', 'type': 'DRUG', 'otherNames': ['trental'], 'description': 'pentoxifylline 400 mg two tabs daily', 'armGroupLabels': ['pentoxifylline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '62521', 'city': 'Banī Suwayf', 'state': 'Beni Suweif Governorate', 'country': 'Egypt', 'facility': 'Beni-suef university Hospital', 'geoPoint': {'lat': 29.07441, 'lon': 31.09785}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beni-Suef University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University', 'investigatorFullName': 'Sara Abdallah Mohamed Salem', 'investigatorAffiliation': 'Beni-Suef University'}}}}