US Eeva™ Pregnancy Investigational Clinical Study (US EPIC)

Infertility Clinical Trial

— US EPIC  

Official title:

US Eeva™ Pregnancy Investigational Clinical Study (US EPIC)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01671657
• Other study ID #: 2012-AUX-008
• Status: Active, not recruiting
• Phase: N/A
• First received: August 21, 2012
• Last updated: October 19, 2015
• Start date: January 2013
• Est. completion date: June 2016

Study information

• Verified date: October 2015
• Source: Progyny, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

Description:

The purpose of this clinical investigation is to gather data to evaluate the impact of implantation rates for Day 3 embryo transfers using Eeva and morphology grading (test group) versus Day 3 embryo transfers using morphology grading only (from a concurrent control group).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• 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 = 2.

• Egg age = 40 years.

• Planned Day 3 embryo transfer.

• At least 4 normally fertilized eggs (2PN).

• All 2PN embryos must be imaged by Eeva.

• Ejaculated sperm or sperm from the epididymis (fresh or frozen).

• Willing to comply with study protocol and procedures.

• Willing to provide written informed consent.

Exclusion Criteria:

• Planned preimplantation genetic diagnosis or preimplantation genetic screening.

• Planned "freeze all" cycle (oocytes or embryos).

• Sperm retrieved from testicular tissue.

• Abnormal uterine cavity as evaluated by standard methods.

• Gestational carrier.

• Endometriosis

• Hydrosalpinx.

• History of cancer.

• Concurrent participation in another clinical study.

Study Design

Observational Model: Case Control

Related Conditions & MeSH terms

• Infertility

Locations

Country	Name	City	State
United States	Fertility Physicians of Northern California	San Jose	California

Sponsors (1)

Lead Sponsor	Collaborator
Progyny, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of implantation	To compare implantation rates for the Day 3 embryo transfers that used Eeva with morphology grading (test group) versus Day 3 embryo transfers using morphology grading only (control group).	5-6 gestational age	No
Secondary	To evaluate clinical pregnancy rates from the Eeva Test group to the Control group		5-6 weeks gestational age	No
Secondary	Ongoing pregnancy rate		Gestational age week 8-12	No
Secondary	Multiple pregnancy rate		Gestational age weeks 5-6 and 8-12	No
Secondary	Spontaneous miscarriage rate		Gestational age week 8-12	No