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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02301637




Registration number
NCT02301637
Ethics application status
Date submitted
18/11/2014
Date registered
26/11/2014
Date last updated
13/07/2015

Titles & IDs
Public title
Eeva System Imaging Study
Scientific title
Prospective Observational Study Utilizing the Eeva™ System 2.2.1 for Ongoing Collection of Development and Validation Data
Secondary ID [1] 0 0
2014-AUX-012
Universal Trial Number (UTN)
Trial acronym
PROSPECT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infertility 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - Eeva™ Test

Treatment: Devices: 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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Adverse events and device malfunctions will be reported and summarized from the point of Eeva imaging through study exit.
Timepoint [1] 0 0
36 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key 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
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2015
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Illinois
Country [2] 0 0
United States of America
State/province [2] 0 0
Indiana
Country [3] 0 0
United States of America
State/province [3] 0 0
Iowa
Country [4] 0 0
United States of America
State/province [4] 0 0
Texas
Country [5] 0 0
United States of America
State/province [5] 0 0
Washington
Country [6] 0 0
New Zealand
State/province [6] 0 0
Wellington

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Progyny, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02301637
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sheua Shen, MD
Address 0 0
Vice President, Scientific and Medical Affairs
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02301637