NCT06063551 Cryopreservation of Prepubertal Testicular Tissue for Preservation of Fertility in Young Boys With Cancer
| NCT ID | NCT06063551 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Edinburgh |
| Condition | Fertility Disorders |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2016-04-01 |
| Primary Completion | 2061-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2016-04-01 with a primary completion date of 2061-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 & Investigator
Rod T Mitchell, MBChB
PRINCIPAL INVESTIGATOR
University of Edinburgh
Frequently Asked Questions
Who can join the NCT06063551 clinical trial?
This trial is open to male participants only, aged 1 Day or older, up to 18 Years, studying Fertility Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06063551 currently recruiting?
Yes, NCT06063551 is actively recruiting participants. Visit ClinicalTrials.gov or contact University of Edinburgh to inquire about joining.
Where is the NCT06063551 trial being conducted?
This trial is being conducted at Edinburgh, United Kingdom.
Who is sponsoring the NCT06063551 clinical trial?
NCT06063551 is sponsored by University of Edinburgh. The principal investigator is Rod T Mitchell, MBChB at University of Edinburgh. The trial plans to enroll 100 participants.