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

Infertility Clinical Trial

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

Status Terminated

Clinical Trial Summary

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

Clinical Trial Description

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 ;

Related Conditions & MeSH terms

• Infertility

• NCT number: NCT02802176
• Study type: Interventional
• Source: University of California, San Francisco
• Status: Terminated
• Phase: N/A
• Start date: October 2016
• Completion date: August 25, 2022