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

INVO Bioscience

Status: Completed

Conditions: Infertility

Treatments: Device: INVOcell

Study type: Interventional

Funder types: Industry

Identifiers

NCT04644380

CP-018

Details and patient eligibility

About

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.

Full 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

Enrollment: 31 patients

Sex: Female

Ages: 18 to 42 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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31 participants in 1 patient group

Treatment Group

Experimental group

Description:

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

Treatment:

Device: INVOcell