Childhood CancerNCT03180918
Male Fertility Preservation Using Cryopreservation of Testicular Tissue Before Highly Gonadotoxic Cancer Treatment
A study testing testicular tissue biopsy in people with Childhood Cancer and Fertility Disorders, run by Gumy-Pause Fabienne at 3 sites in Switzerland.
Trial summary
Background: Due to the remarkable improvement in treatments these last decades, long term survival can be expected in more than 80% of childhood cancer patients. Unfortunately, cancer treatments can be harmful to the gonads and can affect reproductive and endocrine functions. Read more about this study
- Who is it for?
- Ages 3 months to 18 years, men only
- Conditions the study is for
- Childhood Cancer, Fertility Disorders
- What is being tested?
- testicular tissue biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesSwitzerland
- Study dates
- Jan 2015to Jan 2100
- 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 3 months to 18 years
- Men only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Prepubertal patients aged 3 months and older
- Peri and pubertal patients after failure of sperm cryopreservation
- Patients presenting high risk of infertility because of gonadotoxic treatments (i.e high dose of alkylating agents, testicular irradiation, total body irradiation).
- Multidisciplinary team consensus in favour of proposition to cryopreserve testicular tissue
Who cannot join
- Patients under the age of 3 months
- Refusal of the patient and/or his parents
- Treatments that are not highly gonadotoxic
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Fabienne Gumy-Pause, Dr contact
Switzerland3 sites, 3 recruiting
- Recruiting
UKBB
Basel
Tamara Diesch-Furlanetto, Dr
- Recruiting
Geneva University Hospitals
Geneva, 1211
Fabienne Gumy-Pause, Dr, fabienne.gumypause@hcuge.ch
- Recruiting
CHUV
Lausanne
Maja Beck Popovic, Dr
About this study
Background:
Due to the remarkable improvement in treatments these last decades, long term survival can be expected in more than 80% of childhood cancer patients. Unfortunately, cancer treatments can be harmful to the gonads and can affect reproductive and endocrine functions. While loss of fertility is a major concern for most patients, sperm cryopreservation should be offered to all pubertal male patients. For prepubertal boys, only the experimental option of testicular biopsy in order to cryopreserve testicular stem cells can be proposed.
Read more
Primary aims
- To cryopreserve testicular tissue of prepubertal patient receiving highly gonadotoxic oncological treatment.
Secondary aims
- To cryopreserve testicular tissue after failure of sperm cryopreservation in pubertal patient with high risk of infertility
- To create a database in order to record clinical and biological follow-up data
- To create a research biobank for future research projects
Multicentric study: HUG, CHUV, UKBB
- Conditions
- Childhood Cancer, Fertility Disorders
- Being tested
- testicular tissue biopsy
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
testicular tissue biopsyProcedure or surgery
testicular tissue biopsy during general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| testicular tissue cryopreservation | Experimental | Not described Receives: Procedure: testicular tissue biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of pediatric cancer patient who will undergo testicular tissue cryopreservation for fertility preservation
Measured: 0-20 years
Secondary outcomes (2)
Incidence of complications related to the testicular biopsy (safety)
The safety will be assessed by recording the number of complications of the procedure (e.g. bleeding, infection, testicular atrophy)
Measured: 0-20 years
Comparison of biochemical markers
Comparison of biochemical markers (e.g., FSH; LH, AMH; Inhibin B, SHBG and testosterone) between patients who undergo testicular biopsy and controls
Measured: 0-20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2017
- Study startJan 2015
- Primary completionJan 2100 (estimated)
- Study completionJan 2100 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood CancerStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gumy-Pause Fabienne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gumy-Pause Fabienne, University Hospital, Geneva
- Investigators
- Fabienne Gumy-Pause, Study chair, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03180918
- Sponsor's protocol ID
- PB_2016-01378
- Status last verified
- May 2026
- First submitted
- 31 May 2017
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Male Fertility Preservation Using Cryopreservation of Testicular Tissue Before Highly Gonadotoxic Cancer Treatment
- ClinicalTrials.gov ID
- NCT03180918
- Acronym / sponsor ID
- PB_2016-01378
- Conditions
- Childhood Cancer, Fertility Disorders
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Gumy-Pause FabienneUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Jan 2100 (estimated)
- Study completion
- Jan 2100 (estimated)
- First posted
- 8 Jun 2017 (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.
Background:
Due to the remarkable improvement in treatments these last decades, long term survival can be expected in more than 80% of childhood cancer patients. Unfortunately, cancer treatments can be harmful to the gonads and can affect reproductive and endocrine functions. While loss of fertility is a major concern for most patients, sperm cryopreservation should be offered to all pubertal male patients. For prepubertal boys, only the experimental option of testicular biopsy in order to cryopreserve testicular stem cells can be proposed.
Primary aims
- To cryopreserve testicular tissue of prepubertal patient receiving highly gonadotoxic oncological treatment.
Secondary aims
- To cryopreserve testicular tissue after failure of sperm cryopreservation in pubertal patient with high risk of infertility
- To create a database in order to record clinical and biological follow-up data
- To create a research biobank for future research projects
Multicentric study: HUG, CHUV, UKBB
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| testicular tissue cryopreservation | Experimental | Procedure: testicular tissue biopsy |
Who may qualify
- Ages
- 3 months to 18 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Prepubertal patients aged 3 months and older
- Peri and pubertal patients after failure of sperm cryopreservation
- Patients presenting high risk of infertility because of gonadotoxic treatments (i.e high dose of alkylating agents, testicular irradiation, total body irradiation).
- Multidisciplinary team consensus in favour of proposition to cryopreserve testicular tissue
Key exclusion criteria (3 listed)
- Patients under the age of 3 months
- Refusal of the patient and/or his parents
- Treatments that are not highly gonadotoxic
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 |
|---|---|---|
| testicular tissue biopsytesticular tissue biopsy during general anesthesia | Procedure or surgery | testicular tissue cryopreservation |
Primary outcome
Number of pediatric cancer patient who will undergo testicular tissue cryopreservation for fertility preservation
Time frame: 0-20 years
2 secondary outcomes
Incidence of complications related to the testicular biopsy (safety)
Time frame: 0-20 years
Comparison of biochemical markers
Time frame: 0-20 years
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 27 May 2026.
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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.
Fabienne Gumy-Pause, Dr contact
Fabienne Gumy-Pause study chair
University Hospital, Geneva
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing testicular tissue biopsy in people with Childhood Cancer and Fertility Disorders, run by Gumy-Pause Fabienne at 3 sites in Switzerland.
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 4 inclusion and 3 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 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Switzerland. 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 Fabienne Gumy-Pause, Dr (fabienne.gumypause@hcuge.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of pediatric cancer patient who will undergo testicular tissue cryopreservation for fertility preservation (time frame: 0-20 years). 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 27 May 2026.