Ignite Creation Date:
2025-12-24 @ 11:09 PM
Ignite Modification Date:
2025-12-25 @ 8:43 PM
Study NCT ID:
NCT06250569
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-09
First Post:
2024-01-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Adenomyosis in Fertile Women in MUSA Criteria
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D062788', 'term': 'Adenomyosis'}], 'ancestors': [{'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'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 144}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-01', 'studyFirstSubmitDate': '2024-01-26', 'studyFirstSubmitQcDate': '2024-02-01', 'lastUpdatePostDateStruct': {'date': '2024-02-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'adenomyosis in fertile women', 'timeFrame': '1.5 year', 'description': 'Estimation of the prevalence of adenomyosis diagnosed using revised MUSA criteria among fertile women aged 18-30 years.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Adenomyosis']}, 'referencesModule': {'references': [{'pmid': '22510618', 'type': 'BACKGROUND', 'citation': 'Marion LL, Meeks GR. Ectopic pregnancy: History, incidence, epidemiology, and risk factors. Clin Obstet Gynecol. 2012 Jun;55(2):376-86. doi: 10.1097/GRF.0b013e3182516d7b.'}, {'pmid': '19007632', 'type': 'BACKGROUND', 'citation': 'Practice Committee of American Society for Reproductive Medicine. Medical treatment of ectopic pregnancy. Fertil Steril. 2008 Nov;90(5 Suppl):S206-12. doi: 10.1016/j.fertnstert.2008.08.049.'}, {'pmid': '38042476', 'type': 'BACKGROUND', 'citation': 'Karol D, Williamson M, Pereira N. Successful Expectant Management of a Tubal Ectopic Pregnancy. J Minim Invasive Gynecol. 2024 Feb;31(2):92-94. doi: 10.1016/j.jmig.2023.11.011. Epub 2023 Nov 30. No abstract available.'}, {'pmid': '34587658', 'type': 'BACKGROUND', 'citation': 'Harmsen MJ, Van den Bosch T, de Leeuw RA, Dueholm M, Exacoustos C, Valentin L, Hehenkamp WJK, Groenman F, De Bruyn C, Rasmussen C, Lazzeri L, Jokubkiene L, Jurkovic D, Naftalin J, Tellum T, Bourne T, Timmerman D, Huirne JAF. Consensus on revised definitions of Morphological Uterus Sonographic Assessment (MUSA) features of adenomyosis: results of modified Delphi procedure. Ultrasound Obstet Gynecol. 2022 Jul;60(1):118-131. doi: 10.1002/uog.24786.'}]}, 'descriptionModule': {'briefSummary': '1. To estimate the prevalence of adenomyosis in fertile women aged 18-30 years using the revised MUSA ultrasound criteria.\n2. To evaluate clinical risk factors that are associated with adenomyosis diagnosis in this population', 'detailedDescription': 'Adenomyosis is a benign condition characterized by the presence endometrial glands and stroma within the myometrium. Its prevalence varies from 5-70%. The definitive diagnosis of adenomyosis is based mainly on histological assessment of hysterectomy specimens. This led to a concept that adenomyosis affects only parous women between 35-50 years who complain of dysmenorrhea and heavy menstrual bleeding. Magnetic Resonance Imaging (MRI) can detect adenomyosis with a sensitivity of 80%. Transvaginal ultrasound using the revised Morphological Uterus Sonographic Assessment (MUSA) criteria can detect adenomyosis non-invasively at a lower cost. Such advancements in imaging techniques allow studying the prevalence of the disease in wider range of population including young women.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study will include women with regular menstrual cycle attending outpatient clinic for contraception counseling( age 18 -30 years old ; written consent will be obtained )', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* women with regular menstrual cycle attending outpatient clinic for contraception counseling\n* age 18 -30 years old\n\nExclusion Criteria:\n\n* Women on hormonal contraception\n* Infertile women\n* Associated pathologies like endometriosis, uterine fibroids. and ovarian cysts'}, 'identificationModule': {'nctId': 'NCT06250569', 'briefTitle': 'Adenomyosis in Fertile Women in MUSA Criteria', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Application of the Revised Morphological Uterus Sonographic Assessment (MUSA) Criteria to Diagnose Adenomyosis in Fertile Women', 'orgStudyIdInfo': {'id': 'Adenomyosis in fertile womens'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'first group', 'description': 'women with with adenomyosis'}, {'label': 'second group', 'description': 'women without adenomyosis'}]}, 'contactsLocationsModule': {'locations': [{'zip': '71515', 'city': 'Asyut', 'country': 'Egypt', 'contacts': [{'name': 'Aya Nour Elzanaty', 'role': 'CONTACT', 'email': 'Aya.elzanaty214@gmail.com', 'phone': '01022739886'}], 'facility': 'Assuit university', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'Aya Nour elzanaty, MBBch', 'role': 'CONTACT', 'email': 'Aya.elzanaty214@gmail.com', 'phone': '01022739886'}, {'name': 'Essam Rashad, Prof', 'role': 'CONTACT', 'email': 'essamothman@aun.edu.eg', 'phone': '01001330534'}], 'overallOfficials': [{'name': 'safwat abdelrady, Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assiut University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal invistigator', 'investigatorFullName': 'Aya nour Elzanaty', 'investigatorAffiliation': 'Assiut University'}}}}