InfertilityNCT04246268
Assessment of the INVOcell Intravaginal Culture System
A study testing INVOcell in people with Infertility, run by INVO Bioscience, Inc. at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 37 years, women only
- 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
- 180 participants
- Where
- 4 sitesUnited States
- Study dates
- Oct 2020to Mar 2022
- 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 37 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women diagnosed with:
- Tubal factor
- Endometriosis (stage I or II)
- Ovulatory dysfunction
- Multiple female factors
- Males with mild male factor [mild male factor is defined as meaning: two or more semen analyses that have one or more variables which fall below the 5th centile as defined by the World Health Organization (WHO, 2010)]
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- Couples with:
- Unexplained Infertility
- Multiple factors, of female and/or male origin
- The pre-selected couples will be included in the study only if they fulfill the more specific inclusion and exclusion criteria below:
- Couples may be included in the study only if they have been informed about the study and have given their written consent.
- Infertile couples with failure to conceive a diagnosed pregnancy after one year of unprotected intercourse (6 months if the woman's age is 35 years or more). This one-year requirement need not be fulfilled if oligomenorrhea or tubal factor is present, or donor sperm use is planned
- IVF has been determined by the physician to be their next appropriate treatment
- Women with desire for pregnancy using donor sperm will be eligible even absent infertility factors.
- Women included in the study should:
- Be between the age of 18 and 37 years (has not reached her 38th birthday at the time of enrollment).
- Have an anti-Müllerian hormone (AMH) level ≥ 0.8 ng/mL
- Have a normal uterine cavity as assessed in the past year by HSG, SHG or hysteroscopy. Prior tubal ligation is acceptable.
- Partner semen analysis within the past year must show a total of ≥ 15 million motile spermatozoa.
Who cannot join
- Inability to read and speak English fluently
- One (1) or more recurrent vaginitis or bacterial vaginosis (BV) requiring medical attention.
- A history of toxic shock syndrome
- Known allergies to plastic or silicone
- Had pelvic surgery within the past 8 weeks, excluding laparoscopy with or without salpingectomy (ies) or hysteroscopy with or without polypectomy
- Had pelvic inflammatory disease (PID) within the past 3 months and were treated with antibiotics
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- Severe endometriosis (stage III-IV) or endometrioma(s) (past or present)
- Clinical signs of current vaginal infection
- Significant abnormalities of the vaginal cavity
- Submucous or intramural fibroids (>2 cm diameter)
- Hydrosalpinx
- Uncontrolled chronic illness, e.g. autoimmune disease, diabetes. Appropriately treated hypothyroidism, hypertension, dyslipidemia, e.g., are not exclusions.
- BMI >36.0 kg/m2
- Donor oocytes
- Antral follicle count (AFC; at cycle baseline) < 6
- Previously assessed as having a poor response to ovarian stimulation
- Patients with polycystic ovary syndrome (PCOS) meeting NIH (1990) criteria
- Cervical stenosis
- Recurrent pregnancy loss defined by recurrent non-biochemical pregnancy losses
- Failed fertilization of all oocytes obtained in a previous IVF cycle
- Smoke tobacco or vape, abuse drugs or alcohol
- Inability to understand or comply with trial procedures
- Partner with vasectomy reversal
- Partner with inability to produce sperm specimen
- Partner with uro-genital infection
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Piedmont Reproductive Endocrinology Group
Greenville, South Carolina, 29615
Fertility Center of San Antonio
San Antonio, Texas, 78229
The New Hope Center for Reproductive Medicine
Virginia Beach, Virginia, 23452
Piedmont Reproductive Endocrinology Group
West Columbia, South Carolina, 29169
About this study
Official title: Assessment of the INVOcell Intravaginal Culture System During 5-day (120 Hours) Vaginal Incubation
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:
Read more
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.
Read the 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:
- 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.
- The Retention Device retains the INVOcell in the vaginal cavity and is well tolerated during the 5-days of continuous vaginal 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 Intracytoplasmic Sperm Injection (ICSI) for assisted reproduction will be asked to participate.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Device: INVOcell Intravaginal Culture System
Intervention: 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.
Clinical Pregnancy Rate
Clinical pregnancy rate: number of clinical pregnancies at 7 weeks of gestation divided by the number of successful egg retrieval procedures.
Measured: at 7 weeks of gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2020
- Study startOct 2020 (estimated)
- Primary completionJul 2021 (estimated)
- Study completionMar 2022 (estimated)
Why it stopped: INVO Bioscience is suspending trial per ASRM's recommendations during Covid-19 pandemic.
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
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- INVO Bioscience, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ferring Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Kevin Doody, MD, Study director, INVO Bioscience, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04246268
- Sponsor's protocol ID
- CP-017
- Status last verified
- Jul 2020
- First submitted
- 27 Jan 2020
- Last updated
- 28 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is not a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the INVOcell Intravaginal Culture System During 5-day (120 Hours) Vaginal Incubation
- ClinicalTrials.gov ID
- NCT04246268
- Acronym / sponsor ID
- CP-017
- Conditions
- Infertility
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: INVO Bioscience is suspending trial per ASRM's recommendations during Covid-19 pandemic.
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- INVO Bioscience, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Ferring Pharmaceuticals
- Study start
- Oct 2020 (estimated)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 29 Jan 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 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:
- 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.
- The Retention Device retains the INVOcell in the vaginal cavity and is well tolerated during the 5-days of continuous vaginal 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: INVOcellDevice: INVOcell Intravaginal Culture System Intervention: 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. |
Who may qualify
- Ages
- 18 to 37 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (19 listed)
- Tubal factor
- Endometriosis (stage I or II)
- Ovulatory dysfunction
- Multiple female factors
- Males with mild male factor [mild male factor is defined as meaning: two or more semen analyses that have one or more variables which fall below the 5th centile as defined by the World Health Organization (WHO, 2010)]
Key exclusion criteria (25 listed)
- Inability to read and speak English fluently
- One (1) or more recurrent vaginitis or bacterial vaginosis (BV) requiring medical attention.
- A history of toxic shock syndrome
- Known allergies to plastic or silicone
- Had pelvic surgery within the past 8 weeks, excluding laparoscopy with or without salpingectomy (ies) or hysteroscopy with or without polypectomy
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 Intracytoplasmic Sperm Injection (ICSI) for assisted reproduction will be asked to participate. | Device | Treatment Group |
Primary outcome
Clinical Pregnancy Rate
Time frame: at 7 weeks of gestation
Clinical pregnancy rate: number of clinical pregnancies at 7 weeks of gestation divided by the number of successful egg retrieval procedures.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2020.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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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.
Kevin Doody, MD study director
INVO Bioscience, Inc.
4 sites 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 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 19 inclusion and 25 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: paused, as of the sponsor's last update on 28 Jul 2020. 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?
Clinical Pregnancy Rate (time frame: at 7 weeks of gestation). 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 28 Jul 2020.