US Eeva™ Pregnancy Investigational Clinical Study (US EPIC)
US EPIC
1 other identifier
observational
100
1 country
1
Brief Summary
The purpose of this clinical investigation is to gather data to evaluate the impact of using Eeva with traditional morphology grading on implantation rates.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2013
Typical duration for all trials
1 active site
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
First Submitted
Initial submission to the registry
August 21, 2012
CompletedFirst Posted
Study publicly available on registry
August 23, 2012
CompletedStudy Start
First participant enrolled
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedOctober 20, 2015
October 1, 2015
3.4 years
August 21, 2012
October 19, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of implantation
To compare implantation rates for the Day 3 embryo transfers that used Eeva with morphology grading (test group) versus Day 3 embryo transfers using morphology grading only (control group).
5-6 gestational age
Secondary Outcomes (4)
To evaluate clinical pregnancy rates from the Eeva Test group to the Control group
5-6 weeks gestational age
Ongoing pregnancy rate
Gestational age week 8-12
Multiple pregnancy rate
Gestational age weeks 5-6 and 8-12
Spontaneous miscarriage rate
Gestational age week 8-12
Study Arms (2)
Eeva Test Group
Day 3 embryo transfers that used Eeva with morphology grading (Test Group).
Matched case control group
Day 3 embryo transfers using morphology grading only (from concurrent Control Group).
Eligibility Criteria
Patients undergoing in vitro fertilization treatment who provide informed consent and plan to undergo Day 3 embryo transfer.
You may qualify if:
- Women undergoing fresh in vitro fertilization treatment using their own eggs or donor eggs.
- IVF cycle attempts ≤ 2.
- Egg age ≤ 40 years.
- Planned Day 3 embryo transfer.
- At least 4 normally fertilized eggs (2PN).
- All 2PN embryos must be imaged by Eeva.
- Ejaculated sperm or sperm from the epididymis (fresh or frozen).
- Willing to comply with study protocol and procedures.
- Willing to provide written informed consent.
You may not qualify if:
- Planned preimplantation genetic diagnosis or preimplantation genetic screening.
- Planned "freeze all" cycle (oocytes or embryos).
- Sperm retrieved from testicular tissue.
- Abnormal uterine cavity as evaluated by standard methods.
- Gestational carrier.
- Endometriosis
- Hydrosalpinx.
- History of cancer.
- Concurrent participation in another clinical study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Progyny, Inc.lead
Study Sites (1)
Fertility Physicians of Northern California
San Jose, California, 95124, United States
Related Publications (1)
Adamson GD, Abusief ME, Palao L, Witmer J, Palao LM, Gvakharia M. Improved implantation rates of day 3 embryo transfers with the use of an automated time-lapse-enabled test to aid in embryo selection. Fertil Steril. 2016 Feb;105(2):369-75.e6. doi: 10.1016/j.fertnstert.2015.10.030. Epub 2015 Nov 18.
PMID: 26604069DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Shehua Shen, MD, ELD
Progyny, Inc.
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 21, 2012
First Posted
August 23, 2012
Study Start
January 1, 2013
Primary Completion
June 1, 2016
Study Completion
June 1, 2016
Last Updated
October 20, 2015
Record last verified: 2015-10