Health TrialsbyHealthPanel

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

ConditionsChildhood CancerFertility Disorders
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age3-18
SponsorGumy-Pause Fabienne

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patients under the age of 3 months

Refusal of the patient and/or his parents

Treatments that are not highly gonadotoxic

Trial design

Design model

Single group

Treatments tested in this trial

  • testicular tissue biopsy

    Procedure/Surgery

    testicular tissue biopsy during general anesthesia

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: testicular tissue cryopreservationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of pediatric cancer patient who will undergo testicular tissue cryopreservation for fertility preservation

Time frame
0-20 years

Secondary outcomes

1

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)

Time frame
0-20 years
2

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

Time frame
0-20 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Gumy-Pause Fabienne

Lead sponsor

University Hospital, Geneva

Sponsor institution

Source ClinicalTrials.gov
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