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

Study Overview
=================
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

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

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Device: INVOcell


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 42 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group<br>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<br>* Female participants undergoing in vitro fertilization (IVF) and or/or Intracytoplasmic Sperm Injection (ICSI) for assisted reproductive will be asked to participate<br>* Other names: Vaginal incubation;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comfort | Comfort of the INVOcell IVC while worn with the Retention Device evaluated on a 10-oint Likert scale. | 5 days | 
| 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 | 
| Optical clarity | Optical clarity and the ability to visualize the embryos after the incubation of the INVOcell device. | 5 days |