Fertility Restoration With Autografting of Cryopreserved Immature Testicular Tissue

Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Study ID
NCT07542626
Status
Recruiting
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Conditions

  • Autologous Transplantation
  • Azoospermia or Severe Oligozoospermia
  • Infertility

Eligibility Criteria

Sex
MALE
Age
18 Years - 40 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

First listed
Apr 21, 2026
Start date
Nov 19, 2025
Status verified
Apr 2026
Primary completion
Nov 30, 2035
Completion
Nov 30, 2037

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Autologous transplantation of cryopreserved immature testicular tissue in azoospermic adults
    Avascular transplantation of own testicular tissue pieces cryopreserved during childhood will be performed during a surgical sperm retrieval procedure when no sperm is found.

Primary Outcome Measure

Assessment of graft function [ 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). ]

Central Contacts

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