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

Gumy-Pause Fabienne

Status: Enrolling

Conditions: Fertility Disorders; Childhood Cancer

Treatments: Procedure: testicular tissue biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT03180918

PB_2016-01378

Details and patient eligibility

About

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

Enrollment: 100 estimated patients

Sex: Male

Ages: 3 months to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

testicular tissue cryopreservation

Experimental group

Treatment:

Procedure: testicular tissue biopsy