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

NCT ID: NCT04644380

Last Updated: 2021-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-02
• Study Completion Date: 2020-12-11

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

Conditions

Infertility

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

INVOcell

Intervention Type: DEVICE

Female participants undergoing in vitro fertilization (IVF) and or/or Intracytoplasmic Sperm Injection (ICSI) for assisted reproductive will be asked to participate

Interventions

INVOcell

Female participants undergoing in vitro fertilization (IVF) and or/or Intracytoplasmic Sperm Injection (ICSI) for assisted reproductive will be asked to participate

Intervention Type: DEVICE

Other Intervention Names

Intravaginal Culture; IVC; Vaginal incubation

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 42 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

INVO Bioscience, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karen Hammond, DNP, CRNP

Role: PRINCIPAL_INVESTIGATOR

American Institute of Reproductive Medicine/IVD Alabama (AIRM)

Locations

American Institute of Reproductive Medicine/IVF Alabama (AIRM)

Homewood, Alabama, United States

Countries

United States

Other Identifiers

CP-018

Identifier Type: -

Identifier Source: org_study_id