Male Fertility Preservation Using Cryopreservation of Testicular Tissue Before Highly Gonadotoxic Cancer Treatment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: testicular tissue biopsy.
- Who it may be relevant to
- Registry conditions: Childhood Cancer, Fertility Disorders. Basic parameters: 3 months — 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
Interventions
- Procedure testicular tissue biopsy
testicular tissue biopsy during general anesthesia
Primary outcome measures
- Number of pediatric cancer patient who will undergo testicular tissue cryopreservation for fertility preservation [Time frame: 0-20 years]
Secondary outcome measures (2)
- Incidence of complications related to the testicular biopsy (safety) [Time frame: 0-20 years]
- Comparison of biochemical markers [Time frame: 0-20 years]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Patients under the age of 3 months
- Refusal of the patient and/or his parents
- Treatments that are not highly gonadotoxic
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Switzerland · 3 centers
- UKBB — Basel
- Geneva University Hospitals — Geneva
- CHUV — Lausanne
Identifiers
NCT: NCT03180918 · PB_2016-01378