Experimental Round Spermatid Injection (ROSI) to Treat Infertile Couples
Wake Forest University Health Sciences
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.
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 have been subjected to Testicular Sperm Extraction (TESE) surgery and found to be lacking elongated spermatids or spermatozoa, are commonly advised to consider utilizing a sperm donor or apply for adoption. It is reported that \~30% of men with non-obstructive azoospermia lack elongated spermatids and spermatozoa but may still produce round spermatids (less mature form of haploid germ cells) in their…
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
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
Interventions
- OtherRound Spermatid Injection (ROSI)
In Vitro Fertilization using Round Spermatid Injection (ROSI)
- OtherHalf ROSI-half Sperm Donor Fertilization
Half ROSI-half Sperm Donor Fertilization
Location
- Carolinas Fertility Institute (CFI)Winston-Salem, North Carolina