Ignite Creation Date:
2025-12-24 @ 5:55 PM
Ignite Modification Date:
2026-01-09 @ 7:54 AM
Study NCT ID:
NCT04246268
Status:
SUSPENDED
Last Update Posted:
2020-07-28
First Post:
2020-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of the INVOcell Intravaginal Culture System
Sponsor:
INVO Bioscience, Inc.
Organization:
Study Overview
Official Title:
Assessment of the INVOcell Intravaginal Culture System During 5-day (120 Hours) Vaginal Incubation
Status:
SUSPENDED
Status Verified Date:
2020-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
INVO Bioscience is suspending trial per ASRM's recommendations during Covid-19 pandemic.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The INVOcell intravaginal culture system is a prescription device intended for preparing, holding, and transferring human gametes or embryos during intravaginal in vitro fertilization or intravaginal culture procedures.
The original (FG-002) INVOcell culture system was FDA cleared through De Novo application (DEN150008). The purpose of this study is to evaluate the INVO Bioscience modified INVOcell system, comprised of the INVOcell Intravaginal Culture Device and Retention Device, in terms of the following:
2.1 Effectiveness of achieving fertilization, implantation, embryo development, clinical pregnancy, and live birth after 5-days of continuous vaginal incubation.
2.2 The comfort and retention of the INVOcell device and retention system intravaginally.
The original (FG-002) INVOcell culture system was FDA cleared through De Novo application (DEN150008). The purpose of this study is to evaluate the INVO Bioscience modified INVOcell system, comprised of the INVOcell Intravaginal Culture Device and Retention Device, in terms of the following:
2.1 Effectiveness of achieving fertilization, implantation, embryo development, clinical pregnancy, and live birth after 5-days of continuous vaginal incubation.
2.2 The comfort and retention of the INVOcell device and retention system intravaginally.
Detailed Description:
This is a Pivotal, single arm, multicenter, open label trial to evaluate the efficacy, comfort and retention of the INVOcell Intravaginal Culture Device and Retention Device over 5-days vaginal incubation. The effectiveness of the INVOcell device will be tested on a select population of infertile couples at several in vitro fertilization (IVF) centers. The providers at each center will conduct the processes of ovarian stimulation, egg retrieval and embryo transfer per the standard protocols for their centers. The planned sample size is 180 participants across 3 sites (60 participants per site).
The objective of this study is to assess the efficacy, comfort and retention of the INVOcell with the retention device, and demonstrate superiority following 5-day vaginal incubation as compared to current 3-day vaginal incubation indication.
Specifically, the following will be assessed:
1. The INVO Procedure using the INVOcell Intravaginal Culture Device can effectively maintain 5-days of continuous vaginal incubation with the transfer of blastocyst(s) at the end of the 5-days.
2. The Retention Device retains the INVOcell in the vaginal cavity and is well tolerated during the 5-days of continuous vaginal incubation.
The objective of this study is to assess the efficacy, comfort and retention of the INVOcell with the retention device, and demonstrate superiority following 5-day vaginal incubation as compared to current 3-day vaginal incubation indication.
Specifically, the following will be assessed:
1. The INVO Procedure using the INVOcell Intravaginal Culture Device can effectively maintain 5-days of continuous vaginal incubation with the transfer of blastocyst(s) at the end of the 5-days.
2. The Retention Device retains the INVOcell in the vaginal cavity and is well tolerated during the 5-days of continuous vaginal incubation.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: