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

Study Overview
=================
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.

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

Conditions
-----------------
Infertility

Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Maximum Age: 43 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Women undergoing IVF treatment and CCS<br>•Women undergoing fresh IVF treatment and undergoing CCS, as recommended based on medical need by the clinical site reproductive endocrinologist. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
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