Assessment of the INVOcell Intravaginal Culture System

NCT04246268 | Suspended FDA Device

• 1 other identifier: CP-017
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 4

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.

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

• Clinical Pregnancy Rate

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

  at 7 weeks of gestation

Study Arms (1)

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.

Device: INVOcell

Interventions

INVOcell DEVICE

Female participants undergoing in vitro fertilization (IVF) and/or Intracytoplasmic Sperm Injection (ICSI) for assisted reproduction will be asked to participate.

Also known as: Intravaginal Culture, IVC, Vaginal Incubation

Treatment Group

Eligibility Criteria

• Age: 18 Years - 37 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• INVO Bioscience, Inc.: lead
• Ferring Pharmaceuticals: collaborator

Study Sites (4)

Piedmont Reproductive Endocrinology Group

Greenville, South Carolina, 29615, United States

Location

Piedmont Reproductive Endocrinology Group

West Columbia, South Carolina, 29169, United States

Location

Fertility Center of San Antonio

San Antonio, Texas, 78229, United States

Location

The New Hope Center for Reproductive Medicine

Virginia Beach, Virginia, 23452, United States

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Kevin Doody, MD

  INVO Bioscience, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2020
• First Posted: January 29, 2020
• Study Start: October 1, 2020
• Primary Completion: July 1, 2021
• Study Completion: March 1, 2022
• Last Updated: July 28, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)