Ignite Creation Date:
2025-12-25 @ 3:17 AM
Ignite Modification Date:
2025-12-26 @ 1:56 AM
Study NCT ID:
NCT05189405
Status:
UNKNOWN
Last Update Posted:
2022-01-12
First Post:
2021-12-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
3 Year Retrospective Analysis of IVF in Comparison With INVOcell
Sponsor:
INVO Bioscience, Inc.
Organization:
Study Overview
Official Title:
A 3 Year Retrospective Analysis of Fertility Clinic's of In Vitro Fertilization (IVF) in Comparison With INVOcell Intravaginal Culture (INVOcell IVC) Device
Status:
UNKNOWN
Status Verified Date:
2021-12
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
* 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: