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

Sponsor
INVO Bioscience, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT04644380
Collaborator
(none)
31
Enrollment
1
Location
1
Arm
9
Actual Duration (Days)
104.8
Patients Per Site Per Month

Study Details

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
  • Device: INVOcell
 N/A

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
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 :
Dec 2, 2020
Actual Primary Completion Date :
Dec 11, 2020
Actual Study Completion Date :
Dec 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 [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 [5 days]

      Comfort of the INVOcell IVC while worn with the Retention Device evaluated on a 10-oint Likert scale.

    2. Vaginal tissue reactions [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 [5 days]

      Optical clarity and the ability to visualize the embryos after the incubation of the INVOcell device.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 42 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Site City State Country Postal Code
    1 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)

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    INVO Bioscience, Inc.
    ClinicalTrials.gov Identifier:
    NCT04644380
    Other Study ID Numbers:
    • CP-018
    First Posted:
    Nov 25, 2020
    Last Update Posted:
    Feb 17, 2021
    Last Verified:
    Feb 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    Infertility

    Study Results

    No Results Posted as of Feb 17, 2021