Actively Recruiting

Phase Not Applicable
Age: 1Day - 18Years
MALE
NCT06063551

Cryopreservation of Prepubertal Testicular Tissue for Preservation of Fertility in Young Boys With Cancer

Led by University of Edinburgh · Updated on 2025-11-20

100

Participants Needed

1

Research Sites

2348 weeks

Total Duration

On this page

Sponsors

U

University of Edinburgh

Lead Sponsor

U

University of Oxford

Collaborating Sponsor

AI-Summary

What this Trial Is About

Prepubertal boys treated for cancer are at risk of infertility as a result of their treatment. At present there are no options to preserve fertility in these boys. With informed consent, the investigators aim to cryopreserve (freeze) testis tissue biopsies taken from boys undergoing cancer therapy with a high risk of infertility. A portion of cryopreserved tissue will be securely stored, which in the future may be used to restore fertility in the patients. A second portion of the tissue will be used for laboratory work aimed at understanding the conditions required for development of the germ cells. Patients will be recruited from the Oncology Department at the Royal Hospital for Children and Young People (RHCYP) in Edinburgh. Tissue will be obtained from prepubertal patients with cancer who are about to undergo treatment with a high risk (\>80%) of infertility. Informed consent will be obtained from the patients legal guardian (and patient if applicable) for the procedure and subsequent use of tissue. A testis biopsy from one testis will be performed and if possible will coincide with a planned routine procedure requiring general anaesthetic in order to avoid the need for additional anaesthesia. The procedure will take place at RHCYP during the initial assessment and prior to the commencement of cancer treatment and will not result in delay of treatment. Tissue will be assessed for the presence of sperm for storage using existing methods. In addition, tissue will be cryopreserved by Tissue and Cells Directorate, SNBTS in Edinburgh. The tissue will be stored for up to 55 years in accordance with current legislation (HFEA Act as amended 2005). Research will be carried out at the MRC Centre for Reproductive Health in accordance with Human Tissue (Scotland) Act 2006.

CONDITIONS

Official Title

Cryopreservation of Prepubertal Testicular Tissue for Preservation of Fertility in Young Boys With Cancer

Who Can Participate

Age: 1Day - 18Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Pre- and peripubertal boys
  • Due to receive cancer treatment that is predicted to have a high risk (>80%) of infertility
  • Consent to removal of testicular tissue for storage and research
  • Unable to produce a semen sample by masturbation
Not Eligible

You will not qualify if you...

  • Participation in study would delay treatment
  • Too unwell to undergo the procedure
  • Pre-existing testicular pathology/previous testicular surgery (eg orchidopexy)
  • Able to produce a semen sample for cryopreservation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Edinburgh

Edinburgh, Lothian, United Kingdom, EH164TJ

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

1

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