Clinical trial NCT01635049: Correlating Time-Lapse Parameters Detected by the Eeva™ System With Comprehensive Chromosome Screening Results
Official title: Correlating Time-Lapse Parameters Detected by the Eeva™ System With Comprehensive Chromosome Screening Results,Implantation and Live Birth
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Keywords: in vitro fertilization
assisted reproduction techniques
noninvasive imaging of embryos
time lapse imaging of embryos
traditional morphological grading of embryos
prediction of blastocysts
infertility
preimplantation genetic diagnosis
comprehensive chromosome screening
Lead sponsor: Progyny, Inc.
Sponsor class: INDUSTRY
First posted: 2012-07-06
Enrollment: 110
Sex: FEMALE
Maximum age (years): 43
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women undergoing fresh IVF treatment and undergoing CCS, as recommended based on medical need by the clinical site reproductive endocrinologist.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Eeva time-lapse parameters and CCS
timeFrame: 5-6 days
Secondary outcomes:
measure: Correlation of time-lapse parameters collected by the Eeva System and implantation rate.
timeFrame: 6 weeks
measure: Correlation of time-lapse parameters collected by the Eeva System and clinical pregnancy rate
timeFrame: 6 weeks
measure: Correlation of time-lapse parameters collected by the Eeva System and ongoing pregnancy rate
timeFrame: 7 - 8 weeks
measure: Correlation of time-lapse parameters collected by the Eeva System and delivery rate
timeFrame: live birth
measure: Correlation of time-lapse parameters collected by the Eeva System and spontaneous miscarriage rate
timeFrame: live birth
measure: Correlation of time-lapse parameters collected by the Eeva System and multiple pregnancy rate
timeFrame: live birth
Other outcomes:
Locations:
city: Morristown
country: United States
facility: Reproductive Medicine Associates of New Jersey
state: New Jersey
city: New York
country: United States
facility: Reproductive Medicine Associates of New York
state: New York
Study officials:
affiliation: Reproductive Medicine Associates of New Jersey
name: Richard T Scott, Jr., MD
role: PRINCIPAL_INVESTIGATOR
References: