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

NCT ID: NCT03180918

Last Updated: 2022-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2100-01-31

Brief Summary

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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

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Conditions

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Childhood Cancer Fertility Disorders

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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testicular tissue cryopreservation

Group Type EXPERIMENTAL

testicular tissue biopsy

Intervention Type PROCEDURE

testicular tissue biopsy during general anesthesia

Interventions

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testicular tissue biopsy

testicular tissue biopsy during general anesthesia

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

3 Months

Maximum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Gumy-Pause Fabienne

OTHER

Sponsor Role lead

Responsible Party

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Gumy-Pause Fabienne

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Fabienne Gumy-Pause

Role: STUDY_CHAIR

University Hospital, Geneva

Locations

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UKBB

Basel, , Switzerland

Site Status RECRUITING

Geneva University Hospitals

Geneva, , Switzerland

Site Status RECRUITING

CHUV

Lausanne, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Fabienne Gumy-Pause, Dr

Role: CONTACT

Facility Contacts

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Tamara Diesch-Furlanetto, Dr

Role: primary

Fabienne Gumy-Pause, Dr

Role: primary

Maja Beck Popovic, Dr

Role: primary

Other Identifiers

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PB_2016-01378

Identifier Type: -

Identifier Source: org_study_id

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