Actively Recruiting
Cryopreservation of Prepubertal Testicular Tissue for Preservation of Fertility in Young Boys With Cancer
Led by University of Edinburgh · Updated on 2025-11-20
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Edinburgh
Lead Sponsor
U
University of Oxford
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying prepubertal boys with cancer who face a high risk of infertility due to their cancer treatments. This study focuses on freezing (cryopreserving) testicular tissue biopsies taken before treatment begins to preserve fertility for future use. The study also explores laboratory methods to understand and support the development of sperm cells from the stored tissue. The research is conducted at the University of Edinburgh with patients from the Royal Hospital for Children and Young People. The procedure involves taking a small biopsy from one testis before cancer therapy starts, usually coordinated with other planned surgeries to avoid extra anesthesia. The tissue is then cryopreserved using advanced freezing methods and stored securely for up to 55 years. Part of the tissue may be used for laboratory research to improve freezing techniques and to study germ cell development using in vitro culture and xenografting methods. Consent is obtained from guardians and patients when appropriate. Participants will be followed up regularly in oncology and endocrinology clinics to monitor growth, pubertal development, and testicular health through clinical exams, hormone blood tests, ultrasound scans, and measurement of testicular volume. Researchers will assess fertility and reproductive hormone levels once participants reach adulthood, typically at 18 years. The study also tracks the safety of the biopsy procedure and its effects on testicular function over time.
CONDITIONS
Brief Title
Cryopreservation of Prepubertal Testicular Tissue for Preservation of Fertility in Young Boys With Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pre- and peripubertal boys
- Scheduled to receive cancer treatment with 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 will not qualify if you...
- Participation would delay cancer treatment
- Too unwell to undergo the biopsy procedure
- Pre-existing testicular problems or prior testicular surgery (e.g., orchidopexy)
- Able to produce a semen sample for cryopreservation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 1 day
Participants undergo a testicular biopsy under general anaesthetic, typically coinciding with a planned procedure to avoid additional anaesthesia. Tissue is collected for cryopreservation and optional laboratory research.
1 visit (in-person)
Duration - Up to adulthood, typically 18 years
Participants are followed up in the Oncology clinic and later in the joint Oncology/Endocrinology 'Late Effects' clinic to monitor growth, pubertal development, testicular volume, and reproductive hormones. Follow-up includes clinical examinations, blood tests, and annual ultrasound assessments to monitor for effects of the biopsy and fertility status.
Visits every 3 months during childhood and puberty, then between 3 monthly and annually
Trial Site Locations
Total: 1 location
1
University of Edinburgh
Edinburgh, Lothian, United Kingdom, EH164TJ
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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