Fertility Restoration With Autografting of Cryopreserved Immature Testicular Tissue

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-40
SponsorCliniques universitaires Saint-Luc- Université Catholique de Louvain

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • autologous transplantation of cryopreserved testicular tissue

    Procedure/Surgery

    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.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Autologous transplantation of cryopreserved immature testicular tissue in azoospermic adultsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

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 outcomes

1

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.

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.

Other outcomes

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