Testicular Tissue Freezing for Children with Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Candace F. Granberg, M.D.

Age: < 18

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Mayo Clinic

Disqualifiers: Psychiatric conditions, Anesthesia risk, Gonadotoxic therapy, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This protocol is being designed to offer testicular tissue cryopreservation to male pediatric patients (0-17 years of age) with fertility threatening medical diagnoses or facing surgery, chemotherapy or radiation therapy that may cause loss of reproductive potential.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial investigators or your healthcare provider.

What data supports the effectiveness of the treatment Testicular tissue cryopreservation for children with cancer?

The research shows that testicular tissue cryopreservation is a feasible and safe option for preserving fertility in young boys with cancer, with a high acceptance rate among families. Although still experimental, the procedure has been successfully implemented in multiple centers, indicating its potential for future use.

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Is testicular tissue freezing safe for children with cancer?

Testicular tissue freezing has been studied in prepubertal and adolescent boys, and while it is considered experimental, it has shown to be generally safe with only minor adverse events reported that did not require medical treatment.

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How is testicular tissue freezing different from other treatments for preserving fertility in children with cancer?

Testicular tissue freezing is unique because it involves preserving immature testicular tissue before cancer treatment, allowing for potential fertility restoration after therapy. Unlike other methods, it is specifically designed for prepubertal boys who cannot produce sperm yet, offering a future option for fertility that other treatments do not provide.

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Eligibility Criteria

This trial is for boys aged 0-17 at risk of infertility due to medical treatments or conditions affecting the testicles. It's open to those with a high, intermediate, or low risk of prolonged azoospermia (no sperm), and those needing surgery that may impact fertility. Participants must have two testicles if they're having one removed just for preservation.

Inclusion Criteria

I have two testicles and am considering removal for fertility reasons.

I am at risk of losing my fertility due to treatment or a condition.

Sign informed consent and authorization for release of health information

Exclusion Criteria

I have received chemotherapy or radiation that could affect my fertility.

Diagnosed with conditions preventing informed consent

I am at high risk for complications from anesthesia and surgery.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Testicular tissue cryopreservation procedure is performed for fertility preservation

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week post-surgery and then yearly

1 visit (in-person) at 1 week, yearly visits thereafter

Participant Groups

The trial is studying the process of freezing testicular tissue in young males who are at risk of losing their reproductive potential due to cancer treatments or other medical interventions. The goal is to preserve future fertility by storing this tissue before it's damaged.

Group I: Testicular tissue Experimental Treatment 1 Intervention

Children faced with a fertility threatening diagnosis or treatment plan will be offered testicular tissue cryopreservation, particularly if pre-pubescent and without other options to preserve fertility.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Mayo Clinic in Rochester Rochester, MN

Who Is Running the Clinical Trial?

Mayo Clinic Lead Sponsor

References

1. England pubmed.ncbi.nlm.nih.gov

Comparison of conditions for cryopreservation of testicular tissue from immature mice. [2022] Cryopreservation of immature testicular tissue could be considered as a major step in fertility preservation for young boys with cancer. In the present study, eight different freezing protocols were evaluated in immature mice testis.

2. England pubmed.ncbi.nlm.nih.gov

An experimental protocol for fertility preservation in prepubertal boys recently diagnosed with cancer: a report of acceptability and safety. [2022] Gonadal damage is a consequence of therapy for pediatric malignancies. Prepubertal males have no semen or mature spermatozoa, posing a challenge for fertility preservation. Testicular tissue cryopreservation is a potential option but is still experimental. We report on a pilot protocol that offered testicular biopsy cryopreservation to families of prepubertal boys with newly diagnosed malignancy. The aims were to determine the acceptability and safety of this procedure.

3. United States pubmed.ncbi.nlm.nih.gov

Histology of Testicular Biopsies Obtained for Experimental Fertility Preservation Protocol in Boys with Cancer. [2018] Cryopreservation of testicular tissue with subsequent reimplantation after therapy has the potential to preserve fertility for prepubertal boys with cancer. We present the histology and feasibility of testicular tissue procurement for this novel approach.

4. Switzerland pubmed.ncbi.nlm.nih.gov

Testicular tissue cryopreservation for fertility preservation in prepubertal and adolescent boys: A 6 year experience from a Swiss multi-center network. [2023] Testicular tissue cryopreservation is the only option of fertility preservation in prepubertal boys. While it is considered experimental, since procedures to obtain mature spermatozoa from prepubertal testicular tissue are still under development, testicular tissue cryopreservation programs have emerged worldwide. Our aim was to study the feasibility and safety of a program of testicular tissue cryopreservation in prepubertal and adolescent boys facing gonadotoxic treatment in three University hospitals in Switzerland. Testicular tissue cryopreservation was accepted by 90% of families, with a total of 35 patients included. The average patient age was 8.5 years (range 7 months to 18.5 years). Malignancies were the most common diagnosis (31 patients, 88.6%) with 16 (45.7%) solid tumors and 15 (42.9%) hematological malignancies. Four (11.4%) patients had a benign condition. The main indication for testicular tissue cryopreservation was conditioning for hematologic stem cell transplantation (25 patients, 71.4%). Testicular tissue was cryopreserved according to the freezing protocol of Louvain Catholic University (Belgium), which includes either only immature testicular tissue freezing, or mature and immature testicular tissue freezing depending on the age of the patient and the presence or absence of haploid cells. The median number of spermatogonia per tubule cross-section was 2 (range 0-6) and spermatozoa were found in only one patient. Tumoral cells were found in one testicular biopsy of a leukemic patient. There were two minor adverse events and none of them required medical treatment or surgical revision. Five patients died during follow-up. Our data demonstrate the feasibility and safety of a program of testicular tissue cryopreservation coordinated by a multidisciplinary team of fertility preservation. Despite the experimental aspect of the procedure, the acceptation rate was high, which highlights the willingness of families and patients to participate in testicular tissue cryopreservation.

5. Iran pubmed.ncbi.nlm.nih.gov

Developmental Potential of Vitrified Mouse Testicular Tissue after Ectopic Transplantation. [2020] Cryopreservation of immature testicular tissue should be considered as an important factor for fertility preservation in young boys with cancer. The objective of this study is to investigate whether immature testicular tissue of mice can be successfully cryopreserved using a simple vitrification procedure to maintain testicular cell viability, proliferation, and differentiation capacity.

6. England pubmed.ncbi.nlm.nih.gov

Optimizing cryopreservation of human testicular tissue: comparison of protocols with glycerol, propanediol and dimethylsulphoxide as cryoprotectants. [2013] Cryopreservation of testicular tissue is an option in fertility preservation for pre-pubertal boys who will lose spermatogenic cells as a result of chemotherapy. We compared three different protocols and cryoprotectants in cryopreservation of testicular tissue.

7. England pubmed.ncbi.nlm.nih.gov

Cryopreservation of testicular tissue in young cancer patients. [2022] Cryopreservation of testicular tissue might benefit prepubertal boys who must undergo chemotherapy or radiotherapy. Cryopreservation of testicular tissue and testicular cells for intracytoplasmic sperm injection (ICSI) is feasible and widely applied. Testicular tissue from prepubertal boys can also be frozen, by applying techniques used with other tissues and with testicular tissue from adult men before ICSI. Good results have been obtained when propanediol is used as a cryoprotectant, but glycerol has also been used when freezing testicular tissue. Spermatogonia might also be isolated and cryopreserved as a cell suspension, though practical experience in humans is lacking. Transplantation of the frozen-thawed cells back to the testes after cancer treatment might result in restoration of spermatogenesis. Live offspring have been born to mice after transplantation of fresh, but not cryopreserved, testicular cells. Transplantation is technically feasible also in larger species, but to date no offspring have been born. Spermatogenesis in vitro would be an excellent option for boys with haematological malignancies who carry a risk of relapse after transplantation; however, at present the method is feasible only for the late stages of spermatogenesis.

8. England pubmed.ncbi.nlm.nih.gov

Assessment of the architecture and integrity of frozen-thawed testicular tissue from (pre)pubertal boys with cancer. [2022] Testicular tissue freezing is proposed for fertility preservation to (pre)pubertal boys with cancer before highly gonadotoxic treatment. Studies accurately comparing human (pre)pubertal testicular tissue quality before freezing and after thawing are exceptional. No study has reported this approach in a systematic manner and routine care.