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

Sponsor

Gumy-Pause Fabienne (Other)

Overall Status

Recruiting

CT.gov ID

NCT03180918

Collaborator

(none)

100

Enrollment

Locations

Arm

1020

Anticipated Duration (Months)

33.3

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Childhood Cancer Fertility Disorders	Procedure: testicular tissue biopsy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jan 1, 2015

Anticipated Primary Completion Date :

Jan 1, 2100

Anticipated Study Completion Date :

Jan 1, 2100

Arms and Interventions

Arm	Intervention/Treatment
Experimental: testicular tissue cryopreservation	Procedure: testicular tissue biopsy testicular tissue biopsy during general anesthesia

Arm

Intervention/Treatment

Experimental: testicular tissue cryopreservation

Procedure: testicular tissue biopsy

testicular tissue biopsy during general anesthesia

Outcome Measures

Primary Outcome Measures

Number of pediatric cancer patient who will undergo testicular tissue cryopreservation for fertility preservation [0-20 years]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Months to 18 Years

Sexes Eligible for Study:

Male

Accepts 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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	UKBB	Basel	Switzerland
2	Geneva University Hospitals	Geneva	Switzerland	1211
3	CHUV	Lausanne	Switzerland

Sponsors and Collaborators

Gumy-Pause Fabienne

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gumy-Pause Fabienne, Principal Investigator, University Hospital, Geneva

ClinicalTrials.gov Identifier:

NCT03180918

Other Study ID Numbers:

PB_2016-01378

First Posted:

Jun 8, 2017

Last Update Posted:

Aug 9, 2021

Last Verified:

Aug 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Aug 9, 2021