Ignite Creation Date:
2025-12-25 @ 3:10 AM
Ignite Modification Date:
2026-01-09 @ 3:26 PM
Study NCT ID:
NCT05537805
Status:
UNKNOWN
Last Update Posted:
2022-09-13
First Post:
2022-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound Guided Fallopian Tube Catheterization During Hysterosalpingo-foam Sonography (HyFoSy)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005184', 'term': 'Fallopian Tube Diseases'}], 'ancestors': [{'id': 'D000291', 'term': 'Adnexal 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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Prospective cohort study in a tertiary referral center. Investigators evaluated the procedure on a group of 30 participants that were referred to our unit for proximal tubal occlusion demonstrated by hysterosalpingo-foam sonography or hysterosalpingography.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-10-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2024-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-08', 'studyFirstSubmitDate': '2022-09-04', 'studyFirstSubmitQcDate': '2022-09-08', 'lastUpdatePostDateStruct': {'date': '2022-09-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with proximal tubal obstruction who referred for tubal catheterization in order to achieve fallopian tube recanalization (patency).', 'timeFrame': '18 month', 'description': 'Tubal patency after tubal catheterization procedure demonstrated by hysterosalpingo-foam sonography.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fallopian Obstruction Tube']}, 'referencesModule': {'references': [{'pmid': '34147190', 'type': 'BACKGROUND', 'citation': "Kohi MP. Interventional Radiologist's Approach to Fallopian Tube Recanalization. Tech Vasc Interv Radiol. 2021 Mar;24(1):100736. doi: 10.1016/j.tvir.2021.100736. Epub 2021 Apr 16."}, {'pmid': '33103116', 'type': 'BACKGROUND', 'citation': 'Wang JW, Rustia GM, Wood-Molo M, Tasse J, Tabriz D, Turba UC, Arslan B, Madassery S. Conception rates after fluoroscopy-guided fallopian tubal cannulation: an alternative to in vitro fertilization for patients with tubal occlusion. Ther Adv Reprod Health. 2020 Oct 8;14:2633494120954248. doi: 10.1177/2633494120954248. eCollection 2020 Jan-Dec.'}, {'pmid': '32979628', 'type': 'BACKGROUND', 'citation': 'Pyra K, Szmygin M, Dymara-Konopka W, Zych A, Sojka M, Jargiello T, Leszczynska-Gorzelak B. The pregnancy rate of infertile patients with proximal tubal obstruction 12 months following selective salpingography and tubal catheterization. Eur J Obstet Gynecol Reprod Biol. 2020 Nov;254:164-169. doi: 10.1016/j.ejogrb.2020.08.008. Epub 2020 Sep 16.'}, {'pmid': '28184438', 'type': 'BACKGROUND', 'citation': 'De Silva PM, Chu JJ, Gallos ID, Vidyasagar AT, Robinson L, Coomarasamy A. Fallopian tube catheterization in the treatment of proximal tubal obstruction: a systematic review and meta-analysis. Hum Reprod. 2017 Apr 1;32(4):836-852. doi: 10.1093/humrep/dex022.'}]}, 'descriptionModule': {'briefSummary': 'Investigate a novel ultrasound guided transcervical fallopian tube catheterization during hysterosalpingo-foam sonography in the treatment of proximal tubal obstruction.', 'detailedDescription': 'Tubal catheterization is usually reserved for infertility treatment in selected cases of proximal tubal occlusion. As the incidence of this condition is limited to approximately 10-20% of women with mechanical infertility, the hitherto published data concerning the best therapeutic approach for these patients is scarce.\n\nHysterolaparoscopy with dye instillation is considered the gold standard for comprehensive evaluation of the female reproductive organs. Moreover, while the gold standard for evaluation of the uterine cavity is diagnostic hysteroscopy and hydrosonography, tubal patency may be validated by either hystrosalpingography, or ultrasonic evaluation using Echovist-200. However, interpretation of the passage of contrast medium into the proximal portion of the tube remains somewhat uncertain.\n\nSince hysterolaparoscopy with dye instillation, is an expensive and an invasive procedure, with potentially life-threatening risks, the search for a safer and less invasive techniques is still ongoing. In 2012, Hysterosalpingo-Foam Sonography was introduced as a new technique for assessing fallopian tube patency. During the exam, the passage of a hyper-echogenic foam composed of a mixture of gel and purified water can be visualized as it progresses from the uterine cavity through the fallopian tubes into the peritoneal cavity. Hysterosalpingo-foam sonography is a promising alternative for laparoscopy and hysterosalpingography with regard to accuracy and effectiveness and has been suggested as a first step test of tubal assessment since it is relatively safe, non (embryo-) toxic and non-invasive.\n\nIn the present report the investigators aim to perform an ultrasound guided transcervical fallopian tube catheterization during hysterosalpingo-foam sonographyin the treatment of proximal tubal obstruction. This "one stop - shop" procedure combines uterine cavity investigation and assessment of tubal patency, with the concomitant advantage of therapeutic tubal re-canalization.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• uni or/and bilateral proximal tubal occlusion.\n\nExclusion Criteria:\n\n* ongoing pregnancy\n* positive Human Chorionic Gonadotropin test\n* active pelvic inflammatory disease\n* vaginal bleeding\n* presence of distal tubal occlusion'}, 'identificationModule': {'nctId': 'NCT05537805', 'acronym': 'HyFoSy', 'briefTitle': 'Ultrasound Guided Fallopian Tube Catheterization During Hysterosalpingo-foam Sonography (HyFoSy)', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Assaf-Harofeh Medical Center'}, 'officialTitle': 'Ultrasound Guided Transcervical Fallopian Tube Catheterization During Hysterosalpingo-foam Sonography in the Treatment of Proximal Tubal Obstruction', 'orgStudyIdInfo': {'id': '0275-21-ASF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'proximal tubal occlusion', 'description': 'Infertile patients that were referred to our unit for uni or bilateral proximal tubal occlusion demonstrated by HyFoSy or hysterosalpingography.', 'interventionNames': ['Procedure: Ultrasound guided transcervical fallopian tube catheterization during hysterosalpingo-foam sonography in the treatment of proximal tubal obstruction']}], 'interventions': [{'name': 'Ultrasound guided transcervical fallopian tube catheterization during hysterosalpingo-foam sonography in the treatment of proximal tubal obstruction', 'type': 'PROCEDURE', 'description': 'The intervention included the usage of the modified cornual cannulation set (COOK) which was inserted through cervical canal to uterine cavity, followed by fallopian tube irrigation with contrast foam (Ex-EM) during hysterosalpingo-foam sonography under ultrasonographic imaging.', 'armGroupLabels': ['proximal tubal occlusion']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assaf-Harofeh Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof', 'investigatorFullName': 'Yaakov Melcer', 'investigatorAffiliation': 'Assaf-Harofeh Medical Center'}}}}