Assessment of the INVOcell Intravaginal Culture System
Public ClinicalTrials.gov record NCT04246268. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Assessment of the INVOcell Intravaginal Culture System During 5-day (120 Hours) Vaginal Incubation
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04246268
- Recruitment status
- Suspended
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 180 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 37 Years
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 30, 2020
- Primary completion
- Jun 30, 2021
- Completion
- Feb 28, 2022
- Last update posted
- Jul 27, 2020
2020 – 2022
United States locations
- U.S. sites
- 4
- U.S. states
- 3
- U.S. cities
- 4
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Piedmont Reproductive Endocrinology Group | Greenville | South Carolina | 29615 | — |
| Piedmont Reproductive Endocrinology Group | West Columbia | South Carolina | 29169 | — |
| Fertility Center of San Antonio | San Antonio | Texas | 78229 | — |
| The New Hope Center for Reproductive Medicine | Virginia Beach | Virginia | 23452 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04246268, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 27, 2020 · Synced Sep 6, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04246268 live on ClinicalTrials.gov.