Ignite Creation Date:
2025-12-24 @ 7:30 PM
Ignite Modification Date:
2025-12-29 @ 11:50 AM
Study NCT ID:
NCT05823103
Status:
UNKNOWN
Last Update Posted:
2023-04-21
First Post:
2023-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
New Pre-Surgical Scoring System for Uterine Septum
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000093665', 'term': 'Septate Uterus'}, {'id': 'C562565', 'term': 'Uterine Anomalies'}], 'ancestors': [{'id': 'D000093662', 'term': 'Uterine Duplication Anomalies'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-11-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-08', 'studyFirstSubmitDate': '2023-03-27', 'studyFirstSubmitQcDate': '2023-04-08', 'lastUpdatePostDateStruct': {'date': '2023-04-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with Complete Septum Correction', 'timeFrame': '1 month', 'description': 'No residual septum on 3D ultrasound'}, {'measure': 'Percentage of patients who had an intra-operative Uterine perforation', 'timeFrame': 'during the surgery', 'description': 'Diminishing the risk of intra-operative perforation of the fundus'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hysterscopy', 'Congenital Uterine Anomaly', 'Uterine Septum', 'Septet Uterus', 'Novel Scoring System', 'Shawki Septum Scoring System'], 'conditions': ['Septate Uterus']}, 'referencesModule': {'references': [{'pmid': '30290803', 'type': 'RESULT', 'citation': 'Rikken JFW, Kowalik CR, Emanuel MH, Bongers MY, Spinder T, de Kruif JH, Bloemenkamp KWM, Jansen FW, Veersema S, Mulders AGMGJ, Thurkow AL, Hald K, Mohazzab A, Khalaf Y, Clark TJ, Farrugia M, van Vliet HA, Stephenson MS, van der Veen F, van Wely M, Mol BWJ, Goddijn M. The randomised uterine septum transsection trial (TRUST): design and protocol. BMC Womens Health. 2018 Oct 5;18(1):163. doi: 10.1186/s12905-018-0637-6.'}, {'pmid': '27235766', 'type': 'RESULT', 'citation': 'Practice Committee of the American Society for Reproductive Medicine. Electronic address: ASRM@asrm.org; Practice Committee of the American Society for Reproductive Medicine. Uterine septum: a guideline. Fertil Steril. 2016 Sep 1;106(3):530-40. doi: 10.1016/j.fertnstert.2016.05.014. Epub 2016 May 25.'}, {'pmid': '36832295', 'type': 'RESULT', 'citation': 'Alcazar JL, Carriles I, Cajas MB, Costa S, Fabra S, Cabrero M, Castro E, Tomaizeh A, Laza MV, Monroy A, Martinez I, Aguilar MI, Hernani E, Castellet C, Oliva A, Pascual MA, Guerriero S. Diagnostic Performance of Two-Dimensional Ultrasound, Two-Dimensional Sonohysterography and Three-Dimensional Ultrasound in the Diagnosis of Septate Uterus-A Systematic Review and Meta-Analysis. Diagnostics (Basel). 2023 Feb 20;13(4):807. doi: 10.3390/diagnostics13040807.'}, {'pmid': '33793794', 'type': 'RESULT', 'citation': 'Rikken JFW, Kowalik CR, Emanuel MH, Bongers MY, Spinder T, Jansen FW, Mulders AGMGJ, Padmehr R, Clark TJ, van Vliet HA, Stephenson MD, van der Veen F, Mol BWJ, van Wely M, Goddijn M. Septum resection versus expectant management in women with a septate uterus: an international multicentre open-label randomized controlled trial. Hum Reprod. 2021 Apr 20;36(5):1260-1267. doi: 10.1093/humrep/deab037.'}, {'pmid': '20492650', 'type': 'RESULT', 'citation': 'Nouri K, Ott J, Huber JC, Fischer EM, Stogbauer L, Tempfer CB. Reproductive outcome after hysteroscopic septoplasty in patients with septate uterus--a retrospective cohort study and systematic review of the literature. Reprod Biol Endocrinol. 2010 May 21;8:52. doi: 10.1186/1477-7827-8-52.'}, {'pmid': '12870384', 'type': 'RESULT', 'citation': 'Agostini A, Bretelle F, Cravello L, Ronda I, Roger V, Blanc B. [Complications of operative hysteroscopy]. Presse Med. 2003 May 24;32(18):826-9. French.'}]}, 'descriptionModule': {'briefSummary': 'Comparing surgical outcomes of Hysteroscopic metroplasty for uterine septum when using the standard ESGE or ASRM classifications vs the novel scoring system dubbed Shawki Septum Scoring System.\n\nOutcomes based primarily on completion of the septal correction (no residual parts) and avoiding complications, the most significant of which are uterine perforation.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Uterine Septum diagnosed by 3D ultrasound\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT05823103', 'briefTitle': 'New Pre-Surgical Scoring System for Uterine Septum', 'organization': {'class': 'OTHER', 'fullName': 'Ebtesama Hospital'}, 'officialTitle': 'Uterine Septum: Novel Pre-surgical Scoring System to Aid and Standardise Hysteroscopic Metroplasty', 'orgStudyIdInfo': {'id': '100032023001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Hysteroscopic Metroplasty using ESHRE ASRM Classification', 'interventionNames': ['Diagnostic Test: ESHRE ASRM Classification']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Hysteroscopic Metroplasty using Shawki Septum Scoring System', 'interventionNames': ['Diagnostic Test: Shawki Septum Scoring System']}], 'interventions': [{'name': 'Shawki Septum Scoring System', 'type': 'DIAGNOSTIC_TEST', 'description': 'Utilising the novel scoring system to facilitate feasibility and safety of hysteroscopic metroplasty for uterine septum', 'armGroupLabels': ['Hysteroscopic Metroplasty using Shawki Septum Scoring System']}, {'name': 'ESHRE ASRM Classification', 'type': 'DIAGNOSTIC_TEST', 'description': 'Utilising the current classification before performing hysteroscopic metroplasty', 'armGroupLabels': ['Hysteroscopic Metroplasty using ESHRE ASRM Classification']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11835', 'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Yehia Shawki, MRCOG', 'role': 'CONTACT', 'email': 'yehiaoshawki@gmail.com', 'phone': '00201001226662'}], 'facility': 'Shifa Hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Yehia Shawki, MRCOG', 'role': 'CONTACT', 'email': 'yehiaoshawki@gmail.com', 'phone': '00201001226662'}], 'overallOfficials': [{'name': 'Yehia Shawki, MRCOG', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Endo-Planet'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': '1 year following completion', 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ebtesama Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Endoscopy Unit', 'investigatorFullName': 'Yehia Shawki', 'investigatorAffiliation': 'Ebtesama Hospital'}}}}