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

Infertility Clinical Trial

— EPIC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01671644
• Other study ID #: 2012-AUX-005
• Secondary ID: TST-1872-p
• Status: Completed
• Phase: N/A
• First received: August 21, 2012
• Last updated: October 19, 2015
• Start date: February 2013
• Est. completion date: October 2015

Study information

• Verified date: October 2015
• Source: Progyny, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)Belgium: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: October 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Observational Model: Case Control

Related Conditions & MeSH terms

• Infertility

Locations

Country	Name	City	State
Belgium	Gent University Hospital	Gent	East Flanders
Netherlands	VU University Medical Center	Amsterdam	South Holland

Sponsors (1)

Lead Sponsor	Collaborator
Progyny, Inc.

Countries where clinical trial is conducted

Belgium,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Implantation rate (# of implanted embryos out of # of total embryos transferred)		5-8 weeks gestational age.	No
Secondary	Ongoing Pregnancy Rate (gestational week 10-12)		Gestational age week 10-12	No
Secondary	Multiple pregnancy rate		Gestational weeks 5-8 and 10-12	No
Secondary	Spontaneous miscarriage rate		Gestational age week 10-12	No