Testicular Tissue Cryopreservation for Fertility Preservation
Phase: Recruiting
Condition(s): Cancer
NCT Number: NCT02972801 Other Study ID Number(s): Testicular Cryo
What Is the Purpose of This Study?
This clinical trial will have separate portions of the harvested testicular tissues and/or derivative cells designated for research and for cryopreservation for a resource for future elective procedures to attempt fertility restoration. The portion designated for research will be used to:
- Optimize conditions for shipping, cryopreserving, and thawing testicular tissue
- Determine presence of germ cells in the patients' testicular tissue
- Learn the impact of diseases or medical treatments on testicular morphology and function
- Develop next generation reproductive technologies to treat infertility
Who Can Take Part in This Study?
People who may be eligible for this study:
- Must have two testes.
- Can be any age.
- Are scheduled to undergo surgery, chemo, drug treatment, and/or radiation for treatment or prevention of a medical condition or malignancy with risk of causing permanent and complete loss of subsequent testicular function.
- Significant risk of infertility as defined by: cyclophosphamide equivalent dose (CED) ≥4000 mg/m2; cisplatin 500 mg/m2; carboplatin 2000 mg/m2; BMT; TBI; testicular radiation >2.5 Gy; or medical condition or malignancy that requires removal of all or part of one or both testicles.
- Are newly diagnosed or recurrent disease if patient has NOT received therapy viewed as likely to result in complete and permanent loss of testicular function.
- Have not been diagnosed with a medical condition significantly increasing their risk of complications from anesthesia and surgery.
What Will Happen During This Study?
The study will will have 3 categories that will determine treatment.
- Category 1 patients will have all or part of one or both testicles removed as part of treatment of a disease.
- Includes advanced stage/grade testicular cancers; testicular metastases; treatment of hormonally sensitive cancers (i.e. prostate) that necessitate bilateral orchiectomy
- Category 2 patients will have all or part of one or both testicles removed for the prevention of a disease.
- Includes carriers of genes that predispose to hereditary cancers of the testicles or prostate; increased risk or personal history of hormonally sensitate cancers
- Category 3 patients will have all or part of one testicle removed only for fertility preservation who have a medical or surgical condition where the clinically indicated treatment is likely to cause infertility.
- Includes high- and intermediate-risk chemo or radiation treatments for a variety of neoplastic and malignany disorders; conditioning for BMT for malignant diseases and non-malignant disorders
Principal Investigator
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