NCT04644380

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: INVO Bioscience, Inc. · Industry
• Sex: Female
• Age: 18 Years – 42 Years
• Healthy volunteers: Accepted

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.

Detailed 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

Conditions

• Infertility

Interventions

Type	Name	Description
DEVICE	INVOcell	Female participants undergoing in vitro fertilization (IVF) and or/or Intracytoplasmic Sperm Injection (ICSI) for assisted reproductive will be asked to participate

Timeline

• Start date: 2020-12-02
• Primary completion: 2020-12-11
• Completion: 2020-12-11
• First posted: 2020-11-25
• Last updated: 2021-02-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study