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This is a pilot clinical trial to evaluate the feasibility and outcome of autologous transplantation of immature testicular tissue cryopreserved during childhood as a method of fertility preservation for prepubertal boys in case of gonadotoxic therapies.
Freezing of immature testicular tissue is performed since the early 2000s and a number of our patients have now reached reproductive age. In case of childwish and azoospermia in adulthood, surgical sperm retrieval is planned and if unsucessful transplantation of the patient's own cryopreserved tissue will be performed during the same surgical intervention as a fertility restoration method.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autologous transplantation of cryopreserved immature testicular tissue in azoospermic adults | Experimental | Avascular transplantation of own testicular tissue pieces cryopreserved during childhood will be performed during a surgical sperm retrieval procedure when no sperm is found. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| autologous transplantation of cryopreserved testicular tissue | Procedure | Avascular autologous transplantation of frozen-thawed immature testicular tissue pieces will be performed in azoospermic adult patients during a surgical sperm retrieval procedure if no sperm is found peroperatively. |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of graft function | Blood sampling for hormones and growth of the graft as visulalized by ultrasound will be performed during follow-up. Presence of sperm will be evaluated at the recovery of the graft. | Assessments of hormones and growth of the graft will be performed at 1 month (M), 3 M, 6M, 12M, 24 M after grafting/transplantation procedure. Presence of sperm will be performed at graft recovery (immediately during surgery on fresh and fixed samples). |
| Measure | Description | Time Frame |
|---|---|---|
| Assesment of conception potential of sperm recovered in grafts and used in ART | Sperm recovered from grafts and cryopreserved will be used to achieve a conception. Upon the patient's child wish, thawing of cryopreserved sperm will be performed and used for intracytoplasmic sperm injection (ICSI) to obtain embryos. Achievement of a pregnancy after embryo replacement will be assessed by measuring HCGb in female partner blood and if positive its evolution will be assessed by ultrasound. Standard pregancy follow-up will be performed once an intrauterine pregnancy is confirmed at ultrasound. |
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Inclusion Criteria: all are required
Exclusion Criteria:
Male adult survivors of a childhood cancer who cryopreserved their tissue for own use as a fertility preservation method are eligible.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christine Wyns, MD, PhD, Full Professor | Contact | 003227641101 | christine.wyns@saintluc.uclouvain.be |
| Name | Affiliation | Role |
|---|---|---|
| Christine Wyns, MD, PhD | Cliniques universitaires Saint-Luc- Université Catholique de Louvain | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cliniques universitaires Saint-Luc, Université catholique de Louvain | Recruiting | Brussels | 1200 | Belgium |
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|
|
| HCGb in blood at Day 15 (+-1 Day) post-ICSI and if positive confirmed after 48 Hours (+-24 Hours). Ultrasound 15 Days +-7 Days after ICSI. |
| ID | Term |
|---|---|
| D053713 | Azoospermia |
| D009845 | Oligospermia |
| D007246 | Infertility |
| ID | Term |
|---|---|
| D007248 | Infertility, Male |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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