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

Infertility Clinical Trial

— MERGE  

Official title:

MERGE: MulticEnter ReGistry With Eeva

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01816802
• Other study ID #: 2012-AUX-009
• Secondary ID: TST 2193-p
• Status: Active, not recruiting
• Phase: N/A
• First received: March 20, 2013
• Last updated: March 25, 2015
• Start date: February 2013
• Est. completion date: June 2015

Study information

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

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1200
• Est. completion date: June 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.

Exclusion Criteria:

• history of cancer.

• gestational carrier.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Infertility

Intervention

Device:
• In-vitro fertilization using Eeva
Eeva will image embryos through cleavage stage (Day 3). Embryologists will use Eeva results along with traditional morphological grading to assist in selecting embryo(s) for transfer or freezing.

Locations

Country	Name	City	State
United States	University Hospital Fertility Center	Beachwood	Ohio
United States	Fertility Centers of Illinois - River North	Chicago	Illinois
United States	Northwestern Medical Faculty Foundation	Chicago	Illinois
United States	Institute for Reproductive Health	Cincinnati	Ohio
United States	HRC Fertility	Encino	California
United States	Center for Advanced Reproductive Services (UCHC)	Farmington	Connecticut
United States	Fertility Centers of Illinois, Highland Park IVF Center	Highland Park	Illinois
United States	Long Island IVF	Melville	New York
United States	Stanford Fertility and Reproductive Medicine Center	Palo Alto	California
United States	Reproductive Partners	Redondo Beach	California
United States	Fertility Center of San Antonio	San Antonio	Texas
United States	Pacific Fertility Center	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Progyny, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Multiple Pregnancy Rate	Determined by follow-up pregnancy ultrasound outcome	5-6 gestational weeks	No
Other	Spontaneous Miscarriage Rate	Determined by follow-up pregnancy ultrasound outcome	5-6 gestational weeks	No
Primary	Clinical Pregnancy Rate	Determined by first pregnancy ultrasound outcome and optional 12-month phone follow-up	5-6 gestational weeks	No

External Links

•   Auxogyn, Inc. website