Ignite Creation Date:
2025-12-24 @ 4:55 PM
Ignite Modification Date:
2025-12-26 @ 10:17 PM
Study NCT ID:
NCT05680350
Status:
COMPLETED
Last Update Posted:
2023-01-11
First Post:
2022-12-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Relation Between MicroRNA 203 and 210 and Sparing the Laparoscopic Examination in Cases of Unexplained Infertility
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004715', 'term': 'Endometriosis'}], 'ancestors': [{'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2022-03-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-10', 'studyFirstSubmitDate': '2022-12-26', 'studyFirstSubmitQcDate': '2023-01-10', 'lastUpdatePostDateStruct': {'date': '2023-01-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'grading of endometriosis', 'timeFrame': '8 months', 'description': 'The diagnostic performance of estimated plasma levels of microRNA for diagnosis and grading endometriosis'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Infertility Unexplained', 'Endometriosis']}, 'descriptionModule': {'briefSummary': 'The study targets to evaluate the role of estimation of plasma expression levels of gene of microRNAs 203 and 210 in helping to diagnose and grade endometriosis. The study included women with unexplained infertility and clinical picture suggestive of presence of endometriosis were divided randomly into two groups: Control and study groups. All patients underwent exploratory laparotomy for diagnosis and grading of endometriosis if present. Patients of study group gave blood samples for estimation of plasma expression levels of microRNA 203 and 210 using qRT-PCR procedure.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 30-45 years old\n* Unexplained infertility\n\nExclusion Criteria:\n\n* Presence of other causes of infertility,\n* age out of the predetermined range,\n* the presence of immune disorders,\n* maintenance on immunosuppressive drugs'}, 'identificationModule': {'nctId': 'NCT05680350', 'briefTitle': 'Relation Between MicroRNA 203 and 210 and Sparing the Laparoscopic Examination in Cases of Unexplained Infertility', 'organization': {'class': 'OTHER', 'fullName': 'Benha University'}, 'officialTitle': 'Plasma Levels of Micro RNA 203 and 210 Might Spare the Exploratory Laparoscopy in Case of un Explained Infertility With Suspected Endometriosis', 'orgStudyIdInfo': {'id': 'RC 2.6.2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Study group', 'description': 'Study group Patients with unexplained infertility had estimated their Plasma Expression level for Gene"Micro RNA "203 \\& 210" by qRT-PCR followed by laparoscopic exploration', 'interventionNames': ['Procedure: Laparoscopic Exploration', 'Diagnostic Test: Estimation of Plasma Expression level of MICRO RNA 203 & 210']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'Control group Patients with unexplained infertility underwent laparoscopy only', 'interventionNames': ['Procedure: Laparoscopic Exploration']}], 'interventions': [{'name': 'Laparoscopic Exploration', 'type': 'PROCEDURE', 'description': 'Laparoscopic Exploration to diagnose \\& grade endometriosis', 'armGroupLabels': ['Control Group', 'Study group']}, {'name': 'Estimation of Plasma Expression level of MICRO RNA 203 & 210', 'type': 'DIAGNOSTIC_TEST', 'description': 'estimation of Plasma Expression level for Gene"Micro RNA "203 \\& 210" by qRT-PCR', 'armGroupLabels': ['Study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13511', 'city': 'Banhā', 'state': 'El- Qalyobia', 'country': 'Egypt', 'facility': 'Banha University', 'geoPoint': {'lat': 30.45977, 'lon': 31.1842}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Benha University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor of gynecology', 'investigatorFullName': 'Amr Sharaf Eldein', 'investigatorAffiliation': 'Benha University'}}}}