Fertility IssuesTTCNCT06387498
Testicular Tissue Cryopreservation (TTC)
A study testing Testicular tissue biopsy and cryopreservation in people with Fertility Issues, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The "Testicular Tissue Cryopreservation" study is open to a subset of patients facing disease or treatment regimens that could lead to infertility (gonadotoxic therapies). For some of these patients, experimental testicular tissue cryopreservation is the only fertility preservation option available. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Fertility Issues
- What is being tested?
- Testicular tissue biopsy and cryopreservation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Sep 2020to 30 Dec 2027
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male at any age.
- Scheduled to undergo surgery, chemotherapy, drug treatment and/or radiation for the treatment or prevention of a medical condition or malignancy with risk of causing permanent and complete loss of subsequent testicular function. Be in significant risk of infertility as defined by:
- Cyclophosphamide equivalent dose (CED) ≥4 g/m2
- Total body irradiation (TBI)
- Testicular radiation >2.5 Gy
- Cisplatin 500 mg/m2
Show all 13Show fewer
- Bone Marrow Transplant (BMT)
- Or have a medical condition or malignancy that requires removal of all or part of one or both testicles.
- Or have newly diagnosed or recurrent disease. Those who were not enrolled at the time of initial diagnosis (i.e., patients with recurrent disease) are eligible if they have not previously received therapy that is viewed as likely to result in complete and permanent loss of testicular function.
- Have two testicles if undergoing elective removal of a testicle for fertility preservation only. Note: removal of both testicles will limit fertility preservation options.
- Sign an approved informed consent and authorization permitting the release of personal health information. The patient and/or the patient's legally authorized guardian must acknowledge in writing that consent for specimen collection has been obtained, in accordance with institutional policies approved by the U.S. Department of Health and Human Services.
- Consent for serum tests for infectious diseases [including Hepatitis B Surface Antigen, Hepatitis C Virus (HCV) Antibody, and Human Immunodeficiency Virus (HIV) antigen/antibody screen to be performed at the time of testicular tissue harvesting.
- Undergo a full history and physical examination and obtain standard pre-operative clearance (based on the most recent American College of Cardiology/American Heart Association (ACC/AHA) Guideline for Perioperative Cardiovascular Evaluation for Noncardiac Surgery) as determined by their primary surgeon.
Who cannot join
- Patients will be ineligible for participation in this study if they are:
- Diagnosed with psychological, psychiatric, or other conditions which prevent giving fully informed consent.
- Diagnosed with an underlying medical condition that significantly increases their risk of complications from anesthesia and surgery.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Colorado
Aurora, Colorado, 80045
Jocelyn Phipers, RN, 303-724-7807, jocelyn.phipers@cuanschutz.edu
Kristine Corkum, MD, Kristine.Corkum@childrenscolorado.org
About this study
Official title: Testicular Tissue Cryopreservation for Fertility Preservation in Patients Facing Infertility-causing Diseases or Treatment Regimens.
The "Testicular Tissue Cryopreservation" study is open to a subset of patients facing disease or treatment regimens that could lead to infertility (gonadotoxic therapies). For some of these patients, experimental testicular tissue cryopreservation is the only fertility preservation option available. The overall objective of this study is to determine the feasibility and acceptability of testicular tissue cryopreservation in male patients of all ages who have a condition or will undergo a treatment that can cause infertility.
Read the detailed description
For male patients who currently have no options for fertility preservation, this research proposal will enable optimization of testicular tissue procurement and processing, cryopreservation, and diagnosis/elimination of malignant cell contamination to ensure safety for future fertility-restoring treatments. While results from animal models and human organ donor experiments support the efficacy of testicular tissue/cell cryopreservation for fertility preservation and subsequent restoration, rigorous safety and efficacy data in human patients who will undergo infertility-causing therapies is lacking. However, the patients being recruited for this study currently have no options for future therapies aimed at fertility preservation without the preservation of their testicular tissue/cells prior to treatment. Thus, the current study will provide a potential resource for future fertility restoration.
- Conditions
- Fertility Issues
- Being tested
- Testicular tissue biopsy and cryopreservation
- Keywords
- Fertility preservation
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testicular tissue biopsy and cryopreservationProcedure or surgery
Surgical Procurement of Testicular Tissue: At early stages of technology development, simple orchiectomy (removal of one entire testicle) may give the best chance of preserving sufficient cells for effective therapy. However, incisional biopsy of up to 25% of tissue from one testis (wedge resection) will also be presented to the patient as an alternative option. The amount of testicular parenchyma removed will be at the discretion of the surgeon.
| Study group | Role | What they receive |
|---|---|---|
| Testicular Tissue Cryopreservation | Experimental | Enrolled participants will undergo a testicular tissue biopsy. The method and amount of tissue procurement will be at the discretion of the surgeon. Receives: Procedure: Testicular tissue biopsy and cryopreservation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility, as Assessed via the Percentage of Eligible Patients who do a Procedure
Determine feasibility of testicular tissue cryopreservation (TTC) in male patients receiving gonadotoxic therapies who desire fertility preservation. Calculated by the percentage of eligible patients that elect to proceed with TTC.
Measured: Up 3 months after prescribed gonadotoxic therapy
Feasibility, as Assessed via Percentage of Patients who Attempted a Procedure who were able to Cryopreserve
Determine feasibility of testicular tissue cryopreservation (TTC) in male patients receiving gonadotoxic therapies who desire fertility preservation. Calculated by the number of study participants whose tissue was successfully cryopreserved.
Measured: Up to 48 hours after testicular tissue biopsy
Safety, as Assessed via the Number of Participants with At Least One Pre-specified Adverse Event
The investigators will determine the safety of testicular tissue cryopreservation (TTC) in male patients receiving gonadotoxic therapies who desire fertility preservation. The number of participants with at least one of the following adverse events: 1) Bleeding, 2) Post-op infection, or 3) Long-term pain.
Measured: Every six months throughout the life of the study (up to 7 years)
Safety, as Assessed via the Number of Participants with At Least One Pre-specified Adverse Event
The investigators will determine the safety of testicular tissue cryopreservation (TTC) in male patients receiving gonadotoxic therapies who desire fertility preservation. The number of participants with bleeding.
Measured: 24 hours of the procedure
Safety, as Assessed via the Number of Participants with At Least One Pre-specified
The investigators will determine the safety of testicular tissue cryopreservation (TTC) in male patients receiving gonadotoxic therapies who desire fertility preservation. The number of participants with post-op infection.
Measured: within 72 hours of the procedure
Safety, as Assessed via the Number of Participants with At Least One Pre-specified
The investigators will determine the safety of testicular tissue cryopreservation (TTC) in male patients receiving gonadotoxic therapies who desire fertility preservation. The number of participants with long-term pain.
Measured: Assessed at 6 months
Secondary outcomes (1)
Acceptability, as Assessed via Annual Survey Regret Score
The Decision Regret Scale measures distress or remorse after a health care decision. Possible scores range from 0-100, with higher scores indicating high regret.
Measured: Annually until the age of majority for the male participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start28 Sep 2020
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fertility IssuesStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kristine Corkum, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06387498
- Sponsor's protocol ID
- 20-2286
- Acronym
- TTC
- Status last verified
- Sep 2025
- First submitted
- 13 May 2022
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testicular Tissue Cryopreservation for Fertility Preservation in Patients Facing Infertility-causing Diseases or Treatment Regimens.
- ClinicalTrials.gov ID
- NCT06387498
- Acronym / sponsor ID
- TTC / 20-2286
- Conditions
- Fertility Issues
- Keywords
- Fertility preservation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 28 Sep 2020 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 29 Apr 2024 (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.
The "Testicular Tissue Cryopreservation" study is open to a subset of patients facing disease or treatment regimens that could lead to infertility (gonadotoxic therapies). For some of these patients, experimental testicular tissue cryopreservation is the only fertility preservation option available. The overall objective of this study is to determine the feasibility and acceptability of testicular tissue cryopreservation in male patients of all ages who have a condition or will undergo a treatment that can cause infertility.
Detailed description
For male patients who currently have no options for fertility preservation, this research proposal will enable optimization of testicular tissue procurement and processing, cryopreservation, and diagnosis/elimination of malignant cell contamination to ensure safety for future fertility-restoring treatments. While results from animal models and human organ donor experiments support the efficacy of testicular tissue/cell cryopreservation for fertility preservation and subsequent restoration, rigorous safety and efficacy data in human patients who will undergo infertility-causing therapies is lacking. However, the patients being recruited for this study currently have no options for future therapies aimed at fertility preservation without the preservation of their testicular tissue/cells prior to treatment. Thus, the current study will provide a potential resource for future fertility restoration.
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 and cryopreservationEnrolled participants will undergo a testicular tissue biopsy. The method and amount of tissue procurement will be at the discretion of the surgeon. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- Male at any age.
- Scheduled to undergo surgery, chemotherapy, drug treatment and/or radiation for the treatment or prevention of a medical condition or malignancy with risk of causing permanent and complete loss of subsequent testicular function. Be in significant risk of infertility as defined by:
- Or have a medical condition or malignancy that requires removal of all or part of one or both testicles.
- Or have newly diagnosed or recurrent disease. Those who were not enrolled at the time of initial diagnosis (i.e., patients with recurrent disease) are eligible if they have not previously received therapy that is viewed as likely to result in complete and permanent loss of testicular function.
- Have two testicles if undergoing elective removal of a testicle for fertility preservation only. Note: removal of both testicles will limit fertility preservation options.
Key exclusion criteria (3 listed)
- Diagnosed with psychological, psychiatric, or other conditions which prevent giving fully informed consent.
- Diagnosed with an underlying medical condition that significantly increases their risk of complications from anesthesia and surgery.
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 biopsy and cryopreservationSurgical Procurement of Testicular Tissue: At early stages of technology development, simple orchiectomy (removal of one entire testicle) may give the best chance of preserving sufficient cells for effective therapy. However, incisional biopsy of up to 25% of tissue from one testis (wedge resection) will also be presented to the patient as an alternative option. The amount of testicular parenchyma removed will be at the discretion of the surgeon. | Procedure or surgery | Testicular Tissue Cryopreservation |
Primary outcome
Feasibility, as Assessed via the Percentage of Eligible Patients who do a Procedure
Time frame: Up 3 months after prescribed gonadotoxic therapy
Determine feasibility of testicular tissue cryopreservation (TTC) in male patients receiving gonadotoxic therapies who desire fertility preservation. Calculated by the percentage of eligible patients that elect to proceed with TTC.
Feasibility, as Assessed via Percentage of Patients who Attempted a Procedure who were able to Cryopreserve
Time frame: Up to 48 hours after testicular tissue biopsy
Determine feasibility of testicular tissue cryopreservation (TTC) in male patients receiving gonadotoxic therapies who desire fertility preservation. Calculated by the number of study participants whose tissue was successfully cryopreserved.
Safety, as Assessed via the Number of Participants with At Least One Pre-specified Adverse Event
Time frame: Every six months throughout the life of the study (up to 7 years)
The investigators will determine the safety of testicular tissue cryopreservation (TTC) in male patients receiving gonadotoxic therapies who desire fertility preservation. The number of participants with at least one of the following adverse events: 1) Bleeding, 2) Post-op infection, or 3) Long-term pain.
Safety, as Assessed via the Number of Participants with At Least One Pre-specified Adverse Event
Time frame: 24 hours of the procedure
The investigators will determine the safety of testicular tissue cryopreservation (TTC) in male patients receiving gonadotoxic therapies who desire fertility preservation. The number of participants with bleeding.
Safety, as Assessed via the Number of Participants with At Least One Pre-specified
Time frame: within 72 hours of the procedure
The investigators will determine the safety of testicular tissue cryopreservation (TTC) in male patients receiving gonadotoxic therapies who desire fertility preservation. The number of participants with post-op infection.
Safety, as Assessed via the Number of Participants with At Least One Pre-specified
Time frame: Assessed at 6 months
The investigators will determine the safety of testicular tissue cryopreservation (TTC) in male patients receiving gonadotoxic therapies who desire fertility preservation. The number of participants with long-term pain.
1 secondary outcome
Acceptability, as Assessed via Annual Survey Regret Score
Time frame: Annually until the age of majority for the male participant
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 16 Sep 2025.
- Individual participant dataSharing planned: No
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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.
Kristine Corkum, MD principal investigator
University of Colorado, Denver
1 site 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 and cryopreservation in people with Fertility Issues, run by University of Colorado, Denver at 1 site in United States.
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 13 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 16 Sep 2025. 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 United States. 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 Kristine Corkum, MD ((720) 777-6174, Kristine.Corkum@childrenscolorado.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility, as Assessed via the Percentage of Eligible Patients who do a Procedure (time frame: Up 3 months after prescribed gonadotoxic therapy). The study lists 6 primary outcomes in all. 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 16 Sep 2025.