NCT07542626

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
140mo left

Started Nov 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress4%
Nov 2025Nov 2037

Study Start

First participant enrolled

November 19, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 21, 2026

Completed
9.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2035

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2037

Last Updated

April 21, 2026

Status Verified

April 1, 2026

Enrollment Period

10 years

First QC Date

March 20, 2026

Last Update Submit

April 17, 2026

Conditions

Azoospermia or Severe OligozoospermiaInfertilityAutologous Transplantation

Keywords

autotransplantation of immature testicular tissuefertility preservationprepubertal boyscryopreserved testicular tissueprepubertal testicular tissue

Outcome Measures

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.

    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

    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.

Study Arms (1)

Autologous transplantation of cryopreserved immature testicular tissue in azoospermic adults

EXPERIMENTAL

Avascular transplantation of own testicular tissue pieces cryopreserved during childhood will be performed during a surgical sperm retrieval procedure when no sperm is found.

Procedure: autologous transplantation of cryopreserved testicular tissue

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.

Also known as: testicular tissue autografting
Autologous transplantation of cryopreserved immature testicular tissue in azoospermic adults

Eligibility Criteria

Age18 Years - 40 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMale adult survivors of a childhood cancer who cryopreserved their tissue for own use as a fertility preservation method are eligible.
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • patients for whom the cryostored tissue presents a non-negligible risk of cancer cells contamination
  • patients presenting with a contraindication for general anethesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cliniques universitaires Saint-Luc, Université catholique de Louvain

Brussels, 1200, Belgium

RECRUITING

MeSH Terms

Conditions

AzoospermiaOligospermiaInfertility

Condition Hierarchy (Ancestors)

Infertility, MaleGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Christine Wyns, MD, PhD

    Cliniques universitaires Saint-Luc- Université Catholique de Louvain

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christine Wyns, MD, PhD, Full Professor

CONTACT

003227641101christine.wyns@saintluc.uclouvain.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2026

First Posted

April 21, 2026

Study Start

November 19, 2025

Primary Completion (Estimated)

November 1, 2035

Study Completion (Estimated)

November 1, 2037

Last Updated

April 21, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)