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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

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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04644380
Study type Interventional
Source INVO Bioscience, Inc.
Contact
Status Completed
Phase N/A
Start date December 2, 2020
Completion date December 11, 2020
View Details
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