Restoring fertility by autografting frozen immature testicular tissue
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
NA · Cliniques universitaires Saint-Luc- Université Catholique de Louvain · NCT07542626
This pilot trial will try transplanting a man's own immature testicular tissue, frozen during childhood, back into adult men with azoospermia who want to have children.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Male |
| Sponsor | Cliniques universitaires Saint-Luc- Université Catholique de Louvain (other) |
| Locations | 1 site (Brussels) |
| Trial ID | NCT07542626 on ClinicalTrials.gov |
What this trial studies
The procedure returns cryopreserved immature testicular tissue collected before gonadotoxic treatment in childhood into adult patients with proven azoospermia and a desire for biological children. Surgical sperm retrieval is attempted first and, if unsuccessful, autologous transplantation of the thawed tissue is performed during the same operation. Candidates are selected after completion of cancer therapy, medical clearance, and multidisciplinary review to ensure negligible risk of cancer-cell contamination. The single-center program includes post-operative follow-up to monitor safety and signs of renewed spermatogenesis.
Who should consider this trial
Good fit: Adult men who cryopreserved immature testicular tissue before gonadotoxic therapy, have completed treatment, have confirmed azoospermia, desire children, and have minimal risk of tissue contamination.
Not a fit: Patients whose stored tissue carries a significant risk of cancer cell contamination, who cannot undergo general anesthesia, or whose transplanted tissue fails to restart sperm production are unlikely to benefit.
Why it matters
Potential benefit: If successful, the procedure could restore sperm production and offer a path to biological fatherhood for men who froze testicular tissue as boys.
How similar studies have performed: While cryopreservation of immature testicular tissue has been practiced for years and animal studies show restored spermatogenesis, autologous testicular tissue transplantation in humans remains largely experimental with limited outcome data.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Brussels
- Cliniques universitaires Saint-Luc, Université catholique de Louvain — Brussels, Belgium (RECRUITING)
Study contacts
- Principal investigator: Christine Wyns, MD, PhD — Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Study coordinator: Christine Wyns, MD, PhD, Full Professor
- Email: christine.wyns@saintluc.uclouvain.be
- Phone: 003227641101
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Azoospermia or Severe Oligozoospermia, Infertility, Autologous Transplantation, autotransplantation of immature testicular tissue, fertility preservation, prepubertal boys, cryopreserved testicular tissue, prepubertal testicular tissue