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

Not Applicable

Recruiting

• Conditions: Childhood Cancer; Fertility Disorders
• Interventions: Procedure: testicular tissue biopsy

• Registration Number: NCT03180918
• Lead Sponsor: Gumy-Pause Fabienne

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2017-05-31
• Study First Submitted QC: 2017-06-07
• Study First Posted: 2017-06-08
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-01
• Last Update Posted: 2022-11-02
• Primary Completion: 2100-01
• Study Completion: 2100-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
testicular tissue cryopreservation	testicular tissue biopsy	-

Primary Outcome Measures

Name	Time	Method
Number of pediatric cancer patient who will undergo testicular tissue cryopreservation for fertility preservation	0-20 years

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Geneva University Hospitals; 🇨🇭 Geneva, Switzerland

UKBB; 🇨🇭 Basel, Switzerland

CHUV; 🇨🇭 Lausanne, Switzerland