US Eeva™ Pregnancy Investigational Clinical Study (US EPIC)

NCT ID: NCT01671657

Last Updated: 2015-10-20

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-31

Study Completion Date

2016-06-30

Brief Summary

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The purpose of this clinical investigation is to gather data to evaluate the impact of using Eeva with traditional morphology grading on implantation rates.

Detailed Description

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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).

Conditions

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Infertility

Study Design

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Observational Model Type

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

* 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.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Progyny, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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United States

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.

Reference Type DERIVED
PMID: 26604069 (View on PubMed)

Other Identifiers

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2012-AUX-008

Identifier Type: -

Identifier Source: org_study_id

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