This is a Phase III, single center, open label randomized comparative trial to evaluate intravaginal culture using INVOcell vs. traditional IVF to generate day 5 embryos Pilot: 40 couples (80 patients), randomized to receive either intravaginal culture (n=20) using the INVOcell or traditional IVF (n=20) Primary Endpoints: Blastocyst generation rate: number of day 5 embryos of good quality defined as 2BB or greater (expansion of embryo 2,3,4,5 or 6 and inner cell mass and outer cell mass grades of A or B) or higher using the Gardner Grading System divided by the number of eggs incubated Patient acceptability of INVOcell and intravaginal culture.~Secondary Endpoints: Live birth rate: number of cycles with a live birth divided by the number of cycles with embryo transfers.~Clinical pregnancy rate: number of cycles with fetal heartbeat at week 7 divided by the number of cycles with embryo transfers.~Fertilization rate: Number of embryos obtained after incubation divided by the number of oocytes placed in the device.~Embryo transfer rate: Number of cycles initiated divided by the number of cycles with embryo transfers Miscarriage rate: Number of miscarriages divided by the number of cycles with embryo transfers Multiple rate: Number cycles with twins or triplets divided by the number of cycles with embryo transfers Miscarriage rate per clinical pregnancy: Number of miscarriages divided by the number of cycles with clinical pregnancy
The purpose of this study is to evaluate intravaginal culture using the medical device INVOcell to generate day 5 blastocysts in comparison to traditional IVF.