US Eeva™ Pregnancy Investigational Clinical Study (US EPIC)
NCT ID: NCT01671657
Last Updated: 2015-10-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
100 participants
OBSERVATIONAL
2013-01-31
2016-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
Study Groups
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Eeva Test Group
Day 3 embryo transfers that used Eeva with morphology grading (Test Group).
No interventions assigned to this group
Matched case control group
Day 3 embryo transfers using morphology grading only (from concurrent Control Group).
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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 "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.
FEMALE
No
Sponsors
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Progyny, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Shehua Shen, MD, ELD
Role: STUDY_DIRECTOR
Progyny, Inc.
Locations
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Fertility Physicians of Northern California
San Jose, California, United States
Countries
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References
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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.
Other Identifiers
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2012-AUX-008
Identifier Type: -
Identifier Source: org_study_id
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