Fertility Restoration With Autografting of Cryopreserved Immature Testicular Tissue
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: autologous transplantation of cryopreserved testicular tissue.
- Who it may be relevant to
- Registry conditions: Azoospermia or Severe Oligozoospermia, Infertility, Autologous Transplantation. Basic parameters: 18 years — 40 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Interventions
- 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.
Primary outcome measures
- 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).]
Secondary outcome measures (1)
- Assesment of conception potential of sperm recovered in grafts and used in ART [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.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Belgium · 1 center
- Cliniques universitaires Saint-Luc, Université catholique de Louvain — Brussels
Identifiers
NCT: NCT07542626 · TESTIGRAFT