Infertility
Conditions
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
Interventions
DEVICEINVOcell
Female participants undergoing in vitro fertilization (IVF) and or/or Intracytoplasmic Sperm Injection (ICSI) for assisted reproductive will be asked to participate
Sponsors
INVO Bioscience, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 42 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Device Retention | 5 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comfort | 5 days | Comfort of the INVOcell IVC while worn with the Retention Device evaluated on a 10-oint Likert scale. |
| Vaginal tissue reactions | 5 days | 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. |
| Optical clarity | 5 days | Optical clarity and the ability to visualize the embryos after the incubation of the INVOcell device. |
Countries
United States
Outcome results
None listed