Testicular Tissue Freezing for Children with Cancer

Overseen By Asma Chattha, MBBS

Age: < 18

Sex: Male

Trial Phase: Academic

Sponsor: Mayo Clinic

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

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 1 day

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a method to help boys at risk of losing fertility due to cancer treatments or certain medical conditions. It offers a process called testicular tissue freezing (or testicular tissue cryopreservation) to preserve their future ability to have children. Suitable candidates include boys undergoing treatments like chemotherapy or surgery that could harm fertility, or those with conditions affecting reproductive health. Participants must have at least one testicle and be able to provide informed consent. As an unphased trial, this study presents a unique opportunity to contribute to groundbreaking research that could protect future fertility for many.

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 prior data suggests that this protocol is safe for children?

Research has shown that freezing testicular tissue safely preserves fertility in young boys. Studies have found that this method stores tissue effectively without causing harm. It is primarily used for boys who cannot yet produce sperm but require treatments that might impact future fertility. Although still considered experimental, no major health risks have been reported. Current evidence indicates that the procedure is generally well-tolerated in children. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about testicular tissue cryopreservation because it offers a fertility preservation option for children with cancer, especially those who are pre-pubescent and have no other choices. Unlike sperm banking, which is suitable only for post-pubescent boys, this method allows even young boys to potentially preserve their fertility. By freezing and storing testicular tissue, there's a hope that these children can use this tissue in the future to have biological children, which is a significant advancement in fertility preservation options for this age group.

What evidence suggests that testicular tissue cryopreservation is effective for preserving fertility in children with cancer?

Research has shown that freezing testicular tissue, a procedure participants in this trial will undergo, safely and effectively preserves fertility in children. Studies have found that this procedure can successfully save the cells needed for future reproduction. This method is particularly beneficial for boys undergoing cancer treatments that might impact their future fertility. Although still under investigation, it offers hope for preserving fertility in young patients. The procedure has been tested in both animals and humans, with promising results. ^{2 3 4 5 6}

Who Is on the Research Team?

Candace F. Granberg, MD

Principal Investigator

Mayo Clinic in Rochester

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Testicular tissue cryopreservation

Trial Overview 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.

How Is the Trial Designed?

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.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

A study involving 34 boys at risk of fertility loss due to cancer treatment showed that most had normal or increased germ cell counts in their testicular tissue, indicating potential for fertility preservation through cryopreservation.

However, abnormal maturation of germ cells was observed in some older patients, suggesting that further research is needed to understand the implications for fertility preservation in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Histology of Testicular Biopsies Obtained for Experimental Fertility Preservation Protocol in Boys with Cancer. Pietzak, EJ., Tasian, GE., Tasian, SK., et al.[2018]

A pilot study involving 21 families of prepubertal boys with newly diagnosed malignancies found that 76% consented to testicular biopsy cryopreservation, indicating strong acceptability among parents for this fertility preservation option.

The procedure was performed safely, with 14 out of 16 boys undergoing the biopsy experiencing no negative intraoperative or post-operative effects, suggesting that testicular tissue cryopreservation is a viable option for preserving fertility in this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An experimental protocol for fertility preservation in prepubertal boys recently diagnosed with cancer: a report of acceptability and safety. Ginsberg, JP., Carlson, CA., Lin, K., et al.[2022]

Testicular tissue cryopreservation is a feasible and safe option for fertility preservation in prepubertal and adolescent boys undergoing gonadotoxic treatments, with a high acceptance rate of 90% among families in a study involving 35 patients.

The procedure was primarily used for patients with malignancies, particularly those preparing for hematologic stem cell transplantation, and while spermatozoa were found in only one patient, the overall safety profile was good with only two minor adverse events reported.

NCBI (Pubmed)

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. Moussaoui, D., Surbone, A., Adam, C., et al.[2023]

Cryopreservation of immature testicular tissue using a simple vitrification procedure successfully maintained cell viability and tissue function, showing no significant difference in recovery rates compared to fresh tissue.

The study demonstrated that vitrified testicular tissue could differentiate into secondary spermatocytes and exhibited similar levels of cell proliferation and apoptosis as fresh tissue, indicating its potential for fertility preservation in young boys with cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developmental Potential of Vitrified Mouse Testicular Tissue after Ectopic Transplantation. Yamini, N., Pourmand, G., Amidi, F., et al.[2020]

In a study involving 87 (pre)pubertal boys with cancer, a control slow freezing protocol was found to effectively preserve the architecture and integrity of testicular tissue after thawing, with minimal cryodamage observed.

The number of spermatogonia and the expression of DNA repair markers remained stable post-thawing, indicating that the freezing process does not significantly impact the potential for future fertility preservation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of the architecture and integrity of frozen-thawed testicular tissue from (pre)pubertal boys with cancer. Rives-Feraille, A., Liard, A., Bubenheim, M., et al.[2022]

Cryopreservation of testicular tissue is a promising option for prepubertal boys undergoing cancer treatments, allowing for potential restoration of fertility after therapy.

While techniques for freezing and transplanting testicular tissue have shown success in animal studies, practical applications in humans are still limited, and no live offspring have been born from cryopreserved testicular cells yet.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cryopreservation of testicular tissue in young cancer patients. Hovatta, O.[2022]

In a study involving testicular tissue from 16 infertile men, DMSO was found to be the most effective cryoprotectant, preserving 70% of the seminiferous tubules' structure after freezing, compared to only 37% with 1,2-propanediol and severe damage with glycerol.

The research indicates that DMSO not only maintains the structural integrity of spermatogonia but also preserves the function of Leydig cells, which continue to release testosterone after cryopreservation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing cryopreservation of human testicular tissue: comparison of protocols with glycerol, propanediol and dimethylsulphoxide as cryoprotectants. Keros, V., Rosenlund, B., Hultenby, K., et al.[2013]

Cryopreservation of immature testicular tissue using 1.5 M DMSO with a controlled slow protocol without seeding (CS-) was found to be the most effective method, preserving tissue architecture and cell viability after thawing.

This method not only maintained testosterone production and tubule growth similar to fresh samples but also provides a reliable way to evaluate cryodamage, which could be useful for future human applications in fertility preservation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of conditions for cryopreservation of testicular tissue from immature mice. Milazzo, JP., Vaudreuil, L., Cauliez, B., et al.[2022]

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0022346825002350

A Report on Testicular Tissue Cryopreservation for Fertility ... Conclusions. Testicular tissue cryopreservation is a safe and effective procedure for fertility preservation in the pediatric population. Germ cells were ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5099994/

Cryopreservation of testicular tissue or ... - PubMed Central This review gives an overview of existing cryopreservation protocols used in different animal models and humans.

3. jpedsurg.org jpedsurg.org/article/S0022-3468(25)00235-0/abstract

A Report on Testicular Tissue Cryopreservation for Fertility ... Testicular tissue cryopreservation is a safe and effective procedure for fertility preservation in the pediatric population. Germ cells were ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06063551

Cryopreservation of Prepubertal Testicular Tissue for ... With informed consent, the investigators aim to cryopreserve (freeze) testis tissue biopsies taken from boys undergoing cancer therapy with a high risk of ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40449728/

A Report on Testicular Tissue Cryopreservation for Fertility ... Conclusions: Testicular tissue cryopreservation is a safe and effective procedure for fertility preservation in the pediatric population.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9485727/

Testicular tissue cryopreservation for fertility preservation in ... Testicular tissue cryopreservation is the only option of fertility preservation in prepubertal boys. While it is considered experimental, since procedures ...