Ignite Creation Date:
2025-12-24 @ 10:14 PM
Ignite Modification Date:
2026-01-06 @ 5:22 PM
Study NCT ID:
NCT02455635
Status:
COMPLETED
Last Update Posted:
2017-03-21
First Post:
2015-05-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lower Abdominal Pain During Office Hysteroscopy Can Assess Tubal Patency in Infertile Women
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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-18', 'studyFirstSubmitDate': '2015-05-21', 'studyFirstSubmitQcDate': '2015-05-27', 'lastUpdatePostDateStruct': {'date': '2017-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-05-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'lower abdominal pain as measured by Visual Analog Scale', 'timeFrame': 'at time of hystroscopy till 15 minutes after end of procedure', 'description': 'Pain, as measured by Visual Analog Scale'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Office Hysteroscopy', 'tubal patency', 'infertility', 'Lower Abdominal Pain'], 'conditions': ['Infertility']}, 'descriptionModule': {'briefSummary': 'Office hysteroscopy through vaginoscopic approach was done in gynecology out-patient clinic with saline distension medium. The presence or absence of lower abdominal pain and the side of pain were recorded. Then, transvaginal sonography within 20 minutes was done to detect the presence of free fluid in the pouch of Douglas. Then, laparoscopy with tubal chromopertubation was done.', 'detailedDescription': 'Office hysteroscopy through vaginoscopic approach was done in gynecology out-patient clinic using a 4 mm endoscopic sheath \\& 30 ᵒ endoscopic camera with saline distension medium using 90-100 mmHg pressure. Meanwhile, the presence or absence of lower abdominal pain and the side of pain were recorded. Then, transvaginal sonography within 20 minutes was done to detect the presence of free fluid in the pouch of Douglas.Then, laparoscopy with tubal chromopertubation was done.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infertile women normal semen analysis\n\nExclusion Criteria:\n\n* Ladies with evidence of upper or lower genital tract infections,\n* presence of free fluid in the pouch of Douglas before hysteroscopy or pelvic pathology or those with cervical stenosis that required cervical dilatation prior to hysteroscopy'}, 'identificationModule': {'nctId': 'NCT02455635', 'briefTitle': 'Lower Abdominal Pain During Office Hysteroscopy Can Assess Tubal Patency in Infertile Women', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Lower Abdominal Pain During Office Hysteroscopy As A Guide In The Assessment Of Tubal Patency In Infertile Women', 'orgStudyIdInfo': {'id': '135'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'women with pain', 'description': 'women who felt pain at time of office hystroscopy at time of saline infusion and for 15 minutes after end of procedure', 'interventionNames': ['Procedure: office hystroscopy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'women without pain', 'description': "women who didn't feel pain at time of office hystroscopy at time of saline infusion and for 15 minutes after end of procedure", 'interventionNames': ['Procedure: office hystroscopy']}], 'interventions': [{'name': 'office hystroscopy', 'type': 'PROCEDURE', 'description': 'Office hysteroscopythrough vaginoscopic approach was done in gynecology out-patient clinic using a 4 mm endoscopic sheath \\& 30 ᵒ endoscopic camera with saline distension medium using 90-100 mmHg pressure', 'armGroupLabels': ['women with pain', 'women without pain']}]}, '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 Maged', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kasr Alainy medical school'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Ahmed Maged', 'investigatorAffiliation': 'Cairo University'}}}}