NCT05189405

3 Year Retrospective Analysis of IVF in Comparison With INVOcell

A 3 Year Retrospective Analysis of Fertility Clinic's of In Vitro Fertilization (IVF) in Comparison With INVOcell Intravaginal Culture (INVOcell IVC) Device

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 450 (estimated)
• Sponsor: INVO Bioscience, Inc. · Industry
• Sex: Female
• Age: 18 Years – 42 Years
• Healthy volunteers: —

Summary

Retrospective chart review of data on the use of traditional IVF and INVOcell IVC collected from clinics using both technologies. The retrospective data will be utilized for a comparison of the two methods.

Detailed description

The following aspects of data will be collected to support the analysis of the two methods * Procedure details for including oil overlay and incubation time frame * Characteristics of embryo quality and phase of development and transfer rates * Clinical pregnancy rate * Live birth rate Secondary: Data regarding safety * Adverse events noted by the women that received IVF and INVOcell IVC * Adverse events noted for the offspring

Conditions

• Infertility

Interventions

Type	Name	Description
DEVICE	INVOcell IVC	Embryo development in intravaginal incubation

Timeline

• Start date: 2021-10-12
• Primary completion: 2022-02-28
• Completion: 2022-02-28
• First posted: 2022-01-12
• Last updated: 2022-01-12

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study