Transplanting frozen testicular tissue to restore fertility in men

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study focuses on the autologous transplantation of cryopreserved testicular tissue from prepubertal boys who have undergone fertility preservation due to cancer or hematologic diseases. The aim is to restore spermatogenesis and fertility in men who experience total azoospermia in adulthood. The process involves analyzing semen and blood to determine the presence of spermatozoa, and if absent, proceeding with the transplantation of the preserved tissue. This innovative approach builds on previous fertility preservation efforts and aims to provide a viable option for men wishing to conceive after treatment.

Why it matters

Who can join: the full rules

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

Where it's running

• UZ Brussel Centre for Reproductive Medicine
  Brussels, Belgium Recruiting

Study contacts

• Principal investigator: Veerle Vloeberghs, MD — CRG UZ Brussel
• Study coordinator: Veerle Vloeberghs, MD
• Email: veerle.vloeberghs@uzbrussel.be
• Phone: 003224776699

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.