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New treatment option for Cancer
Official title Autologous Testicular Tissue Transplantation
ClinicalTrials.gov ID: NCT05414045
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 50, men only
You may be able to join if
- The eligible patients opted as a prepubertal boy to enroll in the fertility preservation program and on the moment of cancer diagnosis or...
- 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
You likely can't join 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
See the full eligibility criteria
- 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...
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Brussels, Belgium
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years to 50 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brussels, Belgium. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.