InfertilityNCT05189405
3 Year Retrospective Analysis of IVF in Comparison With INVOcell
An observational study of Infertility, run by INVO Bioscience, Inc. at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- INVOcell IVC
- Type of treatment
- Medical device
- How many people
- 450 participants
- Where
- 4 sitesUnited States
- Study dates
- 12 Oct 2021to 28 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 42 years
- Women only
- Adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- Not applicable
Trial locations and contacts
4 sites in 1 country.
United States4 sites
CARE Fertility
Bedford, Texas, 76022
Piedmont Reproductive Endocrinology Group
Greenville, South Carolina, 29615
Carolina Conceptions
Raleigh, North Carolina, 27607
THE NEW HOPE CENTER for Reproductive Medicine
Virginia Beach, Virginia, 23452
About this study
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
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.
Read the 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
- Conditions
- Infertility
- Being tested
- INVOcell IVC
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INVOcell IVCDevice
Embryo development in intravaginal incubation
| Study group | Role | What they receive |
|---|---|---|
| INVOcell IVC | IVF using intravaginal incubation with INVOcell device for embryo development. Receives: Device: INVOcell IVC | |
| Traditional IVF (tIVF) | Traditional IVF using laboratory equipment and incubators for embryo development |
What is being measured
The primary outcome is the main question the study is designed to answer.
Embryo development
Characteristics of embryo quality and phase of development and transfer rates
Measured: 5 days
Clinical pregnancy rate
Clinical pregnancy rate
Measured: 5 days
Live birth rate
Live birth rate
Measured: 5 days
Secondary outcomes (2)
Maternal Adverse Events
Adverse events noted by the women that received IVF and INVOcell IVC
Measured: 5 days
Offspring adverse events
Adverse events noted for the offspring
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2022
- Study start12 Oct 2021
- Primary completion28 Feb 2022 (estimated)
- Study completion28 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- INVO Bioscience, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05189405
- Sponsor's protocol ID
- CP-019
- Status last verified
- Dec 2021
- First submitted
- 29 Dec 2021
- Last updated
- 12 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05189405
- Acronym / sponsor ID
- CP-019
- Conditions
- Infertility
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- INVO Bioscience, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Oct 2021 (actual)
- Primary completion
- 28 Feb 2022 (estimated)
- Study completion
- 28 Feb 2022 (estimated)
- First posted
- 12 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| INVOcell IVC | – | Device: INVOcell IVCIVF using intravaginal incubation with INVOcell device for embryo development. |
| Traditional IVF (tIVF) | – | –Traditional IVF using laboratory equipment and incubators for embryo development |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Not applicable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INVOcell IVCEmbryo development in intravaginal incubation | Device | INVOcell IVC |
Primary outcome
Embryo development
Time frame: 5 days
Characteristics of embryo quality and phase of development and transfer rates
Clinical pregnancy rate
Time frame: 5 days
Clinical pregnancy rate
Live birth rate
Time frame: 5 days
Live birth rate
2 secondary outcomes
Maternal Adverse Events
Time frame: 5 days
Offspring adverse events
Time frame: 5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, run by INVO Bioscience, Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Embryo development (time frame: 5 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2022.