Azoospermia or Severe OligozoospermiaTESTIGRAFTNCT07542626
Fertility Restoration With Autografting of Cryopreserved Immature Testicular Tissue
A study testing autologous transplantation of cryopreserved testicular tissue in people with Azoospermia or Severe Oligozoospermia and Infertility, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men only
- Conditions the study is for
- Azoospermia or Severe Oligozoospermia, Infertility, Autologous Transplantation
- What is being tested?
- autologous transplantation of cryopreserved testicular tissue
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- 19 Nov 2025to Nov 2037
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- patients for whom the cryostored tissue presents a non-negligible risk of cancer cells contamination
- patients presenting with a contraindication for general anethesia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Cliniques universitaires Saint-Luc, Université catholique de Louvain
Brussels, 1200
Patricia Van Aken, Study nurse, 003227647803, patricia.vanaken@saintluc.uclouvain.be
christine.wyns@saintluc.uclouvain.be
About this study
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
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.
- Being tested
- autologous transplantation of cryopreserved testicular tissue
- Keywords
- autotransplantation of immature testicular tissue, fertility preservation, prepubertal boys, cryopreserved testicular tissue, prepubertal testicular tissue
- Medical subject headings
- Azoospermia, Oligospermia, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous transplantation of cryopreserved testicular tissueProcedure or surgery
Also called testicular tissue autografting
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: autologous transplantation of cryopreserved testicular tissue |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start19 Nov 2025
- Primary completionNov 2035 (estimated)
- Study completionNov 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Azoospermia or Severe OligozoospermiaStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christine Wyns, MD, PhD, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07542626
- Sponsor's protocol ID
- TESTIGRAFT
- Acronym
- TESTIGRAFT
- Status last verified
- Apr 2026
- First submitted
- 20 Mar 2026
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07542626
- Acronym / sponsor ID
- TESTIGRAFT / TESTIGRAFT
- Keywords
- autotransplantation of immature testicular tissue, fertility preservation, prepubertal boys, cryopreserved testicular tissue, prepubertal testicular tissue
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 19 Nov 2025 (actual)
- Primary completion
- Nov 2035 (estimated)
- Study completion
- Nov 2037 (estimated)
- First posted
- 21 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autologous transplantation of cryopreserved immature testicular tissue in azoospermic adults | Experimental | Procedure: autologous transplantation of cryopreserved testicular tissueAvascular transplantation of own testicular tissue pieces cryopreserved during childhood will be performed during a surgical sperm retrieval procedure when no sperm is found. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- patients for whom the cryostored tissue presents a non-negligible risk of cancer cells contamination
- patients presenting with a contraindication for general anethesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| autologous transplantation of cryopreserved testicular tissueAlso: testicular tissue autograftingAvascular 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. | Procedure or surgery | Autologous transplantation of cryopreserved immature testicular tissue in azoospermic adults |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christine Wyns, MD, PhD principal investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing autologous transplantation of cryopreserved testicular tissue in people with Azoospermia or Severe Oligozoospermia and Infertility, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christine Wyns, MD, PhD, Full Professor (003227641101, christine.wyns@saintluc.uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.