Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2026-03-02 @ 7:43 AM
Study NCT ID:
NCT02422134
Status:
COMPLETED
Last Update Posted:
2016-06-29
First Post:
2015-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Novel Approach for Embryo Transfer Medium by Adding Cytokine to Hyaluronan Enriched Embryo Transfer Medium (Embryo Glue)
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': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-28', 'studyFirstSubmitDate': '2015-04-16', 'studyFirstSubmitQcDate': '2015-04-20', 'lastUpdatePostDateStruct': {'date': '2016-06-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-04-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pregnancy rate ( % )', 'timeFrame': '9 months'}], 'secondaryOutcomes': [{'measure': 'Implantation rate ( % )', 'timeFrame': '9 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pregnancy', 'implantation', 'Cytokine'], 'conditions': ['Infertility']}, 'descriptionModule': {'briefSummary': 'It was proven that the Cytokine granulocyte-Macrophage clony stimulating factor had been found naturally in reproductive tract so our target is to test its effect if added to embryo transfer medium.', 'detailedDescription': 'The IVF embryo transfer media design and upgrade underwent many ideas during the last 3 decades, we suppose that adding Cytokine GM-CSF as an endometrial modifier to already proven successful medium hyaluronan enriched medium to test the efficacy ipon pregnancy and implantation rate in vitro so we decide to design a trial to compare the clinical outcome by sibling embryo to be transferred into 2 groups and the same culture condition but with one arm with Cytokine and the other is traditional one and closely monitor the outcome within the 2 arms and record the results.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all patients\n\nExclusion Criteria:\n\n* above 40 years old'}, 'identificationModule': {'nctId': 'NCT02422134', 'briefTitle': 'Novel Approach for Embryo Transfer Medium by Adding Cytokine to Hyaluronan Enriched Embryo Transfer Medium (Embryo Glue)', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Ibn Sina Hospital'}, 'orgStudyIdInfo': {'id': 'Ibnsina IVF Sohag'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Cytokine plus Hyalurinan embryo transfer arm', 'description': 'To monitor the pregnancy and implantation of the patients in this arm after adding Cytokine to the embryo transfer medium.', 'interventionNames': ['Other: Cytokine group']}, {'type': 'NO_INTERVENTION', 'label': 'Hyalurinan embryo transfer group', 'description': 'To transfer the embryos using a Hyaluronan enriched medium only'}], 'interventions': [{'name': 'Cytokine group', 'type': 'OTHER', 'description': 'Testing the efficacy of adding Cytokine to embryo transfer medium', 'armGroupLabels': ['Cytokine plus Hyalurinan embryo transfer arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Asyut', 'country': 'Egypt', 'facility': 'Banon IVF center', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}, {'city': 'Sohag', 'country': 'Egypt', 'facility': 'Ibnsina IVF center', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ibn Sina Hospital', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Banon IVF Center Assiut, Egypt', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'IVF Lab Director', 'investigatorFullName': 'Muhammad Fawzy', 'investigatorAffiliation': 'Ibn Sina Hospital'}}}}