Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2025-12-26 @ 3:35 AM
Study NCT ID:
NCT04627818
Status:
RECRUITING
Last Update Posted:
2024-09-19
First Post:
2020-11-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Diagnostic, Therapeutic and Reproductive Aspects of Patients with Mullerian Anomalies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020345', 'term': 'Enterocolitis, Necrotizing'}], 'ancestors': [{'id': 'D004760', 'term': 'Enterocolitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2050-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-05', 'studyFirstSubmitDate': '2020-11-09', 'studyFirstSubmitQcDate': '2020-11-09', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2050-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fertility', 'timeFrame': '10 years after trying to conceive', 'description': 'Time to clinical pregnancy'}, {'measure': 'Fertility', 'timeFrame': '18 weeks after conception', 'description': 'Early pregnancy loss'}, {'measure': 'Surgical approach', 'timeFrame': 'During surgery', 'description': 'Different surgical approaches used'}, {'measure': 'Surgical success', 'timeFrame': '15 years after surgery', 'description': 'Relief of symptoms after surgery'}], 'secondaryOutcomes': [{'measure': 'Diagnostic accuracy', 'timeFrame': 'at the time of diagnostic workup', 'description': 'The ability of a test to detect a Mullerian variation when it is present and detect the absence of a Mullerian variation when it is absent'}, {'measure': 'Obstetric complications', 'timeFrame': '1 year after conception', 'description': 'Complications during pregnancy, labor, delivery, and the postpartum period'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mullerian anomaly', 'Diagnostic tools', 'Surgical treatment', 'Reproductive function', 'Obstetric complications'], 'conditions': ['Mullerian Anomaly of Uterus, Nec', 'Mullerian Anomaly of Vagina', 'Mullerian Anomaly of Cervix']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to get a better understanding of the clinical implications (including reproductive problems and obstetric complications), appropriate diagnostic tools and correct surgical treatment of Mullerian anomalies.', 'detailedDescription': 'Mullerian anomalies are rare, therefore they are not well known and not often considered as differential diagnosis. This causes a delay in the diagnosis with risk of long lasting symptoms and adverse effects on the reproductive function. However, the diagnosis can be made more accurately with improved diagnostic tools. Moreover, minimally invasive surgery allows for preservation and potential improvement of fertility in these women.\n\nThe purpose of this study is to get a better understanding of the clinical implications (including reproductive problems and obstetric complications), appropriate diagnostic tools and correct surgical treatment of Mullerian anomalies.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '45 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'diagnosed and/or treated in the Ghent University Hospital', 'genderDescription': 'women with a uterus', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* women with a uterus\n* presence of a mullerian variation\n* Maximum age 45y\n\nExclusion Criteria:\n\n* women without a uterus\n* aged \\>45y'}, 'identificationModule': {'nctId': 'NCT04627818', 'acronym': 'MULAN', 'briefTitle': 'Diagnostic, Therapeutic and Reproductive Aspects of Patients with Mullerian Anomalies', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Ghent'}, 'officialTitle': 'Diagnostic, Therapeutic and Reproductive Aspects of Patients with Mullerian Anomalies: a Prospective Cohort', 'orgStudyIdInfo': {'id': 'B6702020000011'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients with a mullerian variation'}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Ghent', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Eline Meireson', 'role': 'CONTACT', 'email': 'eline.meireson@uzgent.be', 'phone': '+3193327817'}], 'facility': 'Ghent University hospital', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}], 'centralContacts': [{'name': 'Eline Meireson', 'role': 'CONTACT', 'email': 'eline.meireson@uzgent.be', 'phone': '093327817', 'phoneExt': '0032'}], 'overallOfficials': [{'name': 'Tjalina Hamerlynck', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Ghent'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Ghent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}