Clinical trial · Interventional
Cryopreservation of Prepubertal Testicular Tissue for Preservation of Fertility in Young Boys With Cancer
Cryopreservation of Prepubertal Testicular Tissue for Preservation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Childhood Cancer | Childhood Malignant Neoplasm | ALIAS | 0.90 |
| Fertility Disorders | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Testicular Biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Testicular Biopsy
- description
- 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.
- interventionNames
- Procedure: Testicular Biopsy
Primary outcomes (2)
- measure
- Assessment of fertility
- timeFrame
- On reaching adulthood, typically 18 years.
- description
- Semen analysis for sperm count
- measure
- Reproductive hormones
- timeFrame
- On reaching adulthood, typically 18 years.
- description
- Measurement of reproductive hormones in blood
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 1 Day
- Maximum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available