An interventional study of autologous transplantation of cryopreserved testicular tissue in Azoospermia or Severe Oligozoospermia, Infertility and Autologous Transplantation, sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain. Recruiting at 1 site in Belgium. Open to male participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-04-21.
Sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Not applicable, Interventional, and Treatment
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.
59 studies on the registry are indexed under Azoospermia; 17 are open to participants now.
This study's planned enrollment of 20 is below the median of 57 across 32 interventional studies indexed under Azoospermia.
Browse Azoospermia studies →Cliniques universitaires Saint-Luc- Université Catholique de Louvain is the lead sponsor of 350 studies on the registry; 64 are open to participants now.
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Inclusion Criteria: all are required
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Avascular transplantation of own testicular tissue pieces cryopreserved during childhood will be performed during a surgical sperm retrieval procedure when no sperm is found.
Procedure: autologous transplantation of cryopreserved testicular tissue
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.
Also known as: testicular tissue autografting
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.
Time frame: 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).
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.
Time frame: 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.
Plan to share: No
No publications or documents are linked to this record.
Started Nov 2025 (actual). Primary completion is estimated for Nov 2035, 120 months after the start.
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