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

Childhood Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03180918
• Other study ID #: PB_2016-01378
• Status: Recruiting
• Phase: N/A
• Start date: January 2015
• Est. completion date: January 2100

Study information

• Verified date: November 2022
• Source: University Hospital, Geneva
• Contact: Fabienne Gumy-Pause, Dr
• Email: fabienne.gumypause[@]hcuge.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 2100
• Est. primary completion date: January 2100
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 3 Months to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Childhood Cancer
• Fertility Disorders

Intervention

Procedure:
• testicular tissue biopsy
testicular tissue biopsy during general anesthesia

Locations

Country	Name	City	State
Switzerland	UKBB	Basel
Switzerland	Geneva University Hospitals	Geneva
Switzerland	CHUV	Lausanne

Sponsors (1)

Lead Sponsor	Collaborator
Gumy-Pause Fabienne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of pediatric cancer patient who will undergo testicular tissue cryopreservation for fertility preservation		0-20 years
Secondary	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
Secondary	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