Eeva™ Pregnancy Pilot Study (PPS)
PPS
1 other identifier
interventional
240
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2014
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2014
CompletedFirst Submitted
Initial submission to the registry
August 14, 2014
CompletedFirst Posted
Study publicly available on registry
August 18, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedOctober 20, 2015
October 1, 2015
1.6 years
August 14, 2014
October 19, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical Pregnancy
7-8 weeks gestation
Secondary Outcomes (1)
Ongoing pregnancy rate
8-12 week gestation
Study Arms (3)
Day 3 eSET combined with Eeva
ACTIVE COMPARATORTraditional Morphology + Eeva™ results
Day 5 eSET combined with Eeva
ACTIVE COMPARATORTraditional Morphology + Eeva™ results
Day 5 eSET with Traditonal Morphology
NO INTERVENTIONInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Progyny, Inc.lead
Study Sites (1)
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Related Publications (1)
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.
PMID: 28854588DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 14, 2014
First Posted
August 18, 2014
Study Start
August 1, 2014
Primary Completion
March 1, 2016
Study Completion
June 1, 2016
Last Updated
October 20, 2015
Record last verified: 2015-10