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NCT Number: NCT03180918

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

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

Recruiting

Interested in participating?

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Key information

Conditions

Childhood Cancer Fertility Disorders Neoplasms

Age range

3 month–18 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

UKBB, Basel, Switzerland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

testicular tissue biopsy

Procedure

testicular tissue biopsy during general anesthesia

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)

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Fabienne Gumy-Pause, Dr

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Gumy-Pause Fabienne

Other

Registry information

Important dates

Study start
2015
Primary completion
2100
Study completion
2100
First posted
Jun 8, 2017
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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