Registry Study of Traditional Morphology Grading Combined With Eeva in IVF Treatment

• Conditions: Infertility
• Interventions: Device: In-vitro fertilization using Eeva

• Registration Number: NCT01816802
• Lead Sponsor: Progyny, Inc.

Brief Summary

The purpose of this study is to record and evaluate the use of traditional morphology grading combined with Eeva in the treatment of in vitro fertilization.

Detailed Description

This is a prospective, observational, single-arm, nonrandomized, multicenter study. Data will be collected to establish eligibility, at baseline, during the stimulation and in vitro fertilization process, during embryo culture, at embryo transfer, at 12-18 days post egg retrieval to verify biochemical pregnancy, and then typically at 5-6 weeks gestational weeks to verify clinical pregnancy.

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-03-20
• Study First Submitted QC: 2013-03-20
• Study First Posted: 2013-03-22
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-25
• Last Update Posted: 2015-03-26
• Primary Completion: 2015-06
• Study Completion: 2015-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 1200

Inclusion Criteria

• women undergoing fresh in vitro fertilization treatment using their own eggs or donor eggs.

Exclusion Criteria

• history of cancer.
• gestational carrier.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
In-vitro fertilization using Eeva	In-vitro fertilization using Eeva	Patients undergoing in-vitro fertilization treatment who provide informed consent and use Eeva in their treatment cycle.

Primary Outcome Measures

Name	Time	Method
Clinical Pregnancy Rate	5-6 gestational weeks	Determined by first pregnancy ultrasound outcome and optional 12-month phone follow-up

Trial Locations

Locations (12)

HRC Fertility; 🇺🇸 Encino, California, United States

Stanford Fertility and Reproductive Medicine Center; 🇺🇸 Palo Alto, California, United States

Fertility Centers of Illinois - River North; 🇺🇸 Chicago, Illinois, United States

Fertility Centers of Illinois, Highland Park IVF Center; 🇺🇸 Highland Park, Illinois, United States

Institute for Reproductive Health; 🇺🇸 Cincinnati, Ohio, United States

Fertility Center of San Antonio; 🇺🇸 San Antonio, Texas, United States

Northwestern Medical Faculty Foundation; 🇺🇸 Chicago, Illinois, United States

Long Island IVF; 🇺🇸 Melville, New York, United States

University Hospital Fertility Center; 🇺🇸 Beachwood, Ohio, United States

Reproductive Partners; 🇺🇸 Redondo Beach, California, United States

Pacific Fertility Center; 🇺🇸 San Francisco, California, United States

Center for Advanced Reproductive Services (UCHC); 🇺🇸 Farmington, Connecticut, United States