Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2025-12-26 @ 4:16 AM
Study NCT ID:
NCT03180827
Status:
RECRUITING
Last Update Posted:
2022-11-02
First Post:
2017-05-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Female Fertility Preservation Using Ovarian Tissue Cryopreservation Before Highly Gonadotoxic Cancer Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2100-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-01', 'studyFirstSubmitDate': '2017-05-31', 'studyFirstSubmitQcDate': '2017-06-07', 'lastUpdatePostDateStruct': {'date': '2022-11-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2100-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of pediatric cancer patient who will undergo ovarian tissue cryopreservation for fertility preservation', 'timeFrame': '0-20 years'}], 'secondaryOutcomes': [{'measure': 'Incidence of complications related to the ovarian biopsy (safety)', 'timeFrame': '0-20 years', 'description': 'The safety will be assessed by recording the number of complications of the procedure (e.g. bleeding, infection)'}, {'measure': 'Comparison of biochemical markers', 'timeFrame': '0-20 years', 'description': 'Comparison of biochemical markers (e.g., FSH; LH, AMH, progesterone, oestradiol) between patients who undergo ovarian biopsy and controls'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Childhood Cancer', 'Fertility Disorders']}, 'descriptionModule': {'briefSummary': 'Background:\n\nDue to the remarkable improvement in treatments these last decades, long term survival can be expected in more than 80% of childhood cancer patients. Unfortunately, cancer treatments can be harmful to the gonads and can affect reproductive and endocrine functions. While loss of fertility is a major concern for most patients, only the experimental option of ovarian tissue cryopreservation can be proposed to prepubertal girls with a high risk of infertility. For pubertal patient, cryopreservation of mature oocytes after ovarian stimulation can be offered if oncological treatment debut can be delayed. As it is often not possible, ovarian tissue cryopreservation can also be offered.\n\nPrimary aims\n\n\\- To cryopreserve ovarian tissue of pre or peripubertal patient who will be receiving highly gonadotoxic oncological treatment.\n\nSecondary aims\n\n* To create a database in order to record clinical and biological follow-up data\n* To pool resources with Fertisave Registry\n* To create a research biobank for future research projects\n\nMulticentric study: HUG, CHUV'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '2 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pediatric pre ou peripubertal patient aged 2 months and older\n* Patient presenting high risk of infertility because of gonadotoxic treatments (i.e. high dose of alkylating agents, ovarian irradiation, total body irradiation)\n* Multidisciplinary team consensus in favour to proposition to cryopreserve ovarian tissue.\n\nExclusion Criteria:\n\n* Patient under the age of 2 months\n* Refusal of the patient and/or her parents\n* Treatments that are not highly gonadotoxic'}, 'identificationModule': {'nctId': 'NCT03180827', 'briefTitle': 'Female Fertility Preservation Using Ovarian Tissue Cryopreservation Before Highly Gonadotoxic Cancer Treatment', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Geneva'}, 'officialTitle': 'Female Fertility Preservation Using Ovarian Tissue Cryopreservation Before Highly Gonadotoxic Cancer Treatment', 'orgStudyIdInfo': {'id': 'PB_2017-00536 (15-073)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ovarian tissue cryopreservation', 'interventionNames': ['Procedure: ovarian tissue biopsy']}], 'interventions': [{'name': 'ovarian tissue biopsy', 'type': 'PROCEDURE', 'description': 'ovarian tissue biopsy during general anesthesia', 'armGroupLabels': ['ovarian tissue cryopreservation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1211', 'city': 'Geneva', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Fabienne Gumy-Pause, Dr', 'role': 'CONTACT', 'email': 'fabienne.gumypause@hcuge.ch'}], 'facility': 'Geneva University Hospitals', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}, {'city': 'Lausanne', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Maja Beck Popovic, Prof', 'role': 'CONTACT'}], 'facility': 'CHUV', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}], 'centralContacts': [{'name': 'Fabienne Gumy-Pause, Dr', 'role': 'CONTACT', 'email': 'fabienne.gumypause@hcuge.ch'}], 'overallOfficials': [{'name': 'Fabienne Gumy-Pause, Dr', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital, Geneva'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gumy-Pause Fabienne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Gumy-Pause Fabienne', 'investigatorAffiliation': 'University Hospital, Geneva'}}}}