US Eeva™ Pregnancy Investigational Clinical Study (US EPIC)
This study is currently recruiting participants.
Verified March 2013 by Auxogyn, Inc.
Information provided by (Responsible Party):
First received: August 21, 2012
Last updated: March 18, 2013
Last verified: March 2013
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:
||January 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).
|Ages Eligible for Study:
||18 Years to 40 Years
|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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01671657
||Shehua Shen, MD, ELD
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 21, 2012
||March 18, 2013
||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 June 18, 2013
Genital Diseases, Male
Genital Diseases, Female