Male Fertility Preservation Using Cryopreservation of Tes... | NCT03180918

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

NCT03180918

Sponsor

Gumy-Pause Fabienne

Status

Recruiting

Last Update Posted

May 27, 2026Actual

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Childhood Cancer
Fertility Disorders

Interventions

testicular tissue biopsy

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2015Actual

Primary Completion Date

Jan 2100Estimated

Completion Date

Jan 2100Estimated

First Submitted Date

May 31, 2017

First Submission Date that Met QC Criteria

Jun 7, 2017

First Posted Date

Jun 8, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 21, 2026

Last Update Posted Date

May 27, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
testicular tissue cryopreservation	Experimental		Procedure: testicular tissue biopsy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
testicular tissue biopsy	Procedure	testicular tissue biopsy during general anesthesia	testicular tissue cryopreservation

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Months

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Fabienne Gumy-Pause, Dr	Contact			fabienne.gumypause@hcuge.ch

Overall Officials

Name	Affiliation	Role
Fabienne Gumy-Pause	University Hospital, Geneva	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UKBB	Recruiting	Basel			Switzerland

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided