3 Year Retrospective Analysis of IVF in Comparison With INVOcell

December 29, 2021 updated by: INVO Bioscience, Inc.

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

450

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Raleigh, North Carolina, United States, 27607
        • Carolina Conceptions
    • South Carolina
      • Greenville, South Carolina, United States, 29615
        • Piedmont Reproductive Endocrinology Group
    • Texas
      • Bedford, Texas, United States, 76022
        • CARE Fertility
    • Virginia
      • Virginia Beach, Virginia, United States, 23452
        • The New Hope Center for Reproductive Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 42 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
INVOcell IVC
IVF using intravaginal incubation with INVOcell device for embryo development.
Device: INVOcell IVC
Embryo development in intravaginal incubation
Traditional IVF (tIVF)
Traditional IVF using laboratory equipment and incubators for embryo development

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Embryo development
Time Frame: 5 days
Characteristics of embryo quality and phase of development and transfer rates
5 days
Clinical pregnancy rate
Time Frame: 5 days
Clinical pregnancy rate
5 days
Live birth rate
Time Frame: 5 days
Live birth rate
5 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maternal Adverse Events
Time Frame: 5 days
Adverse events noted by the women that received IVF and INVOcell IVC
5 days
Offspring adverse events
Time Frame: 5 days
Adverse events noted for the offspring
5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

INVO Bioscience, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 12, 2021

Primary Completion (Anticipated)

February 28, 2022

Study Completion (Anticipated)

February 28, 2022

Study Registration Dates

First Submitted

December 29, 2021

First Submitted That Met QC Criteria

December 29, 2021

First Posted (Actual)

January 12, 2022

Study Record Updates

Last Update Posted (Actual)

January 12, 2022

Last Update Submitted That Met QC Criteria

December 29, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP-019

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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