Recruiting

Eeva™

Sponsor:

Progyny, Inc.

Code:

NCT02218255

Conditions

Infertility

Eligibility Criteria

Sex: Female

Age: 18 - 40

Healthy Volunteers: Not accepted

Interventions

Eeva™ results

Study Details

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.

Conditions

Infertility

Study ID

NCT02218255

Start date

Aug, 2014

Status verified date

Oct, 2015

Completion date

Jun, 2016

Anticipated

Primary completion date

Mar, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 40

Healthy Volunteers: Not accepted

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

Enrollment

240 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

Interventions

Eeva™ results

Primary outcome measure

  • Clinical Pregnancy [ Time Frame: 7-8 weeks gestation ]

Central Contacts and Locations

Central contacts

Monica Ransom

650-627-7604mransom@auxogyn.com

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Catherine Racowsky, Ph.D.

617-732-5570cracowsky@partners.org

Principal Investigator:

Catherine Racowsky, Ph.D.

More Information

Sponsor

Progyny, Inc.

Last update posted

Oct 20, 2015

Last verified

Oct, 2015

Keywords

  • In Vitro Fertilization

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Progyny, Inc. on 2015-10-20.