About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
patients for whom the cryostored tissue presents a non-negligible risk of cancer cells contamination
patients presenting with a contraindication for general anethesia
Trial design
Single group
Treatments tested in this trial
autologous transplantation of cryopreserved testicular tissue
Procedure/SurgeryAvascular 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.