Restoring fertility by autografting frozen immature testicular tissue
Official title: 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
Run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain · NCT07542626 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 40 Years |
| Sex | Men only |
| Enrollment | 20 (estimated) |
| Sponsor | Cliniques universitaires Saint-Luc- Université Catholique de Louvain Academic / other |
| Locations | 1 site (Brussels) |
| Status | Recruiting |
| Started | November 19, 2025 |
| Main results expected | November 2035 |
| Study ends | November 2037 |
| Registry record updated | April 21, 2026 |
| Trial ID | NCT07542626 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.