Ignite Creation Date:
2025-12-24 @ 11:53 AM
Ignite Modification Date:
2025-12-24 @ 11:53 AM
Study NCT ID:
NCT03044561
Status:
UNKNOWN
Last Update Posted:
2017-02-07
First Post:
2017-02-02
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sildenafil Citrate of in Vitro Fertilization After Multiple IVF Failures Attributed to Poor Endometrial Development
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2017-09-06', 'releaseDate': '2017-08-09'}, {'resetDate': '2018-10-26', 'releaseDate': '2018-02-05'}], 'estimatedResultsFirstSubmitDate': '2017-08-09'}}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068677', 'term': 'Sildenafil Citrate'}, {'id': 'D013607', 'term': 'Tablets'}], 'ancestors': [{'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': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-01-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2017-08-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-02-03', 'studyFirstSubmitDate': '2017-02-02', 'studyFirstSubmitQcDate': '2017-02-03', 'lastUpdatePostDateStruct': {'date': '2017-02-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-02-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'endometrial thickness measures', 'timeFrame': '21 days', 'description': 'we will measure endometrial thickness by US in women with recurrent implantation failure'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['IVF Failure']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the effect of sildenafil citrate on endometrial development in women with history of recurrent implantation failure after IVF', 'detailedDescription': 'sildenafil citrate may increase endometrial thickness in women with recurrent IVF failure attributed to poor endometrial development'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* (1) cases of infertility, older than 20 years of age and not older than 40 years.\n* (2) Body mass index (BMI):20-29.\n* (3) women have experienced two or more implantation failure attributed to inadequate endometrial development.\n\nExclusion Criteria:\n\n* (1) Uterine abnormalities (e.g. septate, bicornuate and fibroid uterus, Asherman Syndrome).\n* (2) Any contraindication to sildenafil citrate or any of the components of its formulation including:\n\n * Concurrent use of organic nitrites and nitrates.\n * Severe hepatic impairment.\n * Severe renal impairment.\n * Hypotension.\n * Recent stroke or heart attack.'}, 'identificationModule': {'nctId': 'NCT03044561', 'briefTitle': 'Sildenafil Citrate of in Vitro Fertilization After Multiple IVF Failures Attributed to Poor Endometrial Development', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Effect of Sildenafil Citrate on the Outcome of in Vitro Fertilization After Multiple IVF Failures Attributed to Poor Endometrial Development', 'orgStudyIdInfo': {'id': 'amr el-sayed 2017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sildenafil citrate', 'interventionNames': ['Drug: Sildenafil Citrate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'interventionNames': ['Drug: matching placebo']}], 'interventions': [{'name': 'Sildenafil Citrate', 'type': 'DRUG', 'otherNames': ['Silden 25 mg tablet, EIPICO, Inc, Cairo, Egypt'], 'description': '25 mg orally, 4 times per day for 21 days', 'armGroupLabels': ['Sildenafil citrate']}, {'name': 'matching placebo', 'type': 'DRUG', 'otherNames': ['placebo'], 'description': 'orally, 4 times per day for 21 days', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'amr elsayed', 'role': 'CONTACT', 'phone': '01090808047'}], 'facility': 'Ain shams university', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'ahmed khairy, professor', 'role': 'CONTACT', 'phone': '01090808047'}], 'overallOfficials': [{'name': 'ahmed khairy, professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ain Shams University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Amr El-Sayed', 'investigatorAffiliation': 'Ain Shams University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2017-08-09', 'type': 'RELEASE'}, {'date': '2017-09-06', 'type': 'RESET'}, {'date': '2018-02-05', 'type': 'RELEASE'}, {'date': '2018-10-26', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Amr El-Sayed, principal investigator, Ain Shams University'}}}}