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

Completed · Not applicable

Conditions studied: Infertility

In brief

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.

Key facts

Study ID

NCT04644380

Run by

INVO Bioscience, Inc.

People needed

31

Starts

2020-12-02

Expected to finish

2020-12-11

Last updated by the study team

2021-02-17

Who can join

Age: 18 and older, up to 42. Sex: female. Healthy volunteers: accepted.

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.

Where it is running

• American Institute of Reproductive Medicine/IVF Alabama (AIRM) — Homewood, Alabama, United States

Full record on ClinicalTrials.gov

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