3 Year Retrospective Analysis of IVF in Comparison With INVOcell

• Conditions: Infertility
• Interventions: Device: INVOcell IVC

• Registration Number: NCT05189405
• Lead Sponsor: INVO Bioscience, Inc.

Brief 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

Study Timeline

• Study Start: 2021-10-12
• Status Verified: 2021-12
• Study First Submitted: 2021-12-29
• Study First Submitted QC: 2021-12-29
• Last Update Submitted: 2021-12-29
• Study First Posted: 2022-01-12
• Last Update Posted: 2022-01-12
• Primary Completion: 2022-02-28
• Study Completion: 2022-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 450

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
INVOcell IVC	INVOcell IVC	IVF using intravaginal incubation with INVOcell device for embryo development.

Primary Outcome Measures

Name	Time	Method
Embryo development	5 days	Characteristics of embryo quality and phase of development and transfer rates
Clinical pregnancy rate	5 days	Clinical pregnancy rate
Live birth rate	5 days	Live birth rate

Secondary Outcome Measures

Name	Time	Method
Offspring adverse events	5 days	Adverse events noted for the offspring
Maternal Adverse Events	5 days	Adverse events noted by the women that received IVF and INVOcell IVC

Trial Locations

Locations (4)

Carolina Conceptions; 🇺🇸 Raleigh, North Carolina, United States

CARE Fertility; 🇺🇸 Bedford, Texas, United States

Piedmont Reproductive Endocrinology Group; 🇺🇸 Greenville, South Carolina, United States

THE NEW HOPE CENTER for Reproductive Medicine; 🇺🇸 Virginia Beach, Virginia, United States