- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02218255
Eeva™ Pregnancy Pilot Study (PPS) (PPS)
October 19, 2015 updated by: Progyny, Inc.
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.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
240
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Recruiting
- Brigham and Women's Hospital
-
Contact:
- Catherine Racowsky, Ph.D.
- Phone Number: 617-732-5570
- Email: cracowsky@partners.org
-
Principal Investigator:
- Catherine Racowsky, Ph.D.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Day 3 eSET combined with Eeva
Traditional Morphology + Eeva™ results
|
|
Active Comparator: Day 5 eSET combined with Eeva
Traditional Morphology + Eeva™ results
|
|
No Intervention: Day 5 eSET with Traditonal Morphology
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Clinical Pregnancy
Time Frame: 7-8 weeks gestation
|
7-8 weeks gestation
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Ongoing pregnancy rate
Time Frame: 8-12 week gestation
|
8-12 week gestation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2014
Primary Completion (Anticipated)
March 1, 2016
Study Completion (Anticipated)
June 1, 2016
Study Registration Dates
First Submitted
August 14, 2014
First Submitted That Met QC Criteria
August 15, 2014
First Posted (Estimate)
August 18, 2014
Study Record Updates
Last Update Posted (Estimate)
October 20, 2015
Last Update Submitted That Met QC Criteria
October 19, 2015
Last Verified
October 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2013-AUX-010
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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