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

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04644380
• Other study ID #: CP-018
• Status: Completed
• Phase: N/A
• Start date: December 2, 2020
• Est. completion date: December 11, 2020

Study information

• Verified date: February 2021
• Source: INVO Bioscience, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: December 11, 2020
• Est. primary completion date: December 11, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infertility

Intervention

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

Locations

Country	Name	City	State
United States	American Institute of Reproductive Medicine/IVF Alabama (AIRM)	Homewood	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
INVO Bioscience, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Comfort	Comfort of the INVOcell IVC while worn with the Retention Device evaluated on a 10-oint Likert scale.	5 days
Secondary	Vaginal tissue reactions	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.	5 days
Secondary	Optical clarity	Optical clarity and the ability to visualize the embryos after the incubation of the INVOcell device.	5 days