- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05479474
Platelet Rich Plasma Testis Treatment for Infertile Men
March 25, 2024 updated by: Michael Eisenberg, Stanford University
Platelet Rich Plasma Testis
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.
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Satvir Basran
- Phone Number: 650-723-0948
- Email: sbasran@stanford.edu
Study Locations
-
-
California
-
Stanford, California, United States, 94304
- Recruiting
- Stanford Urology Clinic
-
Contact:
- Satvir Basran
- Phone Number: 650-723-0948
- Email: sbasran@stanford.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Platelet rich plasma treatment arm
After consent in obtained, the patient 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
sperm present
Time Frame: 3 months after PRP injection
|
A TESE procedure will be performed to determine if sperm are present
|
3 months after PRP injection
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 18, 2023
Primary Completion (Estimated)
January 1, 2025
Study Completion (Estimated)
January 1, 2025
Study Registration Dates
First Submitted
July 21, 2022
First Submitted That Met QC Criteria
July 26, 2022
First Posted (Actual)
July 29, 2022
Study Record Updates
Last Update Posted (Actual)
March 26, 2024
Last Update Submitted That Met QC Criteria
March 25, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 65917
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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