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

Progyny

Status: Completed

Conditions: Infertility

Study type: Observational

Funder types: Industry

Identifiers

NCT01635049

2012-AUX-004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 patients

Sex: Female

Ages: Under 43 years old

Volunteers: No Healthy Volunteers

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

Trial design

110 participants in 1 patient group

Women undergoing IVF treatment and CCS

Description:

•Women undergoing fresh IVF treatment and undergoing CCS, as recommended based on medical need by the clinical site reproductive endocrinologist.