Trial Summary
What is the purpose of this trial?The "Testicular Tissue Cryopreservation" study is open to a subset of patients facing disease or treatment regimens that could lead to infertility (gonadotoxic therapies). For some of these patients, experimental testicular tissue cryopreservation is the only fertility preservation option available. The overall objective of this study is to determine the feasibility and acceptability of testicular tissue cryopreservation in male patients of all ages who have a condition or will undergo a treatment that can cause infertility.
Is Testicular Tissue Cryopreservation a promising treatment for infertility?Yes, Testicular Tissue Cryopreservation is a promising treatment for infertility. It helps preserve fertility in boys who might lose their ability to produce sperm due to cancer treatments. This method involves freezing testicular tissue, which contains cells that can later develop into sperm. This preserved tissue can be used in the future to help these boys have children.125911
What data supports the idea that Testicular Tissue Freezing for Infertility is an effective treatment?The available research shows that Testicular Tissue Freezing can be a promising option for preserving fertility in prepubertal boys who cannot use other methods like sperm freezing. Studies have shown that this method can preserve the cells needed for future sperm production, and there have been successful cases in animals where live offspring were produced from frozen testicular tissue. However, more research is needed to confirm its effectiveness in humans.4561012
What safety data exists for testicular tissue freezing for infertility?The procedure of cryopreserving testicular tissue, particularly for pre-pubertal and adolescent boys at risk of infertility due to gonadotoxic treatments, is considered low risk with minimal morbidity and complications. However, the technology for using the preserved tissue is still unproven and requires further research. The process is experimental and involves counseling families about the risks and available fertility preservation strategies. In Germany, specific approvals are required for cryopreservation and use of testicular tissue.347813
Do I need to stop my current medications for the trial?The trial protocol does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Eligibility Criteria
This trial is for male patients of any age who may become infertile due to a medical condition or treatments that are harmful to reproductive cells. It's specifically aimed at those for whom freezing testicular tissue is the only option to preserve fertility.Inclusion Criteria
I am scheduled for treatment that may permanently affect my ability to produce sperm.
Exclusion Criteria
I have a health condition that makes anesthesia and surgery riskier for me.
Treatment Details
The study focuses on taking a small sample of testicular tissue and freezing it (cryopreservation) with the goal of preserving future fertility. The feasibility and acceptability of this procedure in patients at risk of infertility will be evaluated.
1Treatment groups
Experimental Treatment
Group I: Testicular Tissue CryopreservationExperimental Treatment1 Intervention
Enrolled participants will undergo a testicular tissue biopsy. The method and amount of tissue procurement will be at the discretion of the surgeon.
Testicular Tissue Cryopreservation is already approved in United States, European Union for the following indications:
๐บ๐ธ Approved in United States as Testicular Tissue Cryopreservation for:
- Experimental fertility preservation for prepubertal males facing gonadotoxic treatments or diseases
๐ช๐บ Approved in European Union as Testicular Tissue Cryopreservation for:
- Experimental fertility preservation for prepubertal males facing gonadotoxic treatments or diseases
Find a clinic near you
Research locations nearbySelect from list below to view details:
University of ColoradoAurora, CO
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Who is running the clinical trial?
University of Colorado, DenverLead Sponsor
References
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.
Methods of cryopreservation of testicular tissue with viable spermatogonia in pre-pubertal boys undergoing gonadotoxic cancer treatment. [2022]Banking of testicular tissue from pre-pubertal boys before gonadotoxic treatment is a crucial step in fertility preservation. We wanted to find optimal methods for cryopreservation of testicular tissue from pre-pubertal boys, modifying techniques developed for fetal and adult human testicular tissue cryopreservation.
Meiotic activity in orthotopic xenografts derived from human postpubertal testicular tissue. [2011]Grafting of frozen-thawed testicular tissue has been suggested as a novel fertility preservation method for patients undergoing gonadotoxic treatments. However, this technique still needs further optimization before any clinical application. So far, grafting of human testicular tissue has only been performed to the back skin of nude mice and has shown spermatogonial stem-cell survival and occasionally differentiation up to primary spermatocytes. In this study, orthotopic grafting to mouse testes was evaluated as an alternative, and the effect of freezing and the donor's age was studied.
What is the best cryopreservation protocol for human testicular tissue banking? [2022]Is there a better alternative to the conventional cryopreservation protocols for human testicular tissue banking?
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.
Experimental testicular tissue banking to generate spermatogenesis in the future: A multidisciplinary team approach. [2022]Spermatogonial stem cell (SSC) loss due to cancer treatment, developmental disorder or genetic abnormality may cause permanent infertility. Cryopreservation of ejaculated sperm is an effective method of fertility preservation in adult males at risk of infertility. However this is not an option in pre-pubertal boys because spermatogenesis has not yet started, and it is difficult in adolescents who are not sexually mature. Therefore testicular tissue cryopreservation to preserve SSCs for future generation of spermatogenesis, either in vivo or in vitro, could be an option for these groups of patients. Although SSC transplantation has been successful in several species including non-human primates, it is still experimental in humans. There are several remaining concerns which need to be addressed before initiating trials of human SSC autotransplantation. Establishment of a testicular tissue banking system is a fundamental step towards using SSC technology as a fertility preservation method. It is important to understand the consultation, harvesting the testicular tissue, histological evaluation, cryopreservation, and long term storage aspects. We describe here a multidisciplinary approach to establish testicular tissue banking for males at risk of infertility.
Cryopreservation of testicular tissue in pre-pubertal and adolescent boys at risk for infertility: A low risk procedure. [2019]Cryopreservation of testicular tissue (TT) has become an increasingly attractive option for fertility preservation (FP), particularly for pre-pubertal boys at risk for gonadotoxicity from cancer therapy. At our institution, all at-risk families undergo counseling regarding infertility risk and available FP strategies, including this vulnerable patient population. As the technology required to use the acquired tissue is, as yet, unproven, it is paramount to document minimal morbidity and complications from this procedure. Herein, we report these outcomes for all pre-pubertal patients who have undergone TT biopsies for FP.
Testicular wedge biopsy for fertility preservation in children at significant risk for azoospermia after gonadotoxic therapy. [2019]Testicular tissue cryopreservation (TTC) provides an experimental option for fertility preservation for male children at significant risk for azoospermia owing to high-risk gonadotoxic treatments.
Cryopreservation and Culture of Testicular Tissues: An Essential Tool for Biodiversity Preservation. [2021]Systematic cryo-banking of reproductive tissues could enhance reproductive management and ensure sustainability of rare mammalian genotypes. Testicular tissues contain a vast number of germ cells, including at early stages (spermatogonia and spermatocytes), that can potentially develop into viable spermatozoa after grafting or culture in vitro, and the resulting sperm cells then can be used for assisted reproductive techniques. The objective of this review was to describe current advances, limitations, and perspectives related to the use of testicular tissue preservation as a strategy for the conservation of male fertility. Testes can be obtained from mature or prepubertal individuals, immediately postmortem or by orchiectomy, but testicular biopsies could also be an alternative to collect samples from living individuals. Testicular fragments can be then cryopreserved by using slow or ultra-rapid freezing, or even vitrification methods. The composition of cryopreservation media can vary according to species-specific characteristics, especially regarding the cryoprotectant type and concentration. Finally, spermatozoa have been usually obtained after xenografting of testicular fragments into severely immunodeficient mice, while this method still has to be optimized after in vitro culture conditions.
Strategies for cryopreservation of testicular cells and tissues in cancer and genetic diseases. [2021]Cryopreservation of testicular cells and tissues is useful for the preservation and restoration of fertility in pre-pubertal males expecting gonadotoxic treatment for cancer and genetic diseases causing impaired spermatogenesis. A number of freezing and vitrification protocols have thus been tried and variable results have been reported in terms of cell viability spermatogenesis progression and the production of fertile spermatozoa. A few studies have also reported the production of live offspring from cryopreserved testicular stem cells and tissues in rodents but their replication in large animals and human have been lacking. Advancement in in vitro spermatogenesis system has improved the possibility of producing fertile spermatozoa from the cryopreserved testis and has reduced the dependency on transplantation. This review provides an update on various cryopreservation strategies for fertility preservation in males expecting gonadotoxic treatment. It also discusses various methods of assessing and ameliorating cryoinjuries. Newer developments on in vitro spermatogenesis and testicular tissue engineering for in vitro sperm production from cryopreserved SSCs and testicular tissue are also discussed.
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.
Freezing protocols for the cryopreservation of immature testicular tissue - a systematic review. [2022]Increasing numbers of childhood cancer survivors reach adulthood making therapy induced infertility a growing concern. Sperm cryopreservation is not possible prior to puberty. Testicular tissue cryopreservation has been proposed as an alternative fertility preservation method for prepubertal males but no standardised cryopreservation procedure for immature tissue has been agreed to date. Here we review the current literature of cryopreservation protocols to determine which method best preserves the morphology and function of immature testicular tissue; and to examine which tissue intervention, grafting or tissue culture, is mostly likely to restore fertility. Embase, Medline, and Web of Science were systematically searched using relevant MeSH headings and search terms for testis, cryopreservation, and fertility preservation. This systematic search returned 4748 unique entries which were screened for relevance. Eleven studies were found to be eligible and were included in the systematic review. We found that cryopreservation protocols differ in freezing rate and cryoprotectant media, the optimum combination of which for ITT has yet to be determined. Further investigations must be carried out to decipher which method best preserves tissue integrity and function and which application method is most likely to induce spermatogenesis.
[Fertility and fertility preservation in men]. [2023]Fertility preservation is of high importance for patients prior to treatment that can impair fertility. The individual risk of becoming infertile after a fertility-reducing therapy depends on the type and duration of therapy, surgical technique, dose and combination of gonadotoxic drugs or radiation applied, and individual predisposition. Cryopreservation of ejaculated sperm is the standard procedure for creating a fertility reserve in men. In cases of azoospermia or inability to obtain semen by masturbation, testicular sperm can be obtained by (micro-)testicular sperm extraction (TESE) and cryopreserved. In case of retrograde ejaculation, sperm collection can be attempted by rectal electrostimulation or after off-label administration of imipramine from postmasturbatory urine. The cryopreserved sperm can be stored permanently in the gaseous phase of liquid nitrogen before being used in fertility therapy. In Germany, approval according to ยง 20b of the German Medicines Act (AMG) is a mandatory requirement for performing cryopreservation of sperm and testicular tissue; approval according to ยง 20c of the AMG must be obtained for use. For prepubertal boys, it is possible to cryopreserve dormant spermatogonial stem cells as part of an experimental procedure.