InfertilityNCT04644380
Assessment of the INVOcell Culture Device When Used for up to Five-Day Incubation
A study testing INVOcell in people with Infertility, run by INVO Bioscience, Inc. at 1 site in United States.
Trial summary
The INVOcell Culture Device received de novo request for 3-day intravaginal incubation. The device is held in place with the intravaginal cavity by a Retention Device. The clinical study will assess the ability of a modified Retention Device to hold INVOcell in place during 5-day vaginal incubation as well as comfort… Read more about this study
- Who is it for?
- Ages 18 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- INVOcell
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Dec 2020to 11 Dec 2020
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Have been informed about the study and have given their written consent.
- Patients 18 years to 42 years
- Women who are scheduled for an oocyte retrieval in anticipation of INVOcell IVF.
Who cannot join
- Inability to read and speak English fluently
- Identified vaginal infection
- Recent pelvic surgery based on clinical history and physical examination.
- History of toxic shock syndrome
- Inability to tolerate the placement or wearing of the INVOcell IVC or INVOcell Retention Device.
- Inability to tolerate a speculum examination
- Unwilling or unable to wear the INVO Retention (diaphragm) during the incubation.
- Unable or unwilling to sign informed consent or abide by study follow up assessment requirements.
Trial locations and contacts
1 site in 1 country.
United States1 site
American Institute of Reproductive Medicine/IVF Alabama (AIRM)
Homewood, Alabama, 35209
About this study
The INVOcell Culture Device received de novo request for 3-day intravaginal incubation. The device is held in place with the intravaginal cavity by a Retention Device. The clinical study will assess the ability of a modified Retention Device to hold INVOcell in place during 5-day vaginal incubation as well as comfort and vaginal irritation as secondary endpoints.
Read the detailed description
This is a single center, open label non-comparative prospective trial to evaluate the retention of the INVOcell IVC with the Retention Device over the vaginal incubation period of up to 5 days.
The purpose of this study is to assess the retention of the INVOcell IVC device with the Retention Device over the vaginal incubation period of up to 5 days.
Primary Endpoint
- Retention of the INVOcell IVC device with the Retention Device over the vaginal incubation period of up to 5 days.
Secondary Endpoint
- Comfort of the INVOcell IVC and Retention Device
- Vaginal tissue reactions during the vaginal incubation
- Optical clarity and the ability to visualize the embryos after the incubation
- Conditions
- Infertility
- Being tested
- INVOcell
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INVOcellDevice
Also called Intravaginal Culture, IVC, Vaginal incubation
Female participants undergoing in vitro fertilization (IVF) and or/or Intracytoplasmic Sperm Injection (ICSI) for assisted reproductive will be asked to participate
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | During an IVF/IVC cycle, participants will retain the INVOcell Culture Device with the Retention Device in the vaginal cavity for 5 days vaginal incubation Receives: Device: INVOcell |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device Retention
The primary endpoint is INVOcell IVC retention with the Retention Device. The following will be assessed:
Whether the INVOcell IVC stays in place (is retained within the vaginal cavity) while being used with the Retention Device during 5 days of continuous vaginal incubation.
Measured: 5 days
Secondary outcomes (3)
Comfort
Comfort of the INVOcell IVC while worn with the Retention Device evaluated on a 10-oint Likert scale.
Measured: 5 days
Vaginal tissue reactions
Vaginal tissue reactions during the vaginal incubation based on post removal and assessed by vaginal speculum examination performed to examine the vaginal walls speculum examination post removal vaginal examination.
Measured: 5 days
Optical clarity
Optical clarity and the ability to visualize the embryos after the incubation of the INVOcell device.
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 posted25 Nov 2020
- Study start2 Dec 2020
- Primary completion11 Dec 2020
- Study completion11 Dec 2020
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- INVO Bioscience, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Karen Hammond, DNP, CRNP, Principal investigator, American Institute of Reproductive Medicine/IVD Alabama (AIRM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04644380
- Sponsor's protocol ID
- CP-018
- Status last verified
- Feb 2021
- First submitted
- 20 Nov 2020
- Last updated
- 17 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the INVOcell Culture Device When Used for up to Five-Day Incubation
- ClinicalTrials.gov ID
- NCT04644380
- Acronym / sponsor ID
- CP-018
- Conditions
- Infertility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- INVO Bioscience, Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Dec 2020 (actual)
- Primary completion
- 11 Dec 2020 (actual)
- Study completion
- 11 Dec 2020 (actual)
- First posted
- 25 Nov 2020 (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.
The INVOcell Culture Device received de novo request for 3-day intravaginal incubation. The device is held in place with the intravaginal cavity by a Retention Device. The clinical study will assess the ability of a modified Retention Device to hold INVOcell in place during 5-day vaginal incubation as well as comfort and vaginal irritation as secondary endpoints.
Detailed description
This is a single center, open label non-comparative prospective trial to evaluate the retention of the INVOcell IVC with the Retention Device over the vaginal incubation period of up to 5 days.
The purpose of this study is to assess the retention of the INVOcell IVC device with the Retention Device over the vaginal incubation period of up to 5 days.
Primary Endpoint
- Retention of the INVOcell IVC device with the Retention Device over the vaginal incubation period of up to 5 days.
Secondary Endpoint
- Comfort of the INVOcell IVC and Retention Device
- Vaginal tissue reactions during the vaginal incubation
- Optical clarity and the ability to visualize the embryos after the incubation
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Device: INVOcellDuring an IVF/IVC cycle, participants will retain the INVOcell Culture Device with the Retention Device in the vaginal cavity for 5 days vaginal incubation |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Have been informed about the study and have given their written consent.
- Patients 18 years to 42 years
- Women who are scheduled for an oocyte retrieval in anticipation of INVOcell IVF.
Key exclusion criteria (8 listed)
- Inability to read and speak English fluently
- Identified vaginal infection
- Recent pelvic surgery based on clinical history and physical examination.
- History of toxic shock syndrome
- Inability to tolerate the placement or wearing of the INVOcell IVC or INVOcell Retention Device.
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 |
|---|---|---|
| INVOcellAlso: Intravaginal Culture, IVC, Vaginal incubationFemale participants undergoing in vitro fertilization (IVF) and or/or Intracytoplasmic Sperm Injection (ICSI) for assisted reproductive will be asked to participate | Device | Treatment Group |
Primary outcome
Device Retention
Time frame: 5 days
The primary endpoint is INVOcell IVC retention with the Retention Device. The following will be assessed: Whether the INVOcell IVC stays in place (is retained within the vaginal cavity) while being used with the Retention Device during 5 days of continuous vaginal incubation.
3 secondary outcomes
Comfort
Time frame: 5 days
Vaginal tissue reactions
Time frame: 5 days
Optical clarity
Time frame: 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2021.
- Individual participant dataSharing planned: No
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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.
Karen Hammond, DNP, CRNP principal investigator
American Institute of Reproductive Medicine/IVD Alabama (AIRM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing INVOcell in people with Infertility, run by INVO Bioscience, Inc. at 1 site 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 3 inclusion and 8 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: finished, as of the sponsor's last update on 17 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Device Retention (time frame: 5 days). 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 17 Feb 2021.