Eeva System Imaging Study

Infertility Clinical Trial

— PROSPECT  

Official title:

Prospective Observational Study Utilizing the Eeva™ System 2.2.1 for Ongoing Collection of Development and Validation Data

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02301637
• Other study ID #: 2014-AUX-012
• Status: Active, not recruiting
• Phase: N/A
• First received: November 18, 2014
• Last updated: July 9, 2015
• Start date: October 2014
• Est. completion date: December 2015

Study information

• Verified date: July 2015
• Source: Progyny, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

The purpose of this clinical trial is to collect imaging data on embryos followed to blastocyst stage (Day 5-6) for ongoing development and validation of the Eeva System.

Description:

The purpose of this clinical trial is to collect imaging data on embryos followed to blastocyst stage (Day 5-6) for ongoing development and validation of the Eeva System.

Primary Objectives Include:

To collect imaging data on embryos followed to blastocyst stage (Day 5-6)

Secondary Objectives Include:

To collect enrollment data: demographics, IVF and pregnancy history To collect Day 3, Day 5 and Day 6 embryo morphology data To collect pregnancy test and outcome data To collect pre-implantation genetic screening (PGS) data (if applicable) To collect Frozen Embryo Transfer (FET) data (if applicable)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• At least 18 years of age

• Women undergoing in vitro fertilization treatment using their own eggs

• Fresh or Frozen Blastocyst (Day 5-6) transfer

• At least 5 diploid (2PN) embryos at fertilization check

• Willing to have all 2PN embryos imaged by Eeva

• Willing to comply with study protocol and procedures

• Willing to provide written informed consent

Exclusion Criteria:

• Freeze-all due to ovarian hyperstimulation syndrome (OHSS)

• Use of donor egg / gestational carrier

• Fertilization using surgically removed sperm

• History of cancer

• Assisted Hatching (AH) on Day 3

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Infertility

Intervention

Device:
• Eeva™ Test
The Eeva System is indicated to provide adjunctive information on events occurring during the first two days of development that may predict further development to the blastocyst stage on Day 5 of development. This adjunctive information aids in the selection of embryo(s) for transfer on Day 3 when, following morphological assessment on Day 3, there are multiple embryos deemed suitable for transfer or freezing.

Locations

Country	Name	City	State
New Zealand	Fertility Associates	Wellington
United States	Texas Fertility Center	Austin	Texas
United States	Midwest Fertility Specialists	Carmel	Indiana
United States	FCI (River North)	Chicago	Illinois
United States	Houston Fertility Institute	Houston	Texas
United States	University of Iowa	Iowa City	Iowa
United States	Seattle Reproductive Medicine	Seatlle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Progyny, Inc.

Countries where clinical trial is conducted

United States,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events and device malfunctions will be reported and summarized from the point of Eeva imaging through study exit.		36 months	Yes