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Assessment of the INVOcell Culture Device When Used for up to Five-Day Incubation

NCT04644380 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2021-02-17

No results posted yet for this study

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 and vaginal irritation as secondary endpoints.

Conditions

Interventions

DEVICE

INVOcell

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

Sponsors & Collaborators

  • INVO Bioscience, Inc.

    lead INDUSTRY

Principal Investigators

  • Karen Hammond, DNP, CRNP · American Institute of Reproductive Medicine/IVD Alabama (AIRM)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
42 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-12-02
Primary Completion
2020-12-11
Completion
2020-12-11
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04644380 on ClinicalTrials.gov