Eeva™ Pregnancy Investigational Clinical Study: A Postmarket Follow-Up Study

NCT01671644 | Completed

• 2 other identifiers: 2012-AUX-005TST-1872-p
• Study Type: observational
• Target: 104
• Locations: 2 countries
• Sites: 2

Brief Summary

The purpose of this postmarket study is to gather data to evaluate the impact of using Eeva with traditional morphology grading on clinical pregnancy rates.

Conditions

Infertility

Keywords

In vitro fertilization; Assisted reproductive therapy; Time-lapse image recording; Image analysis software

Outcome Measures

Primary Outcomes (1)

• Rate of clinical pregnancy

  To compare the rate of clinical pregnancy at approximately 5-8 weeks gestational age for the Day 3 embryo transfers that used Eeva predictions with morphology grading to that for Day 3 embryo transfers using morphology grading only (from a matched concurrent control group at each clinical site comprised of year 2011-2013 patients).

  5-8 weeks gestational age

Secondary Outcomes (4)

• Implantation rate (# of implanted embryos out of # of total embryos transferred)

  5-8 weeks gestational age.

• Ongoing Pregnancy Rate (gestational week 10-12)

  Gestational age week 10-12

• Multiple pregnancy rate

  Gestational weeks 5-8 and 10-12

• Spontaneous miscarriage rate

  Gestational age week 10-12

Study Arms (2)

Eeva Test Group

Day 3 embryo transfers that used Eeva predictions with morphology grading.

Matched case control group

Day 3 embryo transfers using morphology grading only (from a matched concurrent control group).

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing in vitro fertilization treatment who provide informed consent and plan to undergo Day 3 embryo transfer.

You may qualify if:

• Women undergoing fresh in vitro fertilization treatment using their own eggs or donor eggs.
• IVF cycle attempts ≤ 3.
• Egg age ≤ 40 years.
• Planned Day 3 embryo transfer.
• At least 5 normally fertilized eggs (2PN).
• All 2PN embryos must be imaged by Eeva.
• Normal uterine cavity as evaluated by standard methods.
• Fertilization using only ejaculated sperm (fresh or frozen) - no surgically removed sperm.
• Willing to comply with study protocol and procedures.
• Willing to provide written informed consent.

You may not qualify if:

• Planned preimplantation genetic diagnosis.
• Planned "freeze all" cycle (oocytes or embryos).
• Concurrent participation in another clinical study.

Sponsors & Collaborators

• Progyny, Inc.: lead

Study Sites (2)

Gent University Hospital

Ghent, East Flanders, 9000 Gent, Belgium

Location

VU University Medical Center

Amsterdam, South Holland, 2500 BH, Netherlands

Location

Related Publications (1)

• Kieslinger DC, De Gheselle S, Lambalk CB, De Sutter P, Kostelijk EH, Twisk JW, van Rijswijk J, Van den Abbeel E, Vergouw CG. Embryo selection using time-lapse analysis (Early Embryo Viability Assessment) in conjunction with standard morphology: a prospective two-center pilot study. Hum Reprod. 2016 Nov;31(11):2450-2457. doi: 10.1093/humrep/dew207. Epub 2016 Sep 12.

  PMID: 27619774 DERIVED

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Shehua Shen, MD, ELD

  Progyny, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2012
• First Posted: August 23, 2012
• Study Start: February 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: October 1, 2015
• Last Updated: October 20, 2015

Record last verified: 2015-10

Locations

BE (1); NL (1)