Ultrasound-Guided Rete Testis Approach to Sperm Aspiration and Spermatogonial Stem Cell Transplantation in Patients with Azoospermia.
Amanda Colvin Zielen, Karen A Peters, Gunapala Shetty...
https://pubmed.ncbi.nlm.nih.gov/40365444Actively Recruiting
Led by University of Pittsburgh · Updated on 2026-04-22
10
Participants Needed
1
Research Sites
22 weeks
Total Duration
This research aims to evaluate the safety and feasibility of spermatogonial stem cell transplantation and testicular tissue grafting to restore fertility in male participants who have previously frozen testicular tissue before undergoing treatments that risk infertility. The study focuses on adult men affected by infertility due to loss or damage of spermatogonial stem cells caused by diseases or medical therapies such as chemotherapy or radiation. It addresses a critical need for patients who could not preserve semen samples prior to treatment, especially prepubertal males. Participants will receive one of two experimental procedures: autologous transplantation of testicular cells, including spermatogonial stem cells, using ultrasound-guided rete testis injection, or autologous grafting of intact testicular tissue pieces under the skin of the scrotum. Both methods use the participant's own previously cryopreserved testicular tissue or cells. These procedures are designed to stimulate sperm production and are monitored for safety and effectiveness. During the study, participants will be assessed for the return of sperm production between 3 months and 1 year after treatment. Researchers will also monitor for any surgical complications within 3 months and track cancer recurrence over a 5-year period. Participant involvement includes medical evaluations, clearance from hematologists or oncologists, and follow-up visits to measure outcomes related to fertility restoration and safety. The total duration and follow-up extend up to 5 years, ensuring thorough monitoring of long-term effects.
CONDITIONS
Spermatogonial Stem Cell (SSC) Transplant and Testicular Tissue Grafting
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You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 1 year
Participants undergo spermatogonial stem cell transplant and testicular tissue grafting to restore sperm production.
1 baseline visit and multiple follow-up visits over 1 year
Total: 1 location
1
Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
J
Jennifer L Anglin
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Amanda Colvin Zielen, Karen A Peters, Gunapala Shetty...
https://pubmed.ncbi.nlm.nih.gov/40365444