Ignite Creation Date:
2025-12-24 @ 12:38 PM
Ignite Modification Date:
2026-02-12 @ 5:00 PM
Study NCT ID:
NCT02362061
Status:
COMPLETED
Last Update Posted:
2017-03-24
First Post:
2015-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
3D Ultrasound Measurement of Junctional Zone Thickness and Its Relation to Implantation Success
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-22', 'studyFirstSubmitDate': '2015-02-07', 'studyFirstSubmitQcDate': '2015-02-11', 'lastUpdatePostDateStruct': {'date': '2017-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-02-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pregnancy rate', 'timeFrame': '14 days after evaluation'}], 'secondaryOutcomes': [{'measure': 'healthy pregnancy', 'timeFrame': '6 weeks after pregnancy confirmation by pregnancy test'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['junctional zone', 'implantation', 'three D ultraosund', 'Assisted Reproductive Technology', 'Pregnancy'], 'conditions': ['Infertility']}, 'descriptionModule': {'briefSummary': '100 patients aged 21-40 years old, diagnosed as primary or secondary infertility . These patients are then assigned to receive fertility treatment (ovulation induction, ICSI, intrauterine insemination and IVF). They undergo a 3D vaginal ultrasound before treatment to measure the junctional zone thickness and followed up after treatment to determine the rate of implantation.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '100 patients aged 21-40 years old, diagnosed as primary or secondary infertility due to the following causes of infertility; ( Pelvic Inflammatory disease, dysovulation , tubal infertility, unexplained infertility, combined infertility or due to male factor ).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* infertile women\n\nExclusion Criteria:\n\n* congenital uterine anomalies medical disease contraindicating pregnancy'}, 'identificationModule': {'nctId': 'NCT02362061', 'briefTitle': '3D Ultrasound Measurement of Junctional Zone Thickness and Its Relation to Implantation Success', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Thickness of the Junctional Zone Measured by 3D Ultrasound and Its Relation to the Success/Failure Implantation Rates in Assisted Reproduction Techniques', 'orgStudyIdInfo': {'id': '128'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'pregnant', 'description': 'These patients are then assigned to receive fertility treatment (ovulation induction, ICSI, intrauterine insemination and IVF). They undergo a 3D vaginal ultrasound before treatment to measure the junctional zone thickness and followed up after treatment to determine the rate of implantation and they became pregnant', 'interventionNames': ['Radiation: 3D ultrasound']}, {'label': 'Non pregnant', 'description': 'These patients are then assigned to receive fertility treatment (ovulation induction, ICSI, intrauterine insemination and IVF). They undergo a 3D vaginal ultrasound before treatment to measure the junctional zone thickness and followed up after treatment to determine the rate of implantation and they remained non pregnant', 'interventionNames': ['Radiation: 3D ultrasound']}], 'interventions': [{'name': '3D ultrasound', 'type': 'RADIATION', 'description': 'ultrasound to measure the thickness of the junctional zone at day 21 of the cycle', 'armGroupLabels': ['Non pregnant', 'pregnant']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12151', 'city': 'Cairo', 'state': 'Cairo Governorate', 'country': 'Egypt', 'facility': 'Kasr Alainy medical school', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Ahmed M Maged, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kasr Alainy medical school'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Ahmed Maged', 'investigatorAffiliation': 'Cairo University'}}}}