Assessment of the INVOcell Culture Device When Used for up to Five-Day Incubation

Infertility Clinical Trial

Official title: Assessment of the INVOcell Culture Device When Used for up to Five-Day Incubation

Status Completed

Clinical Trial Summary

The INVOcell Culture Device received de novo request for 3-day intravaginal incubation. The device is held in place with the intravaginal cavity by a Retention Device. The clinical study will assess the ability of a modified Retention Device to hold INVOcell in place during 5-day vaginal incubation as well as comfort and vaginal irritation as secondary endpoints.

Clinical Trial Description

This is a single center, open label non-comparative prospective trial to evaluate the retention of the INVOcell IVC with the Retention Device over the vaginal incubation period of up to 5 days.

The purpose of this study is to assess the retention of the INVOcell IVC device with the Retention Device over the vaginal incubation period of up to 5 days.

Primary Endpoint

• Retention of the INVOcell IVC device with the Retention Device over the vaginal incubation period of up to 5 days.

Secondary Endpoint

• Comfort of the INVOcell IVC and Retention Device

• Vaginal tissue reactions during the vaginal incubation

• Optical clarity and the ability to visualize the embryos after the incubation ;

Related Conditions & MeSH terms

• Infertility

• NCT number: NCT04644380
• Study type: Interventional
• Source: INVO Bioscience, Inc.
• Status: Completed
• Phase: N/A
• Start date: December 2, 2020
• Completion date: December 11, 2020