3 Year Retrospective Analysis of IVF in Comparison With INVOcell

INVO Bioscience

Status: Unknown

Conditions: Infertility

Treatments: Device: INVOcell IVC

Study type: Observational

Funder types: Industry

Identifiers

NCT05189405

CP-019

Details and patient eligibility

About

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.

Full 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

Enrollment: 450 estimated patients

Sex: Female

Ages: 18 to 42 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects that have received infertility treatment with either INVOcell IVC or standard IVF during the same timeframe. All subjects treated with the standard of care IVF method during the same timeframe that the center used INVOcell IVC were included in the retrospective data collection.

Exclusion criteria

• Not applicable

Trial design

450 participants in 2 patient groups

INVOcell IVC

Description:

IVF using intravaginal incubation with INVOcell device for embryo development.

Treatment:

Device: INVOcell IVC

Traditional IVF (tIVF)

Description:

Traditional IVF using laboratory equipment and incubators for embryo development