Experimental Round Spermatid Injection (ROSI) to Treat Infertile Couples
Wake Forest University Health Sciences
50 participants
Aug 24, 2020
INTERVENTIONAL
Conditions
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 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.
Eligibility
Inclusion Criteria4
- 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 Criteria2
- Males with obstructive azoospermia
- Males with presence an adequate number of elongated spermatids or spermatozoa
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Interventions
In Vitro Fertilization using Round Spermatid Injection (ROSI)
Half ROSI-half Sperm Donor Fertilization
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04298255