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NCT Number: NCT05414045

Autologous Testicular Tissue Transplantation

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.

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Key information

Conditions

Cancer Hematologic Diseases Hemic and Lymphatic Diseases Neoplasms Sickle Cell Thalassemia

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

UZ Brussel Centre for Reproductive Medicine

Brussels, 1090, Belgium

Location status: Recruiting

About this study

Freezing testicular tissue of prepubertal boys is a method for preserving spermatogonial stem cells. In 2002, the University hospital in Brussels (UZB) was the first hospital worldwide to offer testicular tissue cryobanking for fertility preservation in boys and ado-lescents. Since then, several other centers in Europe and USA have implemented similar fertility preservation programs. However, up till now, autologous transplantations of cryopreserved testicular tissue have not been performed yet.

As soon as a patient returns to the Centre for Reproductive Medicine at UZB with the request to transplant the preserved testicular tissue, the investigators will first analyse semen and blood. If spermatozoa are found in their semen, men can immediately enroll in standard care for natural conception, intra-uterine insemination (IUI), in-vitro fertilization (IVF) or intra-cytoplasmic injection (ICSI). However, if no spermatozoa suitable for ICSI are detected in the ejaculate, the investigators intend to propose and eventually perform autologous testicular tissue transplantation with the primary objective being to restore spermatogenesis and fertility.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • 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

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

Treatment and study plan

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.

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.

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

    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.

Secondary outcomes

  1. Histological study to define the optimal transplantation site

    Time frame: 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

    The presence of sperm-generating stem cells, as well as their possible maturation to sperm cells will be evaluated through available and validated microscopic staining techniques applied to the testicular tissue. The maturity of other, non-sperm-generating testicular cells (Sertoli cells and Leydig cells) will also be evaluated. The results from tissue fragments transplanted to the testicle will be compared to the results from the tissue fragments transplanted to the scrotum. During the removal procedure of the transplanted fragments, a control biopsy (TESE) will be performed on the contra-lateral testicle (the one on which no transplantation was performed).

  2. Imaging study

    Time frame: 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.

    The investigators will study the possibility of analyzing the growth of the transplanted fragments and the development of sperm cell production in these fragments by using ultrasound and Doppler techniques in a non-invasive way. Ultrasound will be performed 3, 6, 9 and 12 months after grafting. These findings will be compared to the findings of the semen and blood analysis and the clinical examination.

  3. Endocrinological (hormonal) study

    Time frame: 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.

    The investigators plan a follow-up of the functionality of the transplanted tissue by performing blood analyses with LH (IU/L), FSH (IU/L), testosterone (ng/L), Inhibine B (ng/L) and Insulin-like factor 3 (INSL3, ng/ml).

    Blood analyses will be repeated 3, 6, 9 and 12 months after the transplantation procedure.

  4. Biomarker Study

    Time frame: 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.

    As an exploratory part of this study, the investigators will study the possibility to predict the presence of testicular spermatogenesis in a non-invasive way (by semen and/or urine samples). If different biomarkers could be identified specificaly for the different stages of spermatogenesis, the development of the transplanted biopsies could be monitored this way. For this study, a urine and semen sample will be needed 3, 6, 9 and 12 months after the transplantation procedure.

  5. Complications

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

    Each patient in the study will be followed-up during a period of 15 months after initial grafting or 3 months after graft-removal to report any complication(s) of the procedures.

Study contacts

Contact information is provided by the study sponsor or research team.

Herman Tournaye, MD PhD

CONTACT

[email protected]

003224776699

Veerle Vloeberghs, MD

CONTACT

[email protected]

003224776699

Sponsors and collaborators

Lead sponsor

Universitair Ziekenhuis Brussel

Other

Collaborators

  • Vrije Universiteit Brussel

Registry information

Official study title

Autologous Testicular Tissue Transplantation for Fertility Restoration

Important dates

Study start
2024
Primary completion
2030
Study completion
2030
First posted
Jun 10, 2022
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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