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Eeva™ Pregnancy Pilot Study (PPS) (PPS)

Primary Purpose

Infertility

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Eeva™ results
Sponsored by
Progyny, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring In Vitro Fertilization

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Brigham and Women's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

Day 3 eSET combined with Eeva

Day 5 eSET combined with Eeva

Day 5 eSET with Traditonal Morphology

Arm Description

Traditional Morphology + Eeva™ results

Traditional Morphology + Eeva™ results

Outcomes

Primary Outcome Measures

Clinical Pregnancy

Secondary Outcome Measures

Ongoing pregnancy rate

Full Information

First Posted
August 14, 2014
Last Updated
October 19, 2015
Sponsor
Progyny, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02218255
Brief Title
Eeva™ Pregnancy Pilot Study (PPS)
Acronym
PPS
Official Title
Eeva™ Pregnancy Pilot Study (PPS)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Unknown status
Study Start Date
August 2014 (undefined)
Primary Completion Date
March 2016 (Anticipated)
Study Completion Date
June 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Progyny, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
In Vitro Fertilization

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Day 3 eSET combined with Eeva
Arm Type
Active Comparator
Arm Description
Traditional Morphology + Eeva™ results
Arm Title
Day 5 eSET combined with Eeva
Arm Type
Active Comparator
Arm Description
Traditional Morphology + Eeva™ results
Arm Title
Day 5 eSET with Traditonal Morphology
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Eeva™ results
Primary Outcome Measure Information:
Title
Clinical Pregnancy
Time Frame
7-8 weeks gestation
Secondary Outcome Measure Information:
Title
Ongoing pregnancy rate
Time Frame
8-12 week gestation

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Monica Ransom
Phone
650-627-7604
Email
mransom@auxogyn.com
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catherine Racowsky, Ph.D.
Phone
617-732-5570
Email
cracowsky@partners.org
First Name & Middle Initial & Last Name & Degree
Catherine Racowsky, Ph.D.

12. IPD Sharing Statement

Citations:
PubMed Identifier
28854588
Citation
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.
Results Reference
derived

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Eeva™ Pregnancy Pilot Study (PPS)

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