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

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.

Study Overview

• Status: Completed
• Conditions: Infertility
• Intervention / Treatment: Device: INVOcell

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

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Homewood, Alabama, United States, 35209
      • American Institute of Reproductive Medicine/IVF Alabama (AIRM)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 42 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Group; 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	Device: INVOcell; Female participants undergoing in vitro fertilization (IVF) and or/or Intracytoplasmic Sperm Injection (ICSI) for assisted reproductive will be asked to participate; Other Names: Intravaginal Culture; IVC; Vaginal incubation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	5 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comfort	Comfort of the INVOcell IVC while worn with the Retention Device evaluated on a 10-oint Likert scale.	5 days
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.	5 days
Optical clarity	Optical clarity and the ability to visualize the embryos after the incubation of the INVOcell device.	5 days

Collaborators and Investigators

• Sponsor: INVO Bioscience, Inc.
• Investigators: Principal Investigator: Karen Hammond, DNP, CRNP, American Institute of Reproductive Medicine/IVD Alabama (AIRM)

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2020
• Primary Completion (Actual): December 11, 2020
• Study Completion (Actual): December 11, 2020

Study Registration Dates

• First Submitted: November 20, 2020
• First Submitted That Met QC Criteria: November 20, 2020
• First Posted (Actual): November 25, 2020

Study Record Updates

• Last Update Posted (Actual): February 17, 2021
• Last Update Submitted That Met QC Criteria: February 16, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: CP-018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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.: Yes