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NCT Number: NCT07542626

Fertility Restoration With Autografting of Cryopreserved Immature Testicular Tissue

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.

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Key information

Conditions

Azoospermia or Severe Oligozoospermia Autologous Transplantation Azoospermia Genital Diseases Genital Diseases, Male Infertility Infertility, Male Male Urogenital Diseases Oligospermia Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Cliniques universitaires Saint-Luc, Université catholique de Louvain

Brussels, 1200, Belgium

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

autologous transplantation of cryopreserved testicular tissue

Procedure

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.

Other names: testicular tissue autografting

Primary outcomes

  1. Assessment of graft function

    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).

    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 outcomes

  1. Assesment of conception potential of sperm recovered in grafts and used in ART

    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.

    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.

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Interested in participating?

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Sponsors and collaborators

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Other

Registry information

Official study 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

Acronym: TESTIGRAFT

Important dates

Study start
2025
Primary completion
2035
Study completion
2037
First posted
Apr 21, 2026
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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