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Assessment of the INVOcell Intravaginal Culture System

Primary Purpose

Infertility

Status
Suspended
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
INVOcell
Sponsored by
INVO Bioscience, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility

Eligibility Criteria

18 Years - 37 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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)]

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.

Exclusion Criteria:

  • 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
  • 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

Sites / Locations

  • Piedmont Reproductive Endocrinology Group
  • Piedmont Reproductive Endocrinology Group
  • Fertility Center of San Antonio
  • The New Hope Center for Reproductive Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment Group

Arm Description

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.

Outcomes

Primary Outcome Measures

Clinical Pregnancy Rate
Clinical pregnancy rate: number of clinical pregnancies at 7 weeks of gestation divided by the number of successful egg retrieval procedures.

Secondary Outcome Measures

Full Information

First Posted
January 27, 2020
Last Updated
July 27, 2020
Sponsor
INVO Bioscience, Inc.
Collaborators
Ferring Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT04246268
Brief Title
Assessment of the INVOcell Intravaginal Culture System
Official Title
Assessment of the INVOcell Intravaginal Culture System During 5-day (120 Hours) Vaginal Incubation
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Suspended
Why Stopped
INVO Bioscience is suspending trial per ASRM's recommendations during Covid-19 pandemic.
Study Start Date
October 2020 (Anticipated)
Primary Completion Date
July 2021 (Anticipated)
Study Completion Date
March 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
INVO Bioscience, Inc.
Collaborators
Ferring Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief 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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
INVOcell
Other Intervention Name(s)
Intravaginal Culture, IVC, Vaginal Incubation
Intervention Description
Female participants undergoing in vitro fertilization (IVF) and/or Intracytoplasmic Sperm Injection (ICSI) for assisted reproduction will be asked to participate.
Primary Outcome Measure Information:
Title
Clinical Pregnancy Rate
Description
Clinical pregnancy rate: number of clinical pregnancies at 7 weeks of gestation divided by the number of successful egg retrieval procedures.
Time Frame
at 7 weeks of gestation

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
37 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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)] 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. Exclusion Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin Doody, MD
Organizational Affiliation
INVO Bioscience, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Piedmont Reproductive Endocrinology Group
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Piedmont Reproductive Endocrinology Group
City
West Columbia
State/Province
South Carolina
ZIP/Postal Code
29169
Country
United States
Facility Name
Fertility Center of San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
The New Hope Center for Reproductive Medicine
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23452
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is not a plan to make IPD available.

Learn more about this trial

Assessment of the INVOcell Intravaginal Culture System

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