Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-31 @ 6:01 AM
Study NCT ID:
NCT07309692
Status:
RECRUITING
Last Update Posted:
2025-12-30
First Post:
2025-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Different Modalities for the Evaluation of Patients With Peri-menopausal Bleeding
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015907', 'term': 'Hysteroscopy'}], 'ancestors': [{'id': 'D003944', 'term': 'Diagnostic Techniques, Obstetrical and Gynecological'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013513', 'term': 'Obstetric Surgical Procedures'}, {'id': 'D013509', 'term': 'Gynecologic Surgical Procedures'}, {'id': 'D013519', 'term': 'Urogenital Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 106}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-15', 'studyFirstSubmitDate': '2025-11-27', 'studyFirstSubmitQcDate': '2025-12-15', 'lastUpdatePostDateStruct': {'date': '2025-12-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-12-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The sensitivity and specificity of the 3D ultrasonography for the diagnosis of the causes of peri-menopausal bleeding as compared to hysteroscopy', 'timeFrame': '9 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ultrasonography', 'hysteroscopy'], 'conditions': ['Perimenopausal Bleeding']}, 'referencesModule': {'references': [{'pmid': '38471484', 'type': 'RESULT', 'citation': 'Dokara-Friedrich ML, Loeffler M, Shehaj I, Tahmasbi-Rad M, Gasimli B, Karn T, Sanhaji M, Becker S, Gasimli K. The Clinical Relevance of Fractional Curettage in the Diagnostic Management of Primary Endometrial Cancer. Gynecol Obstet Invest. 2024;89(4):311-322. doi: 10.1159/000538268. Epub 2024 Mar 12.'}, {'pmid': '39701007', 'type': 'RESULT', 'citation': 'Saponara S, Angioni S, Parry JP, Pacheco LA, Carugno J, Moawad N, Haimovich S, Lasmar RB, Dealberti D, Aksakal E, Urman B, Nappi L, Vitale SG. The Pivotal role of hysteroscopy in diagnosing subtle uterine lesions in infertile patients: Seeing the unseen can make the difference. Eur J Obstet Gynecol Reprod Biol. 2025 Feb;305:132-141. doi: 10.1016/j.ejogrb.2024.12.013. Epub 2024 Dec 9.'}, {'pmid': '40628082', 'type': 'RESULT', 'citation': 'Xydias EM, Liasidi PN, Papageorgouli D, Tsakos E, Gouliopoulos N, Thanasas I, Daponte A, Ziogas AC. Three-dimensional transvaginal ultrasound versus MRI in the diagnosis and classification of congenital uterine anomalies: A systematic review and meta-analysis. Eur J Obstet Gynecol Reprod Biol. 2025 Aug;312:114560. doi: 10.1016/j.ejogrb.2025.114560. Epub 2025 Jul 2.'}, {'pmid': '10550879', 'type': 'RESULT', 'citation': 'Tetlow RL, Richmond I, Manton DJ, Greenman J, Turnbull LW, Killick SR. Histological analysis of the uterine junctional zone as seen by transvaginal ultrasound. Ultrasound Obstet Gynecol. 1999 Sep;14(3):188-93. doi: 10.1046/j.1469-0705.1999.14030188.x.'}, {'pmid': '16487194', 'type': 'RESULT', 'citation': "Okaro E, Condous G, Khalid A, Timmerman D, Ameye L, Huffel SV, Bourne T. The use of ultrasound-based 'soft markers' for the prediction of pelvic pathology in women with chronic pelvic pain--can we reduce the need for laparoscopy? BJOG. 2006 Mar;113(3):251-6. doi: 10.1111/j.1471-0528.2006.00849.x."}, {'pmid': '18405088', 'type': 'RESULT', 'citation': 'Mukhopadhayay S, Bhattacharyya SK, Ganguly RP, Patra KK, Bhattacharya N, Barman SC. Comparative evaluation of perimenopausal abnormal uterine bleeding by transvaginal sonography, hysteroscopy and endometrial biopsy. J Indian Med Assoc. 2007 Nov;105(11):624, 626, 628 passim.'}, {'pmid': '24753775', 'type': 'RESULT', 'citation': 'Babacan A, Gun I, Kizilaslan C, Ozden O, Muhcu M, Mungen E, Atay V. Comparison of transvaginal ultrasonography and hysteroscopy in the diagnosis of uterine pathologies. Int J Clin Exp Med. 2014 Mar 15;7(3):764-9. eCollection 2014.'}, {'pmid': '33417634', 'type': 'RESULT', 'citation': 'Louis F, Lulla CP. Hysteroscopy is Superior to 3D Ultrasound in Gynecological Diagnosis. J Obstet Gynaecol India. 2020 Dec;70(6):447-461. doi: 10.1007/s13224-020-01384-8. Epub 2020 Dec 4. No abstract available.'}, {'pmid': '29606892', 'type': 'RESULT', 'citation': 'Kolhe S. Management of abnormal uterine bleeding - focus on ambulatory hysteroscopy. Int J Womens Health. 2018 Mar 22;10:127-136. doi: 10.2147/IJWH.S98579. eCollection 2018.'}, {'pmid': '32041387', 'type': 'RESULT', 'citation': 'Yasa C, Gungor Ugurlucan F. Approach to Abnormal Uterine Bleeding in Adolescents. J Clin Res Pediatr Endocrinol. 2020 Feb 6;12(Suppl 1):1-6. doi: 10.4274/jcrpe.galenos.2019.2019.S0200.'}, {'pmid': '30254909', 'type': 'RESULT', 'citation': 'Pandey D, Kunamneni S, Inukollu PR, Su H. Establishing patterns on hysteroscopy in abnormal uterine bleeding (AUB). Gynecol Minim Invasive Ther. 2017 Oct-Dec;6(4):178-182. doi: 10.1016/j.gmit.2017.08.001. Epub 2017 Aug 26.'}, {'pmid': '26537304', 'type': 'RESULT', 'citation': 'Ong CL. The current status of three-dimensional ultrasonography in gynaecology. Ultrasonography. 2016 Jan;35(1):13-24. doi: 10.14366/usg.15043. Epub 2015 Sep 25.'}, {'pmid': '26085733', 'type': 'RESULT', 'citation': 'Turkgeldi E, Urman B, Ata B. Role of Three-Dimensional Ultrasound in Gynecology. J Obstet Gynaecol India. 2015 May;65(3):146-54. doi: 10.1007/s13224-014-0635-z. Epub 2014 Nov 8.'}, {'pmid': '38487719', 'type': 'RESULT', 'citation': 'Wang L, Quan S, Bai E, Yang X. Analysis of clinical data of different endometrial pathological types in perimenopausal women with abnormal uterine bleeding. Front Oncol. 2024 Feb 29;14:1370681. doi: 10.3389/fonc.2024.1370681. eCollection 2024.'}, {'pmid': '38412750', 'type': 'RESULT', 'citation': 'Dreisler E, Frandsen CS, Ulrich L. Perimenopausal abnormal uterine bleeding. Maturitas. 2024 Jun;184:107944. doi: 10.1016/j.maturitas.2024.107944. Epub 2024 Feb 22.'}]}, 'descriptionModule': {'briefSummary': 'The study aims to compare between 3D ultrasonography and hysteroscopy for the evaluation of cases with Peri-menopausal bleeding'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAny pattern of abnormal uterine bleeding as menorrhagia or metrorrhagia for more than 3 months at age between 40 and 55 years , and no ovarian lesion or local cause of bleeding as vaginal or cervical ulcer\n\nExclusion Criteria:\n\n* • Women with postmenopausal bleeding.\n\n * Systemic causes of perimenopausal bleeding DM Hypertension or chronic liver disease.\n * Women on hormonal therapy or using any contraception as IUD.\n * Women have contraindication for hysteroscopy as cervical stenosis or pregnancy.'}, 'identificationModule': {'nctId': 'NCT07309692', 'briefTitle': 'Different Modalities for the Evaluation of Patients With Peri-menopausal Bleeding', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Three Dimensional Ultrasonography Versus Hysteroscopy for the Evaluation of Patients With Perimenopausal Bleeding', 'orgStudyIdInfo': {'id': 'Soh-Med-25-9----11MS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients with perimenopausal bleeding', 'interventionNames': ['Diagnostic Test: three dimensional ultrasonography', 'Diagnostic Test: Hysteroscopy']}], 'interventions': [{'name': 'three dimensional ultrasonography', 'type': 'DIAGNOSTIC_TEST', 'description': 'all recruited patients will be subjected to three dimensional ultrasonography to diagnose the cause of perimenopausal bleeding', 'armGroupLabels': ['Patients with perimenopausal bleeding']}, {'name': 'Hysteroscopy', 'type': 'DIAGNOSTIC_TEST', 'description': 'diagnostic hysteroscopy will be performed to diagnose the cause of perimenopausal bleeding', 'armGroupLabels': ['Patients with perimenopausal bleeding']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sohag', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'hatem aboelftooh awaga, assistant professor', 'role': 'CONTACT', 'email': 'hatemaboelftooh@yahoo.com', 'phone': '01550777310'}], 'facility': 'Sohag University', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}], 'centralContacts': [{'name': 'ahmed abdelrahem fattouh, resident of Obstetrics and Gyn', 'role': 'CONTACT', 'email': 'ahmedalatoon04@gmail.com', 'phone': '00201146329946'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident doctor at obstetric and gynecology department of sohag university', 'investigatorFullName': 'Ahmed Abd Al Rahim Fattouh', 'investigatorAffiliation': 'Sohag University'}}}}