Testicular Tissue Cryopreservation (TTC)
ConditionFertility Issues
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
AgeNot listed
SponsorUniversity of Colorado, Denver
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male at any age.
Cyclophosphamide equivalent dose (CED) ≥4 g/m2
Total body irradiation (TBI)
Testicular radiation >2.5 Gy
Disqualifiers
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 design
Design model
Single group
Treatments tested in this trial
Testicular tissue biopsy and cryopreservation
Procedure/SurgerySurgical 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.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Testicular Tissue CryopreservationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Up 3 months after prescribed gonadotoxic therapy2
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.
Time frame
Up to 48 hours after testicular tissue biopsy3
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.
Time frame
Every six months throughout the life of the study (up to 7 years)4
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.
Time frame
24 hours of the procedureSecondary 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.
Time frame
Annually until the age of majority for the male participantSponsors and contacts
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Source ClinicalTrials.gov