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

Completed

Conditions studied: Infertility

In brief

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.

Key facts

Study ID

NCT01635049

Run by

Progyny, Inc.

People needed

110

Starts

2012-06-01

Expected to finish

2014-12-01

Last updated by the study team

2015-01-14

Who can join

Age: any, up to 43. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Reproductive Medicine Associates of New Jersey — Morristown, New Jersey, United States
• Reproductive Medicine Associates of New York — New York, New York, United States

Full record on ClinicalTrials.gov

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