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
• Status: Active, not recruiting
• 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
• 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
• 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

Related Conditions & MeSH terms

• Infertility

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