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

Studien-Informationen Einschlusskriterien Studien-Rationale Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT03180918

Studienbeginn:
Januar 2015

Letztes Update:
02.11.2022

Wirkstoff:
-

Geschlecht:
Männer

Altersgruppe:
Kinder (0-17)

Phase:
-

Sponsor:
Gumy-Pause Fabienne

Collaborator:
-

Studienleiter

Fabienne Gumy-Pause
Study Chair
University Hospital, Geneva

Kontakt

Fabienne Gumy-Pause, Dr
Kontakt:
E-Mail: fabienne.gumypause@hcuge.ch» Kontaktdaten anzeigen

Studienlocations
(3 von 3)

UKBB
Basel
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Tamara Diesch-Furlanetto, Dr» Ansprechpartner anzeigen

Geneva University Hospitals
1211 Geneva
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Fabienne Gumy-Pause, Dr
E-Mail: fabienne.gumypause@hcuge.ch» Ansprechpartner anzeigen

CHUV
Lausanne
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Maja Beck Popovic, Dr» Ansprechpartner anzeigen

Studien-Informationen

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

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. Number of pediatric cancer patient who will undergo testicular tissue cryopreservation for fertility preservation (Time Frame - 0-20 years)

Secondary outcome:

1. Incidence of complications related to the testicular biopsy (safety) (Time Frame - 0-20 years):
The safety will be assessed by recording the number of complications of the procedure (e.g. bleeding, infection, testicular atrophy)

2. Comparison of biochemical markers (Time Frame - 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

Geprüfte Regime

testicular tissue biopsy:
testicular tissue biopsy during general anesthesia

Quelle: ClinicalTrials.gov

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