Experimental Round Spermatid Injection (ROSI) to Treat Infertile Couples

Launched by WAKE FOREST UNIVERSITY HEALTH SCIENCES · Mar 5, 2020

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment option for couples struggling with infertility, specifically focusing on men who have a condition called non-obstructive azoospermia, which means they do not have sperm in their semen due to testicular issues. The study is testing a method called Round Spermatid Injection (ROSI), which involves using special cells from the testicles called round spermatids to help create embryos. This procedure is similar to In Vitro Fertilization (IVF) and aims to see if it can successfully lead to pregnancies, while also monitoring the safety and effects of this method on the embryos created.

To be eligible for this trial, men must have been diagnosed with non-obstructive azoospermia and have round spermatids available from a testicular procedure called TESE (Testicular Sperm Extraction). Additionally, both partners must be at least 18 years old, and the female partner should be under 38 years old or have a specific hormone level that indicates good ovarian function. Participants can expect to undergo the ROSI procedure and will be monitored for any effects, both positive and negative, related to the embryos created through this method. If you’re interested in learning more or think you might qualify, it’s a great idea to talk to your healthcare provider.

Gender

MALE

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