NCT05479474

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
8mo left

Started Jan 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
Jan 2023Dec 2026

First Submitted

Initial submission to the registry

July 21, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 29, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

January 18, 2023

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

January 13, 2026

Status Verified

January 1, 2026

Enrollment Period

4 years

First QC Date

July 21, 2022

Last Update Submit

January 12, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • sperm present

    A TESE procedure will be performed to determine if sperm are present

    3 months after PRP injection

Study Arms (1)

Platelet rich plasma treatment arm

EXPERIMENTAL

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.

Biological: Platelet rich plasma

Interventions

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.

Platelet rich plasma treatment arm

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men over the age of 18 diagnosed with NOA and at least one failed TESE, negative mapping or negative biopsy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford Urology Clinic

Stanford, California, 94304, United States

RECRUITING

MeSH Terms

Conditions

Infertility, MaleAzoospermia, NonobstructiveAzoospermia

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesInfertilityMale Urogenital Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 21, 2022

First Posted

July 29, 2022

Study Start

January 18, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

January 13, 2026

Record last verified: 2026-01

Locations