Actively Recruiting

Phase Not Applicable
Age: 18Years - 50Years
MALE
NCT05414045

Autologous Testicular Tissue Transplantation

Led by Universitair Ziekenhuis Brussel · Updated on 2026-04-23

5

Participants Needed

1

Research Sites

309 weeks

Total Duration

On this page

Sponsors

U

Universitair Ziekenhuis Brussel

Lead Sponsor

V

Vrije Universiteit Brussel

Collaborating Sponsor

AI-Summary

What this Trial Is About

Freezing testicular tissue of prepubertal boys is a method for preserving spermatogonial stem cells in case of imminent gonadotoxic treatment during childhood. In case of total azoospermia or absence of spermatozoa that can be used for intra-cytoplasmic injection (ICSI) in adulthood, the investigators intend to perform the first in men autologous testicular tissue transplantation to restore fertility.

CONDITIONS

Official Title

Autologous Testicular Tissue Transplantation

Who Can Participate

Age: 18Years - 50Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants must have opted as a prepubertal boy to enroll in a fertility preservation program and had testicular tissue cryopreserved after cancer or hematological diagnosis with parental consent
  • At least 18 years old
  • If female partner exists, she must be younger than 43 years
  • No sperm suitable for intra-cytoplasmic sperm injection (ICSI) on two semen analyses
  • Normal results from standardized preliminary and preoperative blood tests
  • Complete remission of cancer or hematologic disease
  • Approval from treating oncologist or specialist if non-oncological disease was reason for tissue preservation
  • Negligible risk of malignant cells in testicular tissue based on multidisciplinary assessment
  • Presence of spermatogonial stem cells confirmed in at least one thawed tissue fragment
  • Written informed consent for transplantation, follow-up, and future children born after the procedure
Not Eligible

You will not qualify if you...

  • Risk of malignant cells present in testicular tissue
  • Contraindication for surgery
  • Contraindication for pregnancy in female partner
  • Body mass index (BMI) above 32
  • Heavy smoking (10 or more cigarettes per day)
  • Unstable psychological condition

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

UZ Brussel Centre for Reproductive Medicine

Brussels, Belgium, 1090

Actively Recruiting

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Research Team

V

Veerle Vloeberghs, MD

CONTACT

H

Herman Tournaye, MD PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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