Infertility
Conditions
Brief summary
Retrospective chart review of data on the use of traditional IVF and INVOcell IVC collected from clinics using both technologies. The retrospective data will be utilized for a comparison of the two methods.
Detailed description
The following aspects of data will be collected to support the analysis of the two methods * Procedure details for including oil overlay and incubation time frame * Characteristics of embryo quality and phase of development and transfer rates * Clinical pregnancy rate * Live birth rate Secondary: Data regarding safety * Adverse events noted by the women that received IVF and INVOcell IVC * Adverse events noted for the offspring
Interventions
DEVICEINVOcell IVC
Embryo development in intravaginal incubation
Sponsors
INVO Bioscience, Inc.
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 42 Years
Inclusion criteria
* Subjects that have received infertility treatment with either INVOcell IVC or standard IVF during the same timeframe. All subjects treated with the standard of care IVF method during the same timeframe that the center used INVOcell IVC were included in the retrospective data collection.
Exclusion criteria
* Not applicable
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Embryo development | 5 days | Characteristics of embryo quality and phase of development and transfer rates |
| Clinical pregnancy rate | 5 days | Clinical pregnancy rate |
| Live birth rate | 5 days | Live birth rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maternal Adverse Events | 5 days | Adverse events noted by the women that received IVF and INVOcell IVC |
| Offspring adverse events | 5 days | Adverse events noted for the offspring |
Countries
United States
Outcome results
None listed