Male Fertility Preservation Using Cryopreservation of Testicular Tissue Before Highly Gonadotoxic Cancer Treatment
1 other identifier
interventional
100
1 country
3
Brief Summary
Background: Due 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. Primary aims \- To cryopreserve testicular tissue of prepubertal patient receiving highly gonadotoxic oncological treatment. Secondary aims
- To cryopreserve testicular tissue after failure of sperm cryopreservation in pubertal patient with high risk of infertility
- To create a database in order to record clinical and biological follow-up data
- To create a research biobank for future research projects Multicentric study: HUG, CHUV, UKBB
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2015
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
May 31, 2017
CompletedFirst Posted
Study publicly available on registry
June 8, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2100
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2100
November 2, 2022
November 1, 2022
85.1 years
May 31, 2017
November 1, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Number of pediatric cancer patient who will undergo testicular tissue cryopreservation for fertility preservation
0-20 years
Secondary Outcomes (2)
Incidence of complications related to the testicular biopsy (safety)
0-20 years
Comparison of biochemical markers
0-20 years
Study Arms (1)
testicular tissue cryopreservation
EXPERIMENTALInterventions
testicular tissue biopsy during general anesthesia
Eligibility Criteria
You may qualify if:
- Prepubertal patients aged 3 months and older
- Peri and pubertal patients after failure of sperm cryopreservation
- Patients presenting high risk of infertility because of gonadotoxic treatments (i.e high dose of alkylating agents, testicular irradiation, total body irradiation).
- Multidisciplinary team consensus in favour of proposition to cryopreserve testicular tissue
You may not qualify if:
- Patients under the age of 3 months
- Refusal of the patient and/or his parents
- Treatments that are not highly gonadotoxic
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
UKBB
Basel, Switzerland
Geneva University Hospitals
Geneva, 1211, Switzerland
CHUV
Lausanne, Switzerland
MeSH Terms
Conditions
Study Officials
- STUDY CHAIR
Fabienne Gumy-Pause
University Hospital, Geneva
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 31, 2017
First Posted
June 8, 2017
Study Start
January 1, 2015
Primary Completion (Estimated)
January 1, 2100
Study Completion (Estimated)
January 1, 2100
Last Updated
November 2, 2022
Record last verified: 2022-11