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Clinical Trials in Belgium / NCT07542626
Recruiting Not applicable

Fertility Restoration With Autografting of Cryopreserved Immature Testicular Tissue

NCT07542626 · tracked via the Priya Life Science Belgium tracker
Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Phase
Not applicable
Started
2025-11-19
Last updated
2026-04-21

Condition(s) studied

Azoospermia or Severe OligozoospermiaInfertilityAutologous Transplantation

Investigational drug(s) / intervention(s)

autologous transplantation of cryopreserved testicular tissue

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.

Study summary

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.

Eligibility

Sex
MALE
Min age
18 Years
Max age
40 Years
Healthy volunteers
No
Inclusion Criteria: all are required * patients who have completed their gonadotoxic treatment * patients who are in good health after care of the primary disease based on hemato-oncologist input * patients with proven azoospermia in adulthood and child's wish requesting transplantation * patients who cryopreserved and stored their immature testicular tissue (in conformity with regulatory requirements) * in case of prior hematological malignant disease or metatstatic cancer, if the multidisciplinary assesment considers the risk of cancer cell contamination is negligible Exclusion Criteria: * patients for whom the cryostored tissue presents a non-negligible risk of cancer cells contamination * patients presenting with a contraindication for general anethesia

Primary outcome measure(s)

  • Assessment of graft function — 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).
    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.

Trial sites (1)

FacilityCityRegionStatus
Cliniques universitaires Saint-Luc, Université catholique de Louvain Brussels Belgium Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07542626 on ClinicalTrials.gov ↗ ← All trials in Belgium