Fertility Restoration With Autografting of Cryopreserved Immature Testicular Tissue

Cliniques universitaires Saint-Luc- Université Catholique de Louvain20 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Azoospermia or Severe Oligozoospermia Infertility Autologous Transplantation

Interventions

autologous transplantation of cryopreserved testicular tissuePROCEDURE

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.

Eligibility

Sex: MALEMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

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

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.

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

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.