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

Completed

• Conditions: Infertility

• Registration Number: NCT01635049
• Lead Sponsor: Progyny, Inc.

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-07-02
• Study First Submitted QC: 2012-07-03
• Study First Posted: 2012-07-06
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-12
• Last Update Posted: 2015-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 110

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Eeva time-lapse parameters and CCS	5-6 days	Analyse the correlation of time-lapse parameters collected by the Eeva System and comprehensive chromosome screening (CCS) results.

Secondary Outcome Measures

Name	Time	Method
Correlation of time-lapse parameters collected by the Eeva System and implantation rate.	6 weeks
Correlation of time-lapse parameters collected by the Eeva System and clinical pregnancy rate	6 weeks
Correlation of time-lapse parameters collected by the Eeva System and ongoing pregnancy rate	7 - 8 weeks
Correlation of time-lapse parameters collected by the Eeva System and delivery rate	live birth
Correlation of time-lapse parameters collected by the Eeva System and spontaneous miscarriage rate	live birth
Correlation of time-lapse parameters collected by the Eeva System and multiple pregnancy rate	live birth

Trial Locations

Locations (2)

Reproductive Medicine Associates of New York; 🇺🇸 New York, New York, United States

Reproductive Medicine Associates of New Jersey; 🇺🇸 Morristown, New Jersey, United States