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NCT06063551Recruiting

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

Cryopreservation of Prepubertal Testicular Tissue for Preservation

Source: ClinicalTrials.gov · Last updated 20 Nov 2025

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
100 (estimated)
First submitted
17 Aug 2022
Start date
1 Apr 2016
Primary completion date
Apr 2061
Lead sponsor
University of Edinburgh
NCT number
NCT06063551

What you commit to

  • Study type: Interventional
  • Planned participants: 100
  • From 1 Apr 2016 to the primary completion date, Apr 2061
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Pre-existing testicular pathology/previous testicular surgery (eg orchidopexy)

Other

  • Participation in study would delay treatment
  • Too unwell to undergo the procedure
  • Able to produce a semen sample for cryopreservation

Who the study is looking for

  • 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

Age in the registry: 1 day to 18 years · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Edinburgh
Coordinator of this site? Confirm its status
EdinburghUnited KingdomRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.