Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
5 participants
INTERVENTIONAL
2024-11-22
2030-10-29
Brief Summary
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Detailed Description
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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, in case no spermatozoa are found 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Patients
Autologous testicular tissue transplantation of prepubertal frozen testicular tissue
Freezing testicular tissue of prepubertal boys is a method for preserving spermatogonial stem cells (SSCs).
If the patient has a childwish on adult age and in case no spermatozoa are found in the ejaculate, the investigators will perform autologous testicular tissue transplantation with the primary objective being to restore spermatogenesis and fertility.
Interventions
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Autologous testicular tissue transplantation of prepubertal frozen testicular tissue
Freezing testicular tissue of prepubertal boys is a method for preserving spermatogonial stem cells (SSCs).
If the patient has a childwish on adult age and in case no spermatozoa are found in the ejaculate, the investigators will perform autologous testicular tissue transplantation with the primary objective being to restore spermatogenesis and fertility.
Eligibility Criteria
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Inclusion Criteria
* Desire to become a parent at the moment of intake
* Stable relationship with a female partner and minimal one year cohabiting
* Age of female partner \< 43 year
* Azoospermia 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 SSCs (positive MAGE staining) in one or two of the thawed fragments (If absence of SSCs 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
* Contra-indication for surgery
* Contra-indication for pregnancy in the female partner
* BMI \> 32
* Heavy smoking (≥10 cigarettes/day)
* Instable psychological condition
18 Years
50 Years
MALE
No
Sponsors
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Vrije Universiteit Brussel
OTHER
Universitair Ziekenhuis Brussel
OTHER
Responsible Party
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Principal Investigators
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Veerle Vloeberghs, MD
Role: PRINCIPAL_INVESTIGATOR
CRG UZ Brussel
Locations
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UZ Brussel Centre for Reproductive Medicine
Brussels, , Belgium
Countries
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Central Contacts
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Other Identifiers
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2019-477
Identifier Type: -
Identifier Source: org_study_id
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