RecruitingNot ApplicableNCT07542626

Fertility Restoration With Autografting of Cryopreserved Immature Testicular Tissue

Fertility Restoration With Autotransplantation of Cryopreserved Immature Testicular Tissue (ITT) Restaurer la fertilité à Partir de Tissu Testiculaire Immature (TTI) cryopréservé Par Auto-transplantation du Tissu


Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Enrollment

20 participants

Start Date

Nov 19, 2025

Study Type

INTERVENTIONAL

Conditions

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: MALEMin Age: 18 YearsMax Age: 40 Years

Inclusion Criteria5

  • 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 Criteria2

  • patients for whom the cryostored tissue presents a non-negligible risk of cancer cells contamination
  • patients presenting with a contraindication for general anethesia

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Interventions

PROCEDUREautologous 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.


Locations(1)

Cliniques universitaires Saint-Luc, Université catholique de Louvain

Brussels, Belgium

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NCT07542626


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