Autologous Transplantation, Azoospermia or Severe Oligozoospermia, Infertility
Conditions
Keywords
autotransplantation of immature testicular tissue, fertility preservation, prepubertal boys, cryopreserved testicular tissue, prepubertal testicular tissue
Brief summary
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
PROCEDUREautologous 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.
Sponsors
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of graft function | 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). | 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
| Measure | Time frame | Description |
|---|---|---|
| Assesment of conception potential of sperm recovered in grafts and used in ART | 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. | 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. |
Countries
Belgium
Contacts
CONTACTChristine Wyns, MD, PhD, Full Professor
PRINCIPAL_INVESTIGATORChristine Wyns, MD, PhD
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Outcome results
None listed