Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2026-03-01 @ 10:06 AM
Study NCT ID:
NCT03823833
Status:
COMPLETED
Last Update Posted:
2025-12-23
First Post:
2019-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oocyte Freezing for Fertility Preservation in Benign Ovarian Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004715', 'term': 'Endometriosis'}, {'id': 'D003884', 'term': 'Dermoid Cyst'}, {'id': 'D009078', 'term': 'Mucocele'}, {'id': 'D010048', 'term': 'Ovarian Cysts'}], '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'}, {'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D013724', 'term': 'Teratoma'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 82}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-04-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-16', 'studyFirstSubmitDate': '2019-01-28', 'studyFirstSubmitQcDate': '2019-01-28', 'lastUpdatePostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of mature oocytes eligible for cryopreservation', 'timeFrame': 'After 15 days of controlled ovarian hyperstimulation (COH)'}], 'secondaryOutcomes': [{'measure': 'Percentage of immature or morphologically abnormal oocytes', 'timeFrame': 'Real-time, the day of egg retrieval'}, {'measure': 'Number of mature follicles (≥15 mm) and intermediary (10-14 mm) during ovarian stimulation', 'timeFrame': 'The day of HCG triggering at the end of ovarian stimulation'}, {'measure': 'Questionnaire on tolerance and complications', 'timeFrame': 'One week after the egg retrieval', 'description': 'A systematic telephone interview will be carried out 48 to 72 hours after the oocyte puncture to judge the tolerance of the procedure.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Oocyte freezing', 'fertility preservation', 'ovarian cysts', 'benign ovarian tumor', 'endometrioma'], 'conditions': ['Endometriosis', 'Dermoid Cyst', 'Mucinous Cyst']}, 'descriptionModule': {'briefSummary': "Benign ovarian cysts are frequent during women's life. They are diagnosed with pelvic pain or fortuitously during an ultra-sonographic exam. In case of persistence,a surgery will be necessary to identify the nature of the cyst and assess its benignity. In some case, cysts are recurrent and multiple surgeries are needed leading to a significant risk of ovarian damage by follicular depletion. Oocyte cryopreservation is no longer considered as an experimental technique of Fertility Preservation since 2013 as it has been recognized to be efficient and safe. According to reproductive medicine scientific committees and the French ethic law, fertility preservation has to be proposed in every situation of infertility risk. To date, there is no cohort study dedicated to fertility preservation by oocyte freezing in this specific subgroup of patients. The purpose of the study is to prospectively evaluate the oocyte number and quality after controlled ovarian hyperstimulation in patients with recurrent ovarian cysts."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Young women with benign ovarian tumors and high risk of further infertility due to surgery', 'genderDescription': 'young women', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* women with benign ovarian tumor with high risk of recurrence, i-e, endometrioma, dermoid cysts or mucinous cysts.\n* women with previous surgery and/or high risk of ovarian damage: bilateral cysts, cyst diameter higher than 5 cms\n* Having a social insurance\n* Able to give an informed consent\n\nExclusion Criteria:\n\n* Borderline tumors\n* Undetectable AMH levels\n* Personal history of thrombo-embolic events\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT03823833', 'acronym': 'OFBOT', 'briefTitle': 'Oocyte Freezing for Fertility Preservation in Benign Ovarian Tumors', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': 'Systematic Proposal of Fertility Preservation by Oocyte Freezing in Case of Benign Ovarian Tumors With High Risk of Recurrence', 'orgStudyIdInfo': {'id': '2018_48'}}, 'contactsLocationsModule': {'locations': [{'zip': '59037', 'city': 'Lille', 'country': 'France', 'facility': 'Hop Jeanne de Flandre Chu Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'overallOfficials': [{'name': 'Christine Decanter, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Lille'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Lille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}