Eeva™ Pregnancy Pilot Study (PPS)

Not Applicable

• Conditions: Infertility

• Registration Number: NCT02218255
• Lead Sponsor: Progyny, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-08-14
• Study First Submitted QC: 2014-08-15
• Study First Posted: 2014-08-18
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-19
• Last Update Posted: 2015-10-20
• Primary Completion: 2016-03
• Study Completion: 2016-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 240

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Clinical Pregnancy	7-8 weeks gestation

Secondary Outcome Measures

Name	Time	Method
Ongoing pregnancy rate	8-12 week gestation

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States