Brief Summary

The purpose of this study is to record and evaluate the use of traditional morphology grading combined with Eeva in the treatment of in vitro fertilization.

Trial Health

At Risk

Trial Health Score

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

Trial has exceeded expected completion date

Enrollment

1,200

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Feb 2013

Typical duration for all trials

Geographic Reach

1 country

12 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

2.3 years study duration

Study Start

First participant enrolled

February 1, 2013

Completed

2 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2013

Completed

2 days until next milestone

First Posted

Study publicly available on registry

March 22, 2013

Completed

2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed

Last Updated

March 26, 2015

Status Verified

March 1, 2015

Enrollment Period

2.3 years

First QC Date

March 20, 2013

Last Update Submit

March 25, 2015

Conditions

Infertility

Keywords

In vitro fertilizationAssisted reproductive therapyTime-lapse image recordingImage analysis software

Outcome Measures

Primary Outcomes (1)

Clinical Pregnancy Rate
Determined by first pregnancy ultrasound outcome and optional 12-month phone follow-up
5-6 gestational weeks

Other Outcomes (2)

Multiple Pregnancy Rate
5-6 gestational weeks
Spontaneous Miscarriage Rate
5-6 gestational weeks

Study Arms (1)

In-vitro fertilization using Eeva

Patients undergoing in-vitro fertilization treatment who provide informed consent and use Eeva in their treatment cycle.

Device: In-vitro fertilization using Eeva

Interventions

In-vitro fertilization using EevaDEVICE

Eeva will image embryos through cleavage stage (Day 3). Embryologists will use Eeva results along with traditional morphological grading to assist in selecting embryo(s) for transfer or freezing.

In-vitro fertilization using Eeva

Eligibility Criteria

Sexfemale

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Patients undergoing in vitro fertilization treatment who provide informed consent and use Eeva in their treatment cycle.

You may qualify if:

women undergoing fresh in vitro fertilization treatment using their own eggs or donor eggs.

You may not qualify if:

history of cancer.
gestational carrier.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Progyny, Inc.lead

Study Sites (12)

HRC Fertility

Encino, California, 91436, United States

Location

Stanford Fertility and Reproductive Medicine Center

Palo Alto, California, 94304, United States

Location

Reproductive Partners

Redondo Beach, California, 90277, United States

Location

Pacific Fertility Center

San Francisco, California, 95124, United States

Location

Center for Advanced Reproductive Services (UCHC)

Farmington, Connecticut, 06030, United States

Location

Fertility Centers of Illinois - River North

Chicago, Illinois, 60610, United States

Location

Northwestern Medical Faculty Foundation

Chicago, Illinois, 60611, United States

Location

Fertility Centers of Illinois, Highland Park IVF Center

Highland Park, Illinois, 60035, United States

Location

Long Island IVF

Melville, New York, 11747, United States

Location

University Hospital Fertility Center

Beachwood, Ohio, 44122, United States

Location

Institute for Reproductive Health

Cincinnati, Ohio, 45209, United States

Location

Fertility Center of San Antonio

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

Shehua Shen, MD
Progyny, Inc.
STUDY DIRECTOR

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Target Duration: 12 Months
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

March 20, 2013

First Posted

March 22, 2013

Study Start

February 1, 2013

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

March 26, 2015

Record last verified: 2015-03

Locations

US(12)

Registry Study of Traditional Morphology Grading Combined With Eeva in IVF Treatment

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Other Outcomes (2)

Study Arms (1)

In-vitro fertilization using Eeva

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (12)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Other Outcomes (2)

Study Arms (1)

In-vitro fertilization using Eeva

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (12)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations