US Eeva™ Pregnancy Investigational Clinical Study (US EPIC)
Verified June 2014 by Auxogyn, Inc.
Information provided by (Responsible Party):
First received: August 21, 2012
Last updated: June 11, 2014
Last verified: June 2014
The purpose of this clinical investigation is to gather data to evaluate the impact of using Eeva with traditional morphology grading on implantation rates.
||Observational Model: Case Control
||US Eeva™ Pregnancy Investigational Clinical Study (US EPIC)
Primary Outcome Measures:
Secondary Outcome Measures:
- To evaluate clinical pregnancy rates from the Eeva Test group to the Control group [ Time Frame: 5-6 weeks gestational age ] [ Designated as safety issue: No ]
- Ongoing pregnancy rate [ Time Frame: Gestational age week 8-12 ] [ Designated as safety issue: No ]
- Multiple pregnancy rate [ Time Frame: Gestational age weeks 5-6 and 8-12 ] [ Designated as safety issue: No ]
- Spontaneous miscarriage rate [ Time Frame: Gestational age week 8-12 ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2014 (Final data collection date for primary outcome measure)
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).
The purpose of this clinical investigation is to gather data to evaluate the impact of implantation rates for Day 3 embryo transfers using Eeva and morphology grading (test group) versus Day 3 embryo transfers using morphology grading only (from a concurrent control group).
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Patients undergoing in vitro fertilization treatment who provide informed consent and plan to undergo Day 3 embryo transfer.
- 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.
- 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.
- History of cancer.
- Concurrent participation in another clinical study.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01671657
||Shehua Shen, MD, ELD
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 21, 2012
||June 11, 2014
||United States: Institutional Review Board
Keywords provided by Auxogyn, Inc.:
In vitro fertilization
Assisted reproductive therapy
Time-lapse image recording
Image analysis software
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 29, 2014
Genital Diseases, Male
Genital Diseases, Female