Eeva™ Pregnancy Investigational Clinical Study: A Postmarket Follow-Up Study (EPIC)
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
First received: August 21, 2012
Last updated: February 11, 2014
Last verified: February 2014
The purpose of this postmarket study is to gather data to evaluate the impact of using Eeva with traditional morphology grading on clinical pregnancy rates.
||Observational Model: Case Control
||Eeva™ Pregnancy Investigational Clinical Study: A Postmarket Follow-Up Study
Primary Outcome Measures:
Secondary Outcome Measures:
- Implantation rate (# of implanted embryos out of # of total embryos transferred) [ Time Frame: 5-8 weeks gestational age. ] [ Designated as safety issue: No ]
- Ongoing Pregnancy Rate (gestational week 10-12) [ Time Frame: Gestational age week 10-12 ] [ Designated as safety issue: No ]
- Multiple pregnancy rate [ Time Frame: Gestational weeks 5-8 and 10-12 ] [ Designated as safety issue: No ]
- Spontaneous miscarriage rate [ Time Frame: Gestational age week 10-12 ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||March 2014 (Final data collection date for primary outcome measure)
Eeva Test Group
Day 3 embryo transfers that used Eeva predictions with morphology grading.
Matched case control group
Day 3 embryo transfers using morphology grading only (from a matched concurrent control group).
The purpose of this postmarket study is to gather data to evaluate the impact of using Eeva with traditional morphology grading on clinical pregnancy rates, as compared to a matched case control group that used morphology grading only to select embryos for transfer.
|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 ≤ 3.
- Egg age ≤ 40 years.
- Planned Day 3 embryo transfer.
- At least 5 normally fertilized eggs (2PN).
- All 2PN embryos must be imaged by Eeva.
- Normal uterine cavity as evaluated by standard methods.
- Fertilization using only ejaculated sperm (fresh or frozen) - no surgically removed sperm.
- Willing to comply with study protocol and procedures.
- Willing to provide written informed consent.
- Planned preimplantation genetic diagnosis.
- Planned "freeze all" cycle (oocytes or embryos).
- Concurrent participation in another clinical study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01671644
|Gent University Hospital
|Gent, East Flanders, Belgium, 9000 Gent |
|VU University Medical Center
|Amsterdam, South Holland, Netherlands, 2500 BH |
||Shehua Shen, MD, ELD
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 21, 2012
||February 11, 2014
||Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Belgium: Ethics Committee
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 April 17, 2014
Genital Diseases, Male
Genital Diseases, Female