NCT06063551

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
425mo left

Started Apr 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress22%
Apr 2016Apr 2061

Study Start

First participant enrolled

April 1, 2016

Completed
6.4 years until next milestone

First Submitted

Initial submission to the registry

August 17, 2022

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

October 2, 2023

Completed
37.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2061

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2061

Last Updated

November 20, 2025

Status Verified

November 1, 2025

Enrollment Period

45 years

First QC Date

August 17, 2022

Last Update Submit

November 19, 2025

Conditions

Fertility DisordersChildhood Cancer

Outcome Measures

Primary Outcomes (2)

  • Assessment of fertility

    Semen analysis for sperm count

    On reaching adulthood, typically 18 years.

  • Reproductive hormones

    Measurement of reproductive hormones in blood

    On reaching adulthood, typically 18 years.

Secondary Outcomes (1)

  • Germ Cell Development

    2 years

Study Arms (1)

Testicular Biopsy

EXPERIMENTAL

Patients meeting eligibility criteria are offered experimental procedure of testicular biopsy for clinical storage and use in laboratory research. The intervention does not involve a drug or device.

Procedure: Testicular Biopsy

Interventions

Testicular BiopsyPROCEDURE

Testicular biopsy for clinical storage and laboratory research.

Testicular Biopsy

Eligibility Criteria

Age1 Day - 18 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsProject is on male fertility and therefore by definition is only applicable to males. Similar programmes are already established for females.
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Edinburgh

Edinburgh, Lothian, EH164TJ, United Kingdom

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Rod T Mitchell, MBChB

    University of Edinburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: The same protocol applies to all subjects.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2022

First Posted

October 2, 2023

Study Start

April 1, 2016

Primary Completion (Estimated)

April 1, 2061

Study Completion (Estimated)

April 1, 2061

Last Updated

November 20, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)