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NCT05189405 Clinical Trial

3 Year Retrospective Analysis of IVF in Comparison With INVOcell

Infertility Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05189405
Other study ID # CP-019
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date October 12, 2021
Est. completion date February 28, 2022

Study information
Verified date December 2021
Source INVO Bioscience, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 450
Est. completion date February 28, 2022
Est. primary completion date February 28, 2022
Accepts healthy volunteers
Gender Female
Age group 18 Years to 42 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• INVOcell IVC
Embryo development in intravaginal incubation

Locations
Country Name City State
United States CARE Fertility Bedford Texas
United States Piedmont Reproductive Endocrinology Group Greenville South Carolina
United States Carolina Conceptions Raleigh North Carolina
United States THE NEW HOPE CENTER for Reproductive Medicine Virginia Beach Virginia

Sponsors (1)
Lead Sponsor Collaborator
INVO Bioscience, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Embryo development Characteristics of embryo quality and phase of development and transfer rates 5 days
Primary Clinical pregnancy rate Clinical pregnancy rate 5 days
Primary Live birth rate Live birth rate 5 days
Secondary Maternal Adverse Events Adverse events noted by the women that received IVF and INVOcell IVC 5 days
Secondary Offspring adverse events Adverse events noted for the offspring 5 days
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