Experimental Round Spermatid Injection (ROSI) to Treat Infertile Couples
ConditionInfertility, Male
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorWake Forest University Health Sciences
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
Males with obstructive azoospermia
Males with presence an adequate number of elongated spermatids or spermatozoa
Trial design
Treatments tested in this trial
- Round Spermatid Injection (ROSI)
- Half ROSI-half Sperm Donor Fertilization
Treatment groups
50 Participants
are divided into 2 treatment groupsSponsors and collaborators
Wake Forest University Health Sciences
Lead sponsor
Carolinas Fertility Institute (CFI)
Collaborator
Wake Forest Institute for Regenerative Medicine (WFIRM)
Collaborator
Wake Forest Department of Urology
Collaborator
Source ClinicalTrials.gov