3 Year Retrospective Analysis of IVF in Comparison With INVOcell

NCT ID: NCT05189405

Last Updated: 2022-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

450 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-12

Study Completion Date

2022-02-28

Brief Summary

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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

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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

Conditions

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Infertility

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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INVOcell IVC

IVF using intravaginal incubation with INVOcell device for embryo development.

INVOcell IVC

Intervention Type DEVICE

Embryo development in intravaginal incubation

Traditional IVF (tIVF)

Traditional IVF using laboratory equipment and incubators for embryo development

No interventions assigned to this group

Interventions

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INVOcell IVC

Embryo development in intravaginal incubation

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

42 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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INVO Bioscience, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Carolina Conceptions

Raleigh, North Carolina, United States

Site Status

Piedmont Reproductive Endocrinology Group

Greenville, South Carolina, United States

Site Status

CARE Fertility

Bedford, Texas, United States

Site Status

THE NEW HOPE CENTER for Reproductive Medicine

Virginia Beach, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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CP-019

Identifier Type: -

Identifier Source: org_study_id

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