Male Fertility Preservation Using Cryopreservation of Testicular Tissue Before Highly Gonadotoxic Cancer Treatment

Study Overview
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Brief Summary
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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

Official Title
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Male Fertility Preservation Using Cryopreservation of Testicular Tissue Before Highly Gonadotoxic Cancer Treatment

Conditions
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Childhood Cancer, Fertility Disorders

Intervention / Treatment
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* Procedure: testicular tissue biopsy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: testicular tissue cryopreservation<br> | Procedure: testicular tissue biopsy<br>* testicular tissue biopsy during general anesthesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of pediatric cancer patient who will undergo testicular tissue cryopreservation for fertility preservation |  | 0-20 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of complications related to the testicular biopsy (safety) | The safety will be assessed by recording the number of complications of the procedure (e.g. bleeding, infection, testicular atrophy) | 0-20 years | 
| Comparison of biochemical markers | Comparison of biochemical markers (e.g., FSH; LH, AMH; Inhibin B, SHBG and testosterone) between patients who undergo testicular biopsy and controls | 0-20 years |