NCT04246268

Assessment of the INVOcell Intravaginal Culture System

Assessment of the INVOcell Intravaginal Culture System During 5-day (120 Hours) Vaginal Incubation

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: INVO Bioscience, Inc. · Industry
• Sex: Female
• Age: 18 Years – 37 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Infertility

Interventions

Type	Name	Description
DEVICE	INVOcell	Female participants undergoing in vitro fertilization (IVF) and/or Intracytoplasmic Sperm Injection (ICSI) for assisted reproduction will be asked to participate.

Timeline

• Start date: 2020-10-01
• Primary completion: 2021-07-01
• Completion: 2022-03-01
• First posted: 2020-01-29
• Last updated: 2020-07-28

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study