Status:
RECRUITING
Experimental Round Spermatid Injection (ROSI) to Treat Infertile Couples
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
Carolinas Fertility Institute (CFI)
Wake Forest Institute for Regenerative Medicine (WFIRM)
Conditions:
Infertility, Male
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
The purpose of this research study is to evaluate if special types of cells called round spermatids can be gathered from men with non-obstructive azoospermia and used (in absence of elongated spermati...
Detailed Description
Azoospermia is defined as the absence of sperm in the ejaculate. Around 1% of general population suffers from azoospermia. Men who were rendered infertile due to a non-obstructive azoospermia, who hav...
Eligibility Criteria
Inclusion
- Males with no elongated spermatids or spermatozoa present but with round spermatids present on TESE (Testicular Sperm Extraction)
- Male diagnosed with non-obstructive Azoospermia
- Male partner ≥18
- Female partner greater than 18 years of age and less than 38 years of age or Anti Mullerian Hormone (AMH) greater than 2 ng/ml.
Exclusion
- Males with obstructive azoospermia
- Males with presence an adequate number of elongated spermatids or spermatozoa
Key Trial Info
Start Date :
August 24 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04298255
Start Date
August 24 2020
End Date
July 1 2026
Last Update
September 16 2025
Active Locations (1)
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1
Carolinas Fertility Institute (CFI)
Winston-Salem, North Carolina, United States, 27103