Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2026-02-26 @ 12:43 AM
Study NCT ID:
NCT01634633
Status:
UNKNOWN
Last Update Posted:
2012-07-06
First Post:
2012-07-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endometrial Nerve Fibers Detection in Patients With Different Gynecological Pathologies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-07-05', 'studyFirstSubmitDate': '2012-07-03', 'studyFirstSubmitQcDate': '2012-07-05', 'lastUpdatePostDateStruct': {'date': '2012-07-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevelencce of endometrial nerve fibers', 'timeFrame': '18 months', 'description': 'Is to determine the prevelence of endometrial nerve fibers in different gynecological pathologies I via endometrial sampling'}], 'secondaryOutcomes': [{'measure': 'Pelvic pain', 'timeFrame': '18 months', 'description': 'Relating the density of endometrial nerve fibres to different types of pelvic pain'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Endometrial nerve fibres'], 'conditions': ['Gynecological Pathologies']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate the prevelence of endometrial nerve fibers in different gynecological pathologies', 'detailedDescription': 'The aim of this study is to investigate the prevelence of endometrial nerve fibers in different gynecological pathologies in addition to its relation to chronic pelvic pain'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The population of this study will be 300 patient undergoing laparoscopy or laparotomy for different gynecological diseases namely, polycystic ovarian disease (PCOD), ovarian cysts either benign or malignant, fibroid uterus, adenomyosis, endometrial hyperplasia and endometrial carcinoma', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age: 20-60 years of age.\n2. Written and signed informed consent by the patient to participate in the study.\n3. Women candidate for surgical intervention either via laparoscopy or laparotomy for different gynecological pathologies\n\nExclusion Criteria:\n\n1. Suspected endometriosis.\n2. Patient unwillingness to participate in the study.\n3. No hormonal treatment for the last 6 months.\n4. Suspected pregnancy.'}, 'identificationModule': {'nctId': 'NCT01634633', 'briefTitle': 'Endometrial Nerve Fibers Detection in Patients With Different Gynecological Pathologies', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams Maternity Hospital'}, 'officialTitle': 'Endometrial Nerve Fibers Detection in Patients With Different Gynecological Pathologies', 'orgStudyIdInfo': {'id': 'ENFD-25-2012'}, 'secondaryIdInfos': [{'id': 'Ain shams maternity hospital', 'type': 'OTHER_GRANT', 'domain': 'Ain shams maternity hospital'}]}, 'contactsLocationsModule': {'locations': [{'zip': '11591', 'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Reda MK Ghanem, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Reda MK Ghanem, M.B.B.Ch', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ain shams new maternity hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Ahmed EH Elbohoty, MD', 'role': 'CONTACT', 'email': 'elbohoty79@yahoo.com', 'phone': '22590767', 'phoneExt': '00202'}, {'name': 'Karim HI Abd-El-Maeboud, MD', 'role': 'CONTACT', 'email': 'kabdelmaeboud@yahoo. com', 'phone': '24140680', 'phoneExt': '+202'}], 'overallOfficials': [{'name': 'Reda MK Ghanem, M.B.B.Ch', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ain Shams University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams Maternity Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Mr', 'investigatorFullName': 'reda mokhtar kamal ghanem', 'investigatorAffiliation': 'Ain Shams University'}}}}