US Eeva™ Pregnancy Investigational Clinical Study (US EPIC)
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Women's Studies, Infertility |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/21/2016 |
| Start Date: | January 2013 |
| End Date: | June 2016 |
The purpose of this clinical investigation is to gather data to evaluate the impact of using
Eeva with traditional morphology grading on implantation rates.
Eeva with traditional morphology grading on implantation rates.
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).
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).
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
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