This is a single center, open label non-comparative prospective trial to evaluate the retention of the INVOcell IVC with the Retention Device over the vaginal incubation period of up to 5 days.~The purpose of this study is to assess the retention of the INVOcell IVC device with the Retention Device over the vaginal incubation period of up to 5 days.~Primary Endpoint~• Retention of the INVOcell IVC device with the Retention Device over the vaginal incubation period of up to 5 days.~Secondary Endpoint~Comfort of the INVOcell IVC and Retention Device~Vaginal tissue reactions during the vaginal incubation~Optical clarity and the ability to visualize the embryos after the incubation
The INVOcell Culture Device received de novo request for 3-day intravaginal incubation. The device is held in place with the intravaginal cavity by a Retention Device. The clinical study will assess the ability of a modified Retention Device to hold INVOcell in place during 5-day vaginal incubation as well as comfort and vaginal irritation as secondary endpoints.