Eeva™ Pregnancy Pilot Study (PPS)

NCT ID: NCT02218255

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

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2016-06-30

Brief Summary

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The purpose of this clinical investigation is to gather pilot data to evaluate the impact of using Eeva™, a time-lapse enabled embryo test, in combination with traditional morphology on clinical pregnancy rates.

Detailed Description

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Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Day 3 eSET combined with Eeva

Traditional Morphology + Eeva™ results

Group Type ACTIVE_COMPARATOR

Eeva™ results

Intervention Type DEVICE

Day 5 eSET combined with Eeva

Traditional Morphology + Eeva™ results

Group Type ACTIVE_COMPARATOR

Eeva™ results

Intervention Type DEVICE

Day 5 eSET with Traditonal Morphology

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Eeva™ results

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Women undergoing fresh in vitro fertilization treatment using their own eggs
* ≤ 40 years
* ≥ 4 diploid embryos (i.e. having 2 PNs)
* ≤ 3 Prior ART cycles (IVF, ICSI and related procedures)
* All 2PN embryos (for all 3 arms) must be imaged by Eeva
* Subject willing to comply with study protocol and procedures
* Subject willing to provide written informed consent

Exclusion Criteria

* Preimplantation genetic diagnosis or preimplantation genetic screening
* Planned "freeze all" cycle (eggs or embryos)
* Asherman's Syndrome
* Donor egg
* Gestational carrier
* Presence of Hydrosalpinx on ultrasound
* Concurrent participation in an interventional clinical study
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

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

Locations

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Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Monica Ransom

Role: CONTACT

650-627-7604

Facility Contacts

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Catherine Racowsky, Ph.D.

Role: primary

617-732-5570

References

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Kaser DJ, Bormann CL, Missmer SA, Farland LV, Ginsburg ES, Racowsky C. A pilot randomized controlled trial of Day 3 single embryo transfer with adjunctive time-lapse selection versus Day 5 single embryo transfer with or without adjunctive time-lapse selection. Hum Reprod. 2017 Aug 1;32(8):1598-1603. doi: 10.1093/humrep/dex231.

Reference Type DERIVED
PMID: 28854588 (View on PubMed)

Other Identifiers

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2013-AUX-010

Identifier Type: -

Identifier Source: org_study_id

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