Cryopreservation of Prepubertal Testicular Tissue for Preservation

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 1 day
Maximum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
United Kingdom
University of Edinburgh
RECRUITING
Edinburgh
Time Frame
Start Date: 2016-04-01
Estimated Completion Date: 2061-04
Participants
Target number of participants: 100
Treatments
Experimental: Testicular Biopsy
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.
Related Therapeutic Areas
Sponsors
Leads: University of Edinburgh
Collaborators: University of Oxford

This content was sourced from clinicaltrials.gov