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

• ClinicalTrials.gov Identifier: NCT04644380
• Recruitment Status: Completed
• First Posted: November 25, 2020
• Last Update Posted: February 17, 2021
• Sponsor: INVO Bioscience, Inc.
• Information provided by (Responsible Party): INVO Bioscience, Inc.

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.

Condition or disease	Intervention/treatment	Phase
Infertility	Device: INVOcell	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 31 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Assessment of the INVOcell Culture Device When Used for up to Five-Day Incubation
• Actual Study Start Date: December 2, 2020
• Actual Primary Completion Date: December 11, 2020
• Actual Study Completion Date: December 11, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Device Retention [ Time Frame: 5 days ]

   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 :

1. Comfort [ Time Frame: 5 days ]
   Comfort of the INVOcell IVC while worn with the Retention Device evaluated on a 10-oint Likert scale.
2. Vaginal tissue reactions [ Time Frame: 5 days ]
   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.
3. Optical clarity [ Time Frame: 5 days ]
   Optical clarity and the ability to visualize the embryos after the incubation of the INVOcell device.

Eligibility Criteria

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

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.

Contacts and Locations

Locations

United States, Alabama

American Institute of Reproductive Medicine/IVF Alabama (AIRM)

Homewood, Alabama, United States, 35209

Sponsors and Collaborators

INVO Bioscience, Inc.

Investigators

• Principal Investigator: Karen Hammond, DNP, CRNP; American Institute of Reproductive Medicine/IVD Alabama (AIRM)

More Information

• Responsible Party: INVO Bioscience, Inc.
• ClinicalTrials.gov Identifier: NCT04644380
• Other Study ID Numbers: CP-018
• First Posted: November 25, 2020
• Last Update Posted: February 17, 2021
• Last Verified: February 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Additional relevant MeSH terms:

Infertility