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

This is a Phase IV, single center randomized controlled trial evaluating intra-vaginal
culture using INVOcell versus traditional 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 the Gardner grading system.

- 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

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

- 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