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

Completed

• Conditions: Infertility

• Registration Number: NCT01671644
• Lead Sponsor: Progyny, Inc.

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.

Detailed Description

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, as compared to a matched case control group that used morphology grading only to select embryos for transfer.

Study Timeline

• Study First Submitted: 2012-08-21
• Study First Submitted QC: 2012-08-22
• Study First Posted: 2012-08-23
• Study Start: 2013-02
• Primary Completion: 2015-06
• Status Verified: 2015-10
• Study Completion: 2015-10
• Last Update Submitted: 2015-10-19
• Last Update Posted: 2015-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 104

Inclusion Criteria

• 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.

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of clinical pregnancy	5-8 weeks gestational age	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).

Secondary Outcome Measures

Name	Time	Method
Ongoing Pregnancy Rate (gestational week 10-12)	Gestational age week 10-12
Multiple pregnancy rate	Gestational weeks 5-8 and 10-12
Implantation rate (# of implanted embryos out of # of total embryos transferred)	5-8 weeks gestational age.
Spontaneous miscarriage rate	Gestational age week 10-12

Trial Locations

Locations (2)

Gent University Hospital; 🇧🇪 Gent, East Flanders, Belgium

VU University Medical Center; 🇳🇱 Amsterdam, South Holland, Netherlands