NCT05189405

Brief Summary

Retrospective chart review of data on the use of traditional IVF and INVOcell IVC collected from clinics using both technologies. The retrospective data will be utilized for a comparison of the two methods.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
450

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2021

Shorter than P25 for all trials

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 12, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 29, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 12, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2022

Completed
Last Updated

January 12, 2022

Status Verified

December 1, 2021

Enrollment Period

5 months

First QC Date

December 29, 2021

Last Update Submit

December 29, 2021

Conditions

Infertility

Outcome Measures

Primary Outcomes (3)

  • Embryo development

    Characteristics of embryo quality and phase of development and transfer rates

    5 days

  • Clinical pregnancy rate

    Clinical pregnancy rate

    5 days

  • Live birth rate

    Live birth rate

    5 days

Secondary Outcomes (2)

  • Maternal Adverse Events

    5 days

  • Offspring adverse events

    5 days

Study Arms (2)

INVOcell IVC

IVF using intravaginal incubation with INVOcell device for embryo development.

Device: INVOcell IVC

Traditional IVF (tIVF)

Traditional IVF using laboratory equipment and incubators for embryo development

Interventions

INVOcell IVCDEVICE

Embryo development in intravaginal incubation

INVOcell IVC

Eligibility Criteria

Age18 Years - 42 Years
Sexfemale
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Subjects that have received infertility treatment with either INVOcell IVC or standard IVF during the same timeframe. All subjects treated with the standard of care IVF method during the same timeframe that the center used INVOcell IVC were included in the retrospective data collection.

You may qualify if:

  • Subjects that have received infertility treatment with either INVOcell IVC or standard IVF during the same timeframe. All subjects treated with the standard of care IVF method during the same timeframe that the center used INVOcell IVC were included in the retrospective data collection.

You may not qualify if:

  • Not applicable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Carolina Conceptions

Raleigh, North Carolina, 27607, United States

Location

Piedmont Reproductive Endocrinology Group

Greenville, South Carolina, 29615, United States

Location

CARE Fertility

Bedford, Texas, 76022, 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 DiseasesUrogenital Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 29, 2021

First Posted

January 12, 2022

Study Start

October 12, 2021

Primary Completion

February 28, 2022

Study Completion

February 28, 2022

Last Updated

January 12, 2022

Record last verified: 2021-12

Locations

US(4)