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

NCT04644380 | Completed FDA Device

• 1 other identifier: CP-018
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Comfort

  5 days

• Vaginal tissue reactions

  5 days

• Optical clarity

  5 days

Study Arms (1)

Treatment Group

EXPERIMENTAL

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

Interventions

INVOcell DEVICE

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

Also known as: Intravaginal Culture, IVC, Vaginal incubation

Treatment Group

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• INVO Bioscience, Inc.: lead

Study Sites (1)

American Institute of Reproductive Medicine/IVF Alabama (AIRM)

Homewood, Alabama, 35209, United States

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Karen Hammond, DNP, CRNP

  American Institute of Reproductive Medicine/IVD Alabama (AIRM)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2020
• First Posted: November 25, 2020
• Study Start: December 2, 2020
• Primary Completion: December 11, 2020
• Study Completion: December 11, 2020
• Last Updated: February 17, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)