Actively Recruiting
Autologous Testicular Tissue Transplantation for Fertility Restoration
Led by Universitair Ziekenhuis Brussel · Updated on 2026-04-23
5
Participants Needed
1
Research Sites
13 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
Researchers are investigating autologous testicular tissue transplantation as a method to restore fertility in men who had their testicular tissue frozen as prepubertal boys due to cancer or hematological diseases. This approach is considered when no sperm suitable for intra-cytoplasmic sperm injection (ICSI) is found in the ejaculate despite cryopreservation efforts. The goal is to restore spermatogenesis and fertility by transplanting the preserved tissue back into the patient. The study involves transplanting autologous testicular tissue that was previously frozen during childhood. Men who return for transplantation will first undergo semen and blood analyses. If no usable sperm are found, the transplantation procedure will be performed. Graft removal and histological studies will occur 12 months after grafting. Participants will be followed up with imaging, hormonal, biomarker, and complication assessments at 3, 6, 9, 12, and 15 months post-grafting. Participants will be monitored closely for up to 15 months after transplantation to assess restoration of sperm production and overall fertility. Evaluations include semen analysis for sperm presence in the graft, imaging, hormonal studies, and biomarker assessments at specified intervals. Safety and potential complications will also be tracked. The study aims to provide important information on the feasibility and outcomes of this novel fertility restoration method.
CONDITIONS
Brief Title
Autologous Testicular Tissue Transplantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male patients who opted as prepubertal boys to enroll in the fertility preservation program
- Age between 18 and 50 years old
- Female partner younger than 43 years old
- No spermatozoa suitable for intra-cytoplasmic sperm injection (ICSI) found on at least two semen analyses
- Normal standardized preliminary and preoperative blood sampling results
- Complete remission of the oncological or hematological disease
- Approval from treating oncologist or relevant specialist for testicular tissue preservation
- Negligible risk of malignant cells in testicular tissue based on multidisciplinary assessment
- Presence of spermatogonial stem cells confirmed in thawed tissue fragments
- Written informed consent for transplantation and follow-up, including consent for children born after procedure
You will not qualify if you...
- Risk of malignant cells present in the testicular tissue
- Contraindication for surgery
- Contraindication for pregnancy in the female partner
- Body mass index (BMI) over 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Graft removal is planned 12 months after transplantation
Participants receive autologous testicular tissue transplantation to restore spermatogenesis and fertility.
1 transplantation visit and graft removal visit at 12 months
Duration - Up to 15 months post-grafting
Participants are followed up to monitor graft function, hormonal levels, imaging, biomarkers, and complications after transplantation.
Visits at 3, 6, 9, 12, and 15 months post-transplantation
Trial Site Locations
Total: 1 location
1
UZ Brussel Centre for Reproductive Medicine
Brussels, Belgium, 1090
Actively Recruiting
Research Team
V
Veerle Vloeberghs, MD
H
Herman Tournaye, MD PhD
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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