Home › Male Infertility › NCT04298255
Experimental Round Spermatid Injection (ROSI) to Treat Infertile Couples
Who can join
Ages 18 and older · Men
Full eligibility criteria
Inclusion Criteria: * 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 Criteria: * Males with obstructive azoospermia * Males with presence an adequate number of elongated spermatids or spermatozoa
About the study
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.
What is being tested
- Round Spermatid Injection (ROSI) (other)
- Half ROSI-half Sperm Donor Fertilization (other)
Sponsor: Wake Forest University Health Sciences · Participants: 50 · Started: Aug 24, 2020
Contact the study team
- Karla M Oliver · Phone: 336-713-3123
Official record on ClinicalTrials.gov — NCT04298255
Locations in the U.S.
| North Carolina | Carolinas Fertility Institute (CFI), Winston-Salem |
Conditions
From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.