Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2025-12-25 @ 8:21 PM
Study NCT ID:
NCT06775769
Status:
RECRUITING
Last Update Posted:
2025-11-25
First Post:
2024-12-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Endometrioma Sclerotherapy and Ovarian Preservation
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Ultra-sonographer'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomised control trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-24', 'studyFirstSubmitDate': '2024-12-12', 'studyFirstSubmitQcDate': '2025-01-09', 'lastUpdatePostDateStruct': {'date': '2025-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-01-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ovarian Reserve', 'timeFrame': '24 months', 'description': 'To determine the statistical difference in ovarian reserve pre- and post- treatment (as measured by serum AMH at 3, 6, 12 and 24 months and antral follicle count at 6, 12 and 24 months) in participants randomised to receive laparoscopic ethanol sclerotherapy or laparoscopic excision of endometrioma'}], 'secondaryOutcomes': [{'measure': 'Endometrioma recurrence', 'timeFrame': '24 monhts', 'description': 'To determine if laparoscopic ethanol sclerotherapy for ovarian endometrioma alters recurrence of ovarian endometrioma (as measured by TVUSS at 6, 12 and 24 months) as compared to laparoscopic excision of endometrioma'}, {'measure': 'Symptomatology', 'timeFrame': '24 monhts', 'description': 'To determine if laparoscopic ethanol sclerotherapy for ovarian endometrioma affects symptomatology (as recorded by EHP-30) as compared to laparoscopic excision of endometrioma at 3, 6, 12 and 24 months'}, {'measure': 'Inflammation', 'timeFrame': '24 monhts', 'description': 'To determine if laparoscopic ethanol sclerotherapy for ovarian endometrioma alters the inflammatory environment (as measured in blood at 3, 6, 12 and 24 months, and endometrial biopsy at 6 months) as compared to laparoscopic excision of endometrioma'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Endometrioma', 'Endometriosis', 'Sclerotherapy'], 'conditions': ['Endometrioma']}, 'descriptionModule': {'briefSummary': 'A randomised controlled trial assessing ovarian reserve after laparoscopic ethanol sclerotherapy of ovarian endometrioma compared to standard treatment of surgical excision of endometrioma.\n\nSecondary outcomes will include endometrioma recurrence, symptomatology and inflammatory environment.', 'detailedDescription': 'Participants with endometrioma(ta), identified on imaging, who are opting for surgical management of endometriosis will be randomly allocated to laparoscopic ethanol sclerotherapy of endometrioma or laparoscopic surgical excision of endometrioma(ta). Any concurrent endometriosis identified at surgery will be excised as per routine care.\n\nOvarian reserve will be assessed by serum anti-Mullarian hormone (AMH) and antral follicle count (AFC), recurrence will me assessed by transvaginal ultrasound, symptomatology will be assessed by EHP-30 questionnaires and changes in inflammation assessed in serum and endometrial biopsy.\n\nEach participant will be followed up for a total of 24 months from surgery.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female (XX genotype, assigned female at birth)\n* Age 18-40\n* Finding of suspected uni- or bi-lateral ovarian endometrioma(ta) of ≥ 2cm on TVUSS and/or pelvic MRI scan (TVUSS, a uni- or multi-locular ovarian cystic lesion with low level echoes and diffuse homogeneous ground glass appearance; MRI any of, ovarian lesion hyperintense T1 without loss of signal on T1 fat-suppressed images, hypointense T2 exhibiting shading sign and/or T2 dark spot sign, variable restricted diffusion on DWI)\n* Appropriate to be listed for laparoscopic excision of endometrioma (Endometrioma ≥2cm, pain symptoms attributable to endometriosis where medical management is unsuccessful or unacceptable to the patient, to facilitate ART)\n\nExclusion Criteria:\n\n* Postmenopausal status\n* Suspicion of malignancy\n* Unable to undergo TVUSS\n* Declines to take part in the study\n* Unable to understand verbal or written information in English\n* Lack of capacity to consent at the point of recruitment\n* Known safeguarding issues'}, 'identificationModule': {'nctId': 'NCT06775769', 'acronym': 'ENDOSAVE', 'briefTitle': 'Endometrioma Sclerotherapy and Ovarian Preservation', 'organization': {'class': 'OTHER', 'fullName': 'Chelsea and Westminster NHS Foundation Trust'}, 'officialTitle': 'Endometrioma Sclerotherapy and Ovarian Preservation: a Randomised Control Trial of Laparoscopic Sclerotherapy vs Traditional Excision of Endometrioma', 'orgStudyIdInfo': {'id': '24/LO/0825'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Surgical Management of Endometrioma', 'description': 'Routine Care', 'interventionNames': ['Procedure: Routine Care']}, {'type': 'EXPERIMENTAL', 'label': 'Laparoscopic Sclerotherapy', 'description': 'Laparoscopic ethanol sclerotherapy of endometrioma', 'interventionNames': ['Procedure: Sclerotherapy']}], 'interventions': [{'name': 'Sclerotherapy', 'type': 'PROCEDURE', 'description': 'Laparoscopic ethanol sclerotherapy of endometrioma', 'armGroupLabels': ['Laparoscopic Sclerotherapy']}, {'name': 'Routine Care', 'type': 'PROCEDURE', 'description': 'Routine surgical management of endometrioma', 'armGroupLabels': ['Surgical Management of Endometrioma']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SW10 9NH', 'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Gulsah Cetinkaya', 'role': 'CONTACT', 'email': 'gulsah.cetinkaya1@nhs.net', 'phone': '020 3315 6646'}], 'facility': 'Chelsea and Westminster NHS Foundation Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'Sarah Bennet, BSc MBBS MRCOG', 'role': 'CONTACT', 'email': 'sarah.bennet25@imperial.ac.uk', 'phone': '07983980924'}, {'name': 'Thomas Bainton, BM BCh MRCOG MA(Oxon)', 'role': 'CONTACT', 'email': 'tombainton@doctors.org.uk'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chelsea and Westminster NHS Foundation Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}