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Search / Trial NCT05414045

Autologous Testicular Tissue Transplantation

Launched by UNIVERSITAIR ZIEKENHUIS BRUSSEL · Jun 7, 2022

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a method called autologous testicular tissue transplantation. It aims to help men who were treated for cancer or certain blood disorders as boys and want to become fathers later in life. The process involves freezing testicular tissue from prepubertal boys to save special cells that can develop into sperm. If these men find themselves unable to produce sperm as adults, the trial will explore whether transplanting their own preserved testicular tissue can restore their fertility.

To be eligible for this trial, participants must be at least 18 years old and have a desire to become a parent. They should have a stable relationship with a female partner who is under 43 years old. Additionally, the participant must have been diagnosed with azoospermia, which means no sperm is found in their semen, and they must be in complete remission from their previous health issues. Those who join the trial can expect to undergo a procedure to transplant their frozen testicular tissue, and they will be monitored afterward, especially if they have children born from this procedure. It's important to note that certain health conditions or risks, such as the possibility of cancer cells in the testicular tissue, may prevent someone from participating in the trial.

Gender

MALE

Eligibility criteria

  • The eligible patients opted as a prepubertal boy to enroll in the fertility preservation program and on the moment of cancer diagnosis or hematological disorder, their parents have agreed to cryopreserve testicular tissue for later autologous transplantation.
  • Inclusion Criteria:
  • At least 18 years old
  • Desire to become a parent at the moment of intake
  • Stable relationship with a female partner and minimal one year cohabiting
  • Age of female partner \< 43 year
  • Azoospermia on 2 semen analyses
  • Normal standardised preliminary and preoperative bloodsampling results
  • Complete remission of the oncological or hematological disease
  • Approval of the treating oncologist or other specialist in case of non-oncological disease as reason for the testicular tissue preservation as a child
  • Risk for presence of malignant cells in testicular tissue is negligible (according to multidisciplinary assessment)
  • Presence of SSCs (positive MAGE staining) in one or two of the thawed fragments (If absence of SSCs in two of the thawed fragments, the case will be discussed multidisciplinary)
  • Written informed consent for the transplantation of cryopreserved testicular tissue and follow-up after the procedure and of children born eventually after this procedure
  • Exclusion criteria:
  • Risk for presence of malignant cells in the testicular tissue
  • Contra-indication for surgery
  • Contra-indication for pregnancy in the female partner
  • BMI \> 32
  • Heavy smoking (≥10 cigarettes/day)
  • Instable psychological condition

About Universitair Ziekenhuis Brussel

Universitair Ziekenhuis Brussel (UZ Brussel) is a leading academic medical center in Belgium, renowned for its commitment to advancing healthcare through innovative research and clinical trials. As a prominent institution affiliated with the Vrije Universiteit Brussel, UZ Brussel integrates cutting-edge medical research with high-quality patient care. The hospital's multidisciplinary teams are dedicated to exploring novel therapeutic approaches and contributing to the development of evidence-based treatments, ensuring the highest standards of safety and efficacy in clinical research. With a strong focus on collaboration and knowledge dissemination, UZ Brussel plays a pivotal role in shaping the future of medicine and improving patient outcomes.

Locations

Brussels, , Belgium

Patients applied

0 patients applied

Trial Officials

Veerle Vloeberghs, MD

Principal Investigator

CRG UZ Brussel

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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