Experimental Round Spermatid Injection (ROSI) to Treat Infertile Couples

What this Trial Is About

This research investigates whether round spermatids, a type of immature sperm cell, can be collected from men with non-obstructive azoospermia and used to create pregnancy through a procedure called Round Spermatid Injection (ROSI). Men with this condition often lack mature sperm cells but may still produce round spermatids. The study also evaluates the safety and effects of ROSI on embryos and aims to address the limitations of traditional ROSI methods. Participants will undergo one of two procedures: either injecting extracted round spermatids from the male partner into eggs from the female partner, or fertilizing half of the female partner's eggs with round spermatids and the other half with donor sperm. This new ROSI method involves careful selection and activation of round spermatids to improve fertilization outcomes. The study monitors embryos from fertilization through development stages. Throughout the study, researchers will assess fertility rates the day after ROSI, blastocyst formation and aneuploidy rates 3 to 5 days after injection, chemical pregnancy rates starting 4 weeks post-fertilization, and live birth rates at full term. Participants will be closely monitored during these stages to track embryo development and pregnancy outcomes, with the study concluding after birth data is collected.

Experimental Round Spermatid Injection (ROSI) to Treat Infertile Couples