The study is a prospective, multi- center, multiple-arm, feasibility study to evaluate the safety and efficacy of the Previvo System in the recovery of embryos.~This study will recruit up to 500 healthy premenopausal volunteers. Subjects will undergo either natural cycle (NC)/intrauterine insemination (IUI), or controlled ovarian hyperstimulation (COH)/intrauterine insemination (IUI) and have the lavage procedure performed 4-6 days post IUI. It is anticipated that embryos recovered will be cryopreserved for future use or donated for future use.~Subjects will be followed up with for up to 30 days after the lavage procedure. All data will be collected on paper CRFs and analyzed by the Principal Investigator and Study Sponsor.
This is a feasibility study intended to demonstrate the Previvo Uterine Lavage System's ability to recover embryos from the uterus following either natural cycle (NC)/intrauterine insemination (IUI), or controlled ovarian hyperstimulation (COH)/intrauterine insemination (IUI).