Actively Recruiting
Experimental Round Spermatid Injection (ROSI) to Treat Infertile Couples
Led by Wake Forest University Health Sciences · Updated on 2025-09-16
50
Participants Needed
1
Research Sites
305 weeks
Total Duration
On this page
Sponsors
W
Wake Forest University Health Sciences
Lead Sponsor
C
Carolinas Fertility Institute (CFI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 spermatids and spermatozoa) to reliably and effectively create pregnancy with a procedure called Round Spermatid Injection (ROSI). This process is similar to In Vitro Fertilization, or 'IVF'. In addition, this study wants to test the safety of ROSI and see what effects (good and bad) it has on embryo created from this method.
CONDITIONS
Official Title
Experimental Round Spermatid Injection (ROSI) to Treat Infertile Couples
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males with no elongated spermatids or spermatozoa present but with round spermatids present on Testicular Sperm Extraction (TESE)
- Male diagnosed with non-obstructive azoospermia
- Male partner aged 18 years or older
- Female partner aged over 18 years and under 38 years or with Anti Mullerian Hormone (AMH) greater than 2 ng/ml
You will not qualify if you...
- Males with obstructive azoospermia
- Males with an adequate number of elongated spermatids or spermatozoa present
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Carolinas Fertility Institute (CFI)
Winston-Salem, North Carolina, United States, 27103
Actively Recruiting
Research Team
K
Karla M Oliver
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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