Correlating Time-Lapse Parameters Detected by the Eeva™ System With Comprehensive Chromosome Screening Results

Infertility Clinical Trial

— CCS  

Official title:

Correlating Time-Lapse Parameters Detected by the Eeva™ System With Comprehensive Chromosome Screening Results,Implantation and Live Birth

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01635049
• Other study ID #: 2012-AUX-004
• Status: Completed
• Phase: N/A
• First received: July 2, 2012
• Last updated: January 12, 2015
• Start date: June 2012
• Est. completion date: December 2014

Study information

• Verified date: January 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 research study protocol is to collect imaging data on embryos followed to blastocyst stage (Day 5-6) and correlate Eeva System parameters with comprehensive chromosome screening (CCS) results, implantation and live birth.

Description:

The present study was designed to determine if there is a correlation between the Eeva System parameters and CCS results. Embryos will be selected for transfer based on CCS results and morphology. The Clinical site will have no access to the Eeva analysis at the time of the transfer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 43 Years

Eligibility

Inclusion Criteria:

• Subject is =43 years of age.

• Women undergoing fresh IVF treatment using her own eggs or donor eggs and undergoing CCS, as recommended based on medical need by the clinical site reproductive endocrinologist.

• Fertilization using only ejaculated sperm (fresh or frozen) - no surgically retrieved sperm.

• Willing to have all 2PN embryos monitored by Eeva

• Not previously enrolled in this study.

• No concurrent participation in another clinical study.

• Willing to comply with study protocol and procedures and able to speak English.

• Willing to provide written informed consent.

Exclusion Criteria:

• BMI = 40

• Prior IVF cycle with < 4 x 2PN

• Diminished ovarian reserve as demonstrated by any one of the following:

• BAFC < 6 at time of cycle start

• Maximum prior FSH > 15

• AMH < 0.5

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Infertility

Locations

Country	Name	City	State
United States	Reproductive Medicine Associates of New Jersey	Morristown	New Jersey
United States	Reproductive Medicine Associates of New York	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Progyny, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Eeva time-lapse parameters and CCS	Analyse the correlation of time-lapse parameters collected by the Eeva System and comprehensive chromosome screening (CCS) results.	5-6 days	No
Secondary	Correlation of time-lapse parameters collected by the Eeva System and implantation rate.		6 weeks	No
Secondary	Correlation of time-lapse parameters collected by the Eeva System and clinical pregnancy rate		6 weeks	No
Secondary	Correlation of time-lapse parameters collected by the Eeva System and ongoing pregnancy rate		7 - 8 weeks	No
Secondary	Correlation of time-lapse parameters collected by the Eeva System and delivery rate		live birth	No
Secondary	Correlation of time-lapse parameters collected by the Eeva System and spontaneous miscarriage rate		live birth	No
Secondary	Correlation of time-lapse parameters collected by the Eeva System and multiple pregnancy rate		live birth	No

External Links

•   Auxogyn, Inc. website