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OpenTrials
Completed

NCT Number: NCT04644380

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.

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

18 year–42 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

American Institute of Reproductive Medicine/IVF Alabama (AIRM)

Homewood, Alabama, 35209, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

INVOcell

Device

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

INVO Bioscience, Inc.

Industry

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Nov 25, 2020
Registry last updated
Feb 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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