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NCT05479474 Clinical Trial

Platelet Rich Plasma Testis Treatment for Infertile Men

Male Infertility Clinical Trial

Official title:
Platelet Rich Plasma Testis

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05479474
Other study ID # 65917
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 18, 2023
Est. completion date January 1, 2025

Study information
Verified date March 2024
Source Stanford University
Contact Satvir Basran
Phone 650-723-0948
Email sbasran@stanford.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Investigate the effect of intratesticular injection of autologous platelet rich plasma (PRP) on sperm retrieval rates and IVF outcomes in infertile men who already underwent a negative sperm retrieval. Currently, there is no alternative treatment after failed TESE. Prior series suggest that intratesticular PRP injections may improve TESE outcomes. We hope to determine whether PRP is an effective treatment for this patient population.

Recruitment information / eligibility
Status Recruiting
Enrollment 10
Est. completion date January 1, 2025
Est. primary completion date January 1, 2025
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria: - Men over the age of 18 diagnosed with NOA and at least one failed TESE, negative mapping or negative biopsy Exclusion Criteria: -

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• Platelet rich plasma
Patients will undergo a blood draw (12 tsp) to prepare the PRP infusion. The use of a centrifuge and an Arteriocyte Magellan kit are necessary for the PRP preparation. After injection of local anesthesia, PRP will be injected into each testicle. On the third month after the testicular PRP procedure, a TESE will be performed If the procedure is successful a new IVF cycle using the sperm procured from the procedure will be done.

Locations
Country Name City State
United States Stanford Urology Clinic Stanford California

Sponsors (1)
Lead Sponsor Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary sperm present A TESE procedure will be performed to determine if sperm are present 3 months after PRP injection
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