Fertility Issues Clinical Trial
— TTCOfficial 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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | December 30, 2027 |
Est. primary completion date | December 30, 2027 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | N/A and older |
Eligibility | Inclusion Criteria: 1. Male at any age. 2. 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 - Bone Marrow Transplant (BMT) 3. Or have a medical condition or malignancy that requires removal of all or part of one or both testicles. 4. 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. 5. Have two testicles if undergoing elective removal of a testicle for fertility preservation only. Note: removal of both testicles will limit fertility preservation options. 6. 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. 7. 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. 8. 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. Exclusion Criteria Patients will be ineligible for participation in this study if they are: 1. Diagnosed with psychological, psychiatric, or other conditions which prevent giving fully informed consent. 2. Diagnosed with an underlying medical condition that significantly increases their risk of complications from anesthesia and surgery. |
Country | Name | City | State |
---|---|---|---|
United States | University of Colorado | Aurora | Colorado |
Lead Sponsor | Collaborator |
---|---|
University of Colorado, Denver |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Up 3 months after prescribed gonadotoxic therapy | |
Primary | 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. | Up to 48 hours after testicular tissue biopsy | |
Primary | 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. | Every six months throughout the life of the study (up to 7 years) | |
Primary | 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. | 24 hours of the procedure | |
Primary | 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. | within 72 hours of the procedure | |
Primary | 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. | Assessed at 6 months | |
Secondary | 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. | Annually until the age of majority for the male participant |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04519593 -
ABSOLUTELY: A Temporary Uterine Blood Supply Occlusion for Laparoscopic Myomectomy in Patients With UTErine LeiomYoma
|
N/A | |
Recruiting |
NCT05980091 -
Optimal Timing of Euploid Day 6 Blastocyst Transfer in Frozen HRT Cycles, Day 6 or Day 7 of Progesterone Administration.
|
Phase 1 | |
Recruiting |
NCT06043609 -
Outcome Evaluation After Fertility Preservation
|
||
Not yet recruiting |
NCT05048771 -
Fertility and Temporality in Pediatric Oncology
|
||
Completed |
NCT05368194 -
Food Intake and Epigenetic Alteration in the Spermatozoa of Singletons and Twins
|
N/A | |
Recruiting |
NCT05176535 -
Determination of Vaginal Colonization and the Effect of an Oral Probiotic (PROSALVAG)
|
N/A | |
Recruiting |
NCT06360471 -
Fertility Preservation and Pregnancy and Offspring Health Outcomes in Female Cancer
|
||
Recruiting |
NCT05271981 -
Fertility After Uterine Artery Embolization
|
||
Recruiting |
NCT05815719 -
Continuous Double Ovarian Stimulation.
|
Phase 4 | |
Recruiting |
NCT06127875 -
Effects of Trying to Conceive Using an Home- or Hospital-based Ovulation Monitoring on Stress
|
||
Recruiting |
NCT05658848 -
Effect of Collaborative Infertility Counseling on Coping Strategies and Marital Satisfaction
|
N/A | |
Not yet recruiting |
NCT05385848 -
Autologous Platelet-rich Plasma (PRP) Infusion to Improve Outcomes in Women With Ovarian Insufficiency: a Pilot Study
|
N/A | |
Completed |
NCT04396210 -
Patients Perspectives on Discontinuation of Their Fertility Treatment Due to the COVID-19 Pandemic
|
||
Completed |
NCT05134090 -
Percutaneous Laparoscopy for Ovarian Tissue Cryopreservation.
|
||
Completed |
NCT05905289 -
Survival and Reproductive Outcomes of Malignant Ovarian Germ Cell Tumors
|
||
Recruiting |
NCT05316467 -
Weight Management Plus Megestrol Acetate in Early-stage Endometrioid Carcinoma
|
Phase 2/Phase 3 | |
Completed |
NCT04600869 -
Effects of Naturalistic Decision-Making Model-based Oncofertility Care Education
|
N/A | |
Withdrawn |
NCT04683237 -
Liraglutide Plus Megestrol Acetate in Endometrial Atypical Hyperplasia
|
Phase 2/Phase 3 | |
Not yet recruiting |
NCT06179420 -
The Effectiveness of Advanced Decision Support Tool (OPT-IVF) for IVF Treatment
|
||
Recruiting |
NCT06163079 -
Assisted Reproductive Techniques (ART) With Sperm Donation : an Inclusive Model of ART for All Women
|