Autologous Testicular Tissue Transplantation

NCT05414045 | Recruiting

• 1 other identifier: 2019-477
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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

Cancer; Sickle Cell Thalassemia; Hematologic Diseases

Outcome Measures

Primary Outcomes (1)

• Restoration of spermatogenesis and fertility by performing an autologous testicular tissue transplantation. Primary endpoint is the presence of spermatozoa in the graft.

  Freezing testicular tissue of prepubertal boys is a method for preserving spermatogonial stem cells. If the patient has no spermatozoa suitable for ICSI in the ejaculate in adulthood, the investigators will perform autologous testicular tissue transplantation with the primary objective being to restore spermatogenesis and fertility. Grafting will be performed intra-testicular and intrascrotal for each patient. Grafts will be removed 12 months after grafting. Primary endpoint is the presence of spermatozoa in the grafted tissue. In the IVF laboratory mechanical mincing and enzymatic digestion will be performed on the tissue to find spermatozoa. If spermatozoa are present concentration and motility will be available.

  Graft-removal of intratesticular and intrascrotal grafts is planned 12 months after grafting.

Secondary Outcomes (5)

• Histological study to define the optimal transplantation site

  Graft-removal of intratesticular grafts and intrascrotal grafts are planned 12 months after initial grafting. Histological study will be performed 12 months after initial grafting

• Imaging study

  Each patient in the study will be followed-up after screening during a period of 12 months post-grafting on 3, 6, 9 and 12 months after initial grafting.

• Endocrinological (hormonal) study

  Each patient in the study will be followed-up after screening during a period of 12 months post-grafting on 3, 6, 9 and 12 months after initial grafting.

• Biomarker Study

  Each patient in the study will be followed-up after screening during a period of 12 months post-grafting on 3, 6, 9 and 12 months after initial grafting.

• Complications

  Each patient in the study will be follow-up after screening during a period of 15 months post-grafting.

Study Arms (1)

Patients

EXPERIMENTAL

Procedure: Autologous testicular tissue transplantation of prepubertal frozen testicular tissue

Interventions

Autologous testicular tissue transplantation of prepubertal frozen testicular tissue PROCEDURE

Freezing testicular tissue of prepubertal boys is a method for preserving spermatogonial stem cells. If no spermatozoa suitable for ICSI are detected in the ejaculate, the investigators will perform autologous testicular tissue transplantation with the primary objective being to restore spermatogenesis and fertility.

Patients

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Male infertile survivors of childhood cancer or a hematological disease who underwent prepubertal testicular tissue cryopreservation in case of gonadotoxic treatment.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• At least 18 years old
• In case of female partner, age \< 43 year
• Absence of spermatozoa that can be used for ICSI 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 spermatogonial stem cells (positive MAGE staining) in one or two of the thawed fragments (If absence of spermatogonial stem cells 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead
• Vrije Universiteit Brussel: collaborator

Study Sites (1)

UZ Brussel Centre for Reproductive Medicine

Brussels, 1090, Belgium

RECRUITING

MeSH Terms

Conditions

Neoplasms; Hematologic Diseases

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases

Study Officials

• Veerle Vloeberghs, MD

  CRG UZ Brussel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Veerle Vloeberghs, MD

CONTACT

003224776699; veerle.vloeberghs@uzbrussel.be

Herman Tournaye, MD PhD

CONTACT

003224776699; herman.tournaye@uzbrussel.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All eligible patients for the study will have the same treatment: autologous testicular tissue transplantation with testicular tissue containing spermatogonial stem cells frozen at pre-pubertal age. Transplantation will be performed subcutaneously in the scrotum and intra-testicular.

Study Record Dates

• First Submitted: February 17, 2022
• First Posted: June 10, 2022
• Study Start: November 22, 2024
• Primary Completion (Estimated): July 29, 2030
• Study Completion (Estimated): October 29, 2030
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)