Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-27 @ 11:15 PM
Study NCT ID:
NCT07119060
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-12
First Post:
2025-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ablative Technique For Ovarian Preservation In Endometrioma
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': 'D015653', 'term': 'Cystectomy'}, {'id': 'D015911', 'term': 'Sclerotherapy'}], 'ancestors': [{'id': 'D013520', 'term': 'Urologic Surgical Procedures'}, {'id': 'D013519', 'term': 'Urogenital Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 332}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2035-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-11', 'studyFirstSubmitDate': '2025-07-23', 'studyFirstSubmitQcDate': '2025-08-11', 'lastUpdatePostDateStruct': {'date': '2025-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2034-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To compare pregnancy rates observed up to 24 months after surgery for endometriosis with endometrioma treatment', 'timeFrame': 'From enrollment to 24 months after the surgery', 'description': 'A Pregnancy is considered if the CGH is \\>1000 UI/L or a intra uterine pregnancy after 5 weeks of amenorrhea'}], 'secondaryOutcomes': [{'measure': 'To compare birth rates pregnancies', 'timeFrame': 'From enrollment to 24 months after the surgery'}, {'measure': 'To compare spontaneous pregnancy rates', 'timeFrame': 'From enrollment to 24 months after the surgery'}, {'measure': 'To compare pregnancies achieved through assisted reproductive technology (ART)', 'timeFrame': 'From enrollment to 24 months after the surgery'}, {'measure': 'To compare pregnancies progressing beyond 12 weeks of amenorrhea', 'timeFrame': 'From enrollment to 24 months after the surgery'}, {'measure': 'To compare the recurrence rate of endometriomas, defined as the appearance of an endometrioma larger than 2 cm on the same ovary.', 'timeFrame': 'From enrollment to 24 months after the surgery'}, {'measure': 'To compare postoperative complication rates', 'timeFrame': 'During 3 months after the surgery'}, {'measure': 'To compare pain scores using the Biberoglu and Behrman scale (Biberoglu and Behrman >4)', 'timeFrame': 'From enrollment to 24 months after the surgery', 'description': 'Pelvic pain will be assessed using the Biberoglu and Behrman scale, which evaluates pain in three domains: dysmenorrhea, dyspareunia, and pelvic pain on palpation. Each domain is scored from 0 (no pain) to 3 (severe pain), with a total score ranging from 0 to 9.\n\nHigher scores indicate more severe pain (i.e., a worse outcome). A score greater than 4 is considered clinically significant.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['surgery', 'endometrioma', 'endometriosis', 'kystectomy', 'sclerotherapy', 'plasma vaporization', 'fertility'], 'conditions': ['Endometrioma', 'Fertility']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to compare pregnancy rates after different surgical treatments for endometriomas in adult women who have one or more ovarian cysts (endometriomas) larger than 2 cm requiring surgery. The main questions it aims to answer are:\n\nHow many women become pregnant within 24 months after surgery ? What are the birth rates and different types of pregnancies (natural, with fertility treatments, and those continuing beyond 12 weeks)? How often do the endometriomas come back after surgery? What surgery-related complications occur? How do pain levels change after treatment?\n\nResearchers will compare different surgical treatment groups to see if one approach results in better pregnancy outcomes and fewer complications.\n\nParticipants will:\n\nBe randomly assigned to different surgical treatment groups Undergo surgery for their endometriomas and endometriosis Attend follow-up visits at 3 months and 24 months after the procedure Have their pregnancy outcomes, pain levels, and potential complications monitored throughout the study period'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '43 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient aged between 18 and 43 years (inclusive)\n* Patient diagnosed with endometriosis (by histology or imaging) and symptomatic, requiring surgery (pelvic pain and/or infertility and/or risk to an organ)\n* Pelvic MRI or ultrasound performed within the last year showing at least one endometrioma larger than 20 mm in diameter\n* Patient with an intention to conceive (probable or certain) after surgery\n* Patient informed and having signed the consent form\n* Patient covered by a social security scheme\n\nExclusion Criteria:\n\n* Intraoperative finding that the cyst is not an endometrioma\n* Patient under guardianship, conservatorship, or incapable of giving consent\n* Patient without sufficient understanding of the French language\n* Patient under judicial protection measures\n* Patient who is pregnant or breastfeeding'}, 'identificationModule': {'nctId': 'NCT07119060', 'acronym': 'ATOPE', 'briefTitle': 'Ablative Technique For Ovarian Preservation In Endometrioma', 'organization': {'class': 'OTHER', 'fullName': 'Clinique Tivoli Ducos'}, 'officialTitle': 'Monocentric, Controlled, Randomized Trial: Comparison of Pregnancy Rates in Women With One or More Endometriomas, Treated by Cystectomy, Plasma Vaporization, or Sclerotherapy', 'orgStudyIdInfo': {'id': 'CliTiv-01-2025'}, 'secondaryIdInfos': [{'id': '2024-A01400-47', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'cystectomy', 'description': 'Surgical removal of the endometrioma by gently pulling the cyst wall away from the ovarian tissue (divergent traction technique)', 'interventionNames': ['Procedure: Cystectomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'vaporization with plasma', 'description': 'It consists of destroying the cyst wall (vaporization) using plasma energy.', 'interventionNames': ['Procedure: plasma vaporization']}, {'type': 'OTHER', 'label': 'sclerotherapy', 'description': 'Ethanol sclerotherapy destroys the endometriotic tissue lining the inner wall of the cyst through prolonged contact with 96% ethanol.', 'interventionNames': ['Procedure: Sclerotherapy']}], 'interventions': [{'name': 'Cystectomy', 'type': 'PROCEDURE', 'description': 'Surgical removal of the endometrioma by gently pulling the cyst wall away from the ovarian tissue (divergent traction technique)', 'armGroupLabels': ['cystectomy']}, {'name': 'plasma vaporization', 'type': 'PROCEDURE', 'description': 'It consists of destroying the cyst wall (vaporization) using plasma energy', 'armGroupLabels': ['vaporization with plasma']}, {'name': 'Sclerotherapy', 'type': 'PROCEDURE', 'description': 'Ethanol sclerotherapy destroys the endometriotic tissue lining the inner wall of the cyst through prolonged contact with 96% alcohol', 'armGroupLabels': ['sclerotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33000', 'city': 'Bordeaux', 'country': 'France', 'contacts': [{'name': 'Clotilde HUET', 'role': 'CONTACT', 'email': 'recherche@ifemendo.fr', 'phone': '+33 7 85 30 63 45'}, {'name': 'Kristina ANANIAN', 'role': 'CONTACT', 'email': 'arc@ifemendo.fr', 'phone': '+33 6 50 13 92 54'}, {'name': 'Adrien CRESTANI', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Paul Henri GOUALARD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Thomas DENNIS', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Benjamin MERLOT', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Horace ROMAN', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'IFEMEndo - Clinique Tivoli', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}], 'centralContacts': [{'name': 'Clotilde HUET', 'role': 'CONTACT', 'email': 'recherche@ifemendo.fr', 'phone': '+33 7 85 30 63 45'}, {'name': 'Kristina ANANIAN', 'role': 'CONTACT', 'email': 'arc@ifemendo.fr', 'phone': '+33 6 50 13 92 54'}], 'overallOfficials': [{'name': 'Horace ROMAN', 'role': 'STUDY_DIRECTOR', 'affiliation': 'IFEMEndo - Clinique Tivoli'}, {'name': 'Adrien CRESTANI', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IFEMEndo - Clinique Tivoli'}]}, 'ipdSharingStatementModule': {'timeFrame': 'The data will be available beginning 12 months after publication of the primary results, for a period of 3 years.', 'ipdSharing': 'YES', 'description': 'IPD that underlie the results reported in this study (after de-identification) will be shared.', 'accessCriteria': 'Data will be shared with researchers who provide a methodologically sound proposal and whose aims are compatible with the original study objectives'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clinique Tivoli Ducos', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}