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:

  1. Optimize conditions for shipping, cryopreserving, and thawing testicular tissue
  2. Determine presence of germ cells in the patients' testicular tissue
  3. Learn the impact of diseases or medical treatments on testicular morphology and function
  4. 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.
For a full list of eligibility requirements, visit https://clinicaltrials.gov/study/NCT02972801

 

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

Nicholas D. Yeager
MD

Hematology & Oncology

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