Last updated on May 2018

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


Brief description of study

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

Detailed Study Description

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

Clinical Study Identifier: NCT02802176

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