Comparing Intra-vaginal Culture of Embryos to In-vitro Culture of Embryos With Minimal Stimulation

Randomized Controlled Trial Comparing Intra-vaginal Culture of Embryos Using INVOcell Device to In-vitro Culture of Embryos Using Minimal Stimulation Protocols

The purpose of this study is to evaluate implantation rate with intra-vaginal culture (IVC) with the INVOcell device versus traditional In-Vitro Fertilization (IVF) while using minimal stimulation protocols

This is a Phase IV, single center randomized controlled trial evaluating intra-vaginal culture (IVC) using INVOcell versus traditional In-Vitro Fertilization (IVF) using oral stimulation or minimal gonadotropin stimulation protocols. The pilot aims to includes 40 women who will be randomized to either the intra-vaginal culture group (N=20) using INVOcell or to the traditional IVF group (N=20). Primary aim is implantation rate, which is defined by number gestational sacs seen on early pregnancy ultrasound divided by number of embryos transferred. Secondary aims are: Embryo quality, which is measured by system similar to the Gardner grading system at cleavage stage. Reported quality will be converted to the simplified SART embryo scoring system which provides an overall categorical embryo grade of "Good", "Fair" or "Poor". Fertilization rate, which is defined by the total number of fertilized oocytes divided by total number of mature oocytes retrieved. This comparison will take place on day-3, as that is when the IVC embryos will be assessed. Clinical pregnancy rate, which is defined by the number of fetal poles with heartbeat seen on ultrasound divided by the number of embryos transferred. Live birth rate, which is defined by the number of living babies delivered divided by the number of transfers

Arm 1: intra-vaginal culture using INVOcell device. Arm 2: Traditional In-Vitro Fertilization (IVF) culture in an embryology laboratory

defined by number gestational sacs seen on early pregnancy ultrasound typically done at 6 weeks of gestational age divided by number of embryos transferred

approximately 4 weeks following randomization. Clinically this is typically done around 6 weeks of gestational age

-Embryo quality, which is measured by system similar to the Gardner grading system at cleavage stage. Reported quality will be converted to the simplified SART embryo scoring system which provides an overall categorical embryo grade of "Good", "Fair" or "Poor".

defined by the total number of fertilized oocytes divided by total number of mature oocytes retrieved

which is defined by the number of fetal poles with heartbeat seen on early pregnancy ultrasound typically done at 6 weeks of gestational age divided by the number of embryos transferred

approximately 4 weeks following randomization. Clinically this is typically done around 6 weeks of gestational age

Inclusion Criteria: Normal uterine cavity One or more years of infertility Normal male partner semen analysis Exclusion Criteria: Age <18 years old or >37 years old Antral Follicle Count (AFC) <8 Abnormal male partner semen analysis or use of donor sperm Vaginal inflammation or genital (vaginal, uterine, tubal) infection Uncontrolled chronic disease (such as uncontrolled diabetes or hypertension) Uterine anatomic abnormalities Allergy to plastics or inability to use diaphragm retention device Untreated hydrosalpinx Current alcohol abuse (defined by >14 drinks/week) Prior history of IVF cycle where fertilization did not occur History of recurrent pregnancy loss