Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2026-03-01 @ 9:33 PM
Study NCT ID:
NCT03180918
Status:
RECRUITING
Last Update Posted:
2022-11-02
First Post:
2017-05-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Male Fertility Preservation Using Cryopreservation of Testicular Tissue 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': '2015-01', '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 testicular tissue cryopreservation for fertility preservation', 'timeFrame': '0-20 years'}], 'secondaryOutcomes': [{'measure': 'Incidence of complications related to the testicular 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, testicular atrophy)'}, {'measure': 'Comparison of biochemical markers', 'timeFrame': '0-20 years', 'description': 'Comparison of biochemical markers (e.g., FSH; LH, AMH; Inhibin B, SHBG and testosterone) between patients who undergo testicular 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, sperm cryopreservation should be offered to all pubertal male patients. For prepubertal boys, only the experimental option of testicular biopsy in order to cryopreserve testicular stem cells can be proposed.\n\nPrimary aims\n\n\\- To cryopreserve testicular tissue of prepubertal patient receiving highly gonadotoxic oncological treatment.\n\nSecondary aims\n\n* To cryopreserve testicular tissue after failure of sperm cryopreservation in pubertal patient with high risk of infertility\n* To create a database in order to record clinical and biological follow-up data\n* To create a research biobank for future research projects\n\nMulticentric study: HUG, CHUV, UKBB'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '3 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Prepubertal patients aged 3 months and older\n* Peri and pubertal patients after failure of sperm cryopreservation\n* Patients presenting high risk of infertility because of gonadotoxic treatments (i.e high dose of alkylating agents, testicular irradiation, total body irradiation).\n* Multidisciplinary team consensus in favour of proposition to cryopreserve testicular tissue\n\nExclusion Criteria:\n\n* Patients under the age of 3 months\n* Refusal of the patient and/or his parents\n* Treatments that are not highly gonadotoxic'}, 'identificationModule': {'nctId': 'NCT03180918', 'briefTitle': 'Male Fertility Preservation Using Cryopreservation of Testicular Tissue Before Highly Gonadotoxic Cancer Treatment', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Geneva'}, 'officialTitle': 'Male Fertility Preservation Using Cryopreservation of Testicular Tissue Before Highly Gonadotoxic Cancer Treatment', 'orgStudyIdInfo': {'id': 'PB_2016-01378'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'testicular tissue cryopreservation', 'interventionNames': ['Procedure: testicular tissue biopsy']}], 'interventions': [{'name': 'testicular tissue biopsy', 'type': 'PROCEDURE', 'description': 'testicular tissue biopsy during general anesthesia', 'armGroupLabels': ['testicular tissue cryopreservation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Basel', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Tamara Diesch-Furlanetto, Dr', 'role': 'CONTACT'}], 'facility': 'UKBB', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}, {'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, Dr', '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', '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'}}}}