Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2026-01-01 @ 6:10 PM
Study NCT ID:
NCT06971458
Status:
RECRUITING
Last Update Posted:
2025-05-14
First Post:
2023-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endometrioma Ethanol Sclerotherapy - Prospective Cohort Study Protocol
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004715', 'term': 'Endometriosis'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015911', 'term': 'Sclerotherapy'}], 'ancestors': [{'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-08-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-06', 'studyFirstSubmitDate': '2023-03-07', 'studyFirstSubmitQcDate': '2025-05-06', 'lastUpdatePostDateStruct': {'date': '2025-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The effect of', 'timeFrame': '3 Years', 'description': 'ultrasound (US)-guided sclerotherapy for the treatment of ovarian endometrioma effect on ovarian function and fertility treatment outcome.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['IVF', 'Endometrioma']}, 'descriptionModule': {'briefSummary': 'Ovarian endometriomas are cystic masses lined with endometrial tissue that contains fluid arising from a collection of menstrual debris. Ovarian endometriomas clinical manifestations includes pelvic pain, dysmenorrhea, dysfunctional uterine bleeding, and infertility.\n\nEndometriomas are most commonly treated either medically or by surgical excision.\n\nUltrasonography (US)-guided aspiration and sclerotherapy is a new approach. Its mechanism of action is believed to be destruction of the inner epithelial lining, which is followed by inflammation and fibrosis, eventually resulting in regression of the cyst. The main advantage in this approach is the avoidance of collateral damage to the ovary.', 'detailedDescription': 'Endometriosis is a disease of the female reproductive system in which cells similar to those in the endometrium grow outside the uterus. Endometriosis prevalence is estimated to be around 10%, and even higher among women with infertility.\n\nEndometriosis can involve any pelvic organ and in rare cases it may also occur in other parts of the body.\n\nOvarian endometriomas are cystic masses lined with endometrial tissue that contains fluid arising from a collection of menstrual debris. Ovarian endometriomas clinical manifestations includes pelvic pain, dysmenorrhea, dysfunctional uterine bleeding, and infertility.\n\nEndometriomas are most commonly treated either medically or by surgical excision. Surgical excision is considered the standard therapy when pain is not controlled well by medication or when malignancy is being suspected. However, deterioration in the ovarian reserve after cystectomy is inevitable due to the removal of normal ovarian tissue adjacent to the endometrioma, and the possibility of excessive electrocoagulation for hemostasis.\n\nUltrasonography (US)-guided aspiration and sclerotherapy is a new approach. Its mechanism of action is believed to be destruction of the inner epithelial lining, which is followed by inflammation and fibrosis, eventually resulting in regression of the cyst. The main advantage in this approach is the avoidance of collateral damage to the ovary. There are still no guidelines suggesting US-guided sclerotherapy for endometrioma, although it has been used worldwide over the years since its introduction, and is reported to be an effective therapeutic option for endometriosis-associated pain and infertility. There are several reports of a higher oocyte number and higher pregnancy rate in IVF treatments after sclerotherapy in comparison with IVF after cystectomy. There is also a report of higher pregnancy rate in IVF treatments after sclerotherapy in comparison with leaving the endometrioma in-situ.\n\nThe procedure is done in an ambulatory arrangement under general anesthesia. Antibiotic prophylaxis with cefazolin 2g is administrated before beginning of the procedure. First step is (US)-guided aspiration of the endometrioma content. A sample of the aspirated content is sent to cytology test. Second, the cyst is flushed with normal saline. Third, the cyst is filled with 95% ethanol. The ethanol is suspended for 10-15 minutes inside the cyst capsule and then aspirated'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '41 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A woman with endometrioma with a diameter of 25-100 mm who is intended for IVF treatment to achieve pregnancy or for medical preservation/by choice.', 'genderDescription': 'Females only', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nA woman with endometrioma with a diameter of 25-100 mm\n\nExclusion Criteria:\n\n* Other causes of infertility (sperm disorder, ovulation disorder, uterine disorder, mechanical factor, poor ovarian reserve)'}, 'identificationModule': {'nctId': 'NCT06971458', 'briefTitle': 'Endometrioma Ethanol Sclerotherapy - Prospective Cohort Study Protocol', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hillel Yaffe Medical Center'}, 'officialTitle': 'Endometrioma Ethanol Sclerotherapy and Its Effect on Ovarian Function and Fertility Treatment Outcome - Prospective Cohort Study Protocol', 'orgStudyIdInfo': {'id': '0008-22-HYMC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'women with endometrioma size of 25-100 mm', 'description': 'Prospective cohort study including women with endometrioma size of 25-100 mm who will undergo ultrasound (US)-guided sclerotherapy. IVF treatment can be done about a month afterwards.', 'interventionNames': ['Procedure: Sclerotherapy']}], 'interventions': [{'name': 'Sclerotherapy', 'type': 'PROCEDURE', 'description': 'ultrasound (US)-guided sclerotherapy for the treatment of ovarian endometrioma', 'armGroupLabels': ['women with endometrioma size of 25-100 mm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hadera', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Osnat Palgi', 'role': 'CONTACT', 'email': 'osnatp@hymc.gov.il', 'phone': '+972-4-7744602'}], 'facility': 'Hillel Yaffe Medical Center', 'geoPoint': {'lat': 32.44192, 'lon': 34.9039}}], 'centralContacts': [{'name': 'Einat Shalom-Paz, Prof', 'role': 'CONTACT', 'email': 'EINATS@hymc.gov.il', 'phone': '+972-4-7744750'}, {'name': 'Osnat Palgi', 'role': 'CONTACT', 'email': 'osnatp@hymc.gov.il', 'phone': '+972-4-7744602'}], 'overallOfficials': [{'name': 'Einat Shalom-Paz, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hillel Yaffe Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hillel Yaffe Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}