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Assessment of the INVOcell Culture Device When Used for up to Five-Day Incubation

Primary Purpose

Infertility

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
INVOcell
Sponsored by
INVO Bioscience, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility

Eligibility Criteria

18 Years - 42 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Have been informed about the study and have given their written consent.
  • Patients 18 years to 42 years
  • Women who are scheduled for an oocyte retrieval in anticipation of INVOcell IVF.

Exclusion Criteria:

  • Inability to read and speak English fluently
  • Identified vaginal infection
  • Recent pelvic surgery based on clinical history and physical examination.
  • History of toxic shock syndrome
  • Inability to tolerate the placement or wearing of the INVOcell IVC or INVOcell Retention Device.
  • Inability to tolerate a speculum examination
  • Unwilling or unable to wear the INVO Retention (diaphragm) during the incubation.
  • Unable or unwilling to sign informed consent or abide by study follow up assessment requirements.

Sites / Locations

  • American Institute of Reproductive Medicine/IVF Alabama (AIRM)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment Group

Arm Description

During an IVF/IVC cycle, participants will retain the INVOcell Culture Device with the Retention Device in the vaginal cavity for 5 days vaginal incubation

Outcomes

Primary Outcome Measures

Device Retention
The primary endpoint is INVOcell IVC retention with the Retention Device. The following will be assessed: Whether the INVOcell IVC stays in place (is retained within the vaginal cavity) while being used with the Retention Device during 5 days of continuous vaginal incubation.

Secondary Outcome Measures

Comfort
Comfort of the INVOcell IVC while worn with the Retention Device evaluated on a 10-oint Likert scale.
Vaginal tissue reactions
Vaginal tissue reactions during the vaginal incubation based on post removal and assessed by vaginal speculum examination performed to examine the vaginal walls speculum examination post removal vaginal examination.
Optical clarity
Optical clarity and the ability to visualize the embryos after the incubation of the INVOcell device.

Full Information

First Posted
November 20, 2020
Last Updated
February 16, 2021
Sponsor
INVO Bioscience, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04644380
Brief Title
Assessment of the INVOcell Culture Device When Used for up to Five-Day Incubation
Official Title
Assessment of the INVOcell Culture Device When Used for up to Five-Day Incubation
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
December 2, 2020 (Actual)
Primary Completion Date
December 11, 2020 (Actual)
Study Completion Date
December 11, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
INVO Bioscience, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The INVOcell Culture Device received de novo request for 3-day intravaginal incubation. The device is held in place with the intravaginal cavity by a Retention Device. The clinical study will assess the ability of a modified Retention Device to hold INVOcell in place during 5-day vaginal incubation as well as comfort and vaginal irritation as secondary endpoints.
Detailed Description
This is a single center, open label non-comparative prospective trial to evaluate the retention of the INVOcell IVC with the Retention Device over the vaginal incubation period of up to 5 days. The purpose of this study is to assess the retention of the INVOcell IVC device with the Retention Device over the vaginal incubation period of up to 5 days. Primary Endpoint • Retention of the INVOcell IVC device with the Retention Device over the vaginal incubation period of up to 5 days. Secondary Endpoint Comfort of the INVOcell IVC and Retention Device Vaginal tissue reactions during the vaginal incubation Optical clarity and the ability to visualize the embryos after the incubation

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
During an IVF/IVC cycle, participants will retain the INVOcell Culture Device with the Retention Device in the vaginal cavity for 5 days vaginal incubation
Intervention Type
Device
Intervention Name(s)
INVOcell
Other Intervention Name(s)
Intravaginal Culture, IVC, Vaginal incubation
Intervention Description
Female participants undergoing in vitro fertilization (IVF) and or/or Intracytoplasmic Sperm Injection (ICSI) for assisted reproductive will be asked to participate
Primary Outcome Measure Information:
Title
Device Retention
Description
The primary endpoint is INVOcell IVC retention with the Retention Device. The following will be assessed: Whether the INVOcell IVC stays in place (is retained within the vaginal cavity) while being used with the Retention Device during 5 days of continuous vaginal incubation.
Time Frame
5 days
Secondary Outcome Measure Information:
Title
Comfort
Description
Comfort of the INVOcell IVC while worn with the Retention Device evaluated on a 10-oint Likert scale.
Time Frame
5 days
Title
Vaginal tissue reactions
Description
Vaginal tissue reactions during the vaginal incubation based on post removal and assessed by vaginal speculum examination performed to examine the vaginal walls speculum examination post removal vaginal examination.
Time Frame
5 days
Title
Optical clarity
Description
Optical clarity and the ability to visualize the embryos after the incubation of the INVOcell device.
Time Frame
5 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Have been informed about the study and have given their written consent. Patients 18 years to 42 years Women who are scheduled for an oocyte retrieval in anticipation of INVOcell IVF. Exclusion Criteria: Inability to read and speak English fluently Identified vaginal infection Recent pelvic surgery based on clinical history and physical examination. History of toxic shock syndrome Inability to tolerate the placement or wearing of the INVOcell IVC or INVOcell Retention Device. Inability to tolerate a speculum examination Unwilling or unable to wear the INVO Retention (diaphragm) during the incubation. Unable or unwilling to sign informed consent or abide by study follow up assessment requirements.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen Hammond, DNP, CRNP
Organizational Affiliation
American Institute of Reproductive Medicine/IVD Alabama (AIRM)
Official's Role
Principal Investigator
Facility Information:
Facility Name
American Institute of Reproductive Medicine/IVF Alabama (AIRM)
City
Homewood
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Assessment of the INVOcell Culture Device When Used for up to Five-Day Incubation

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