Correlating Time-Lapse Parameters With aCGH Testing in IVF Treatment (aCGH Study)

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 parameters with array - Comparative Genomic Hybridization (aCGH) results and ongoing pregnancy rates.

Detailed Description
-----------------
The present study was designed to determine if there is a correlation between the Eeva System parameters and aCGH testing results. Embryos will be selected for transfer based on aCGH 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 Eeva™ With Array-Comparative Genomic Hybridization Results and Ongoing Pregnancy Rates (aCGH Study)

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is ≤43 years of age. Women undergoing IVF treatment with planned aCGH testing using her own eggs or donor eggs. Antral Follicle Count ≥ 6 at time of cycle start Baseline (day 2-3 of cycling) FSH ≤ 15 mIU/ml Antimüllerian Hormone level ≥ 0.5 ng/mL 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. 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 Planned Day 3 Assisted Hatching

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
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 |
| --- | --- |
| IVF patients undergoing aCGH Testing<br>Women undergoing fresh IVF treatment and array-comparative genomic hybridization testing (aCGH), 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 aCGH testing results | Analysis of correlation between time-lapse parameters collected by the Eeva System and array-Comparative Genomic Hybridization (aCGH) results | 5-6 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Embryo Implantation Rate | Correlation of time-lapse parameters collected by Eeva and implantation rate | 6 weeks | 
| Clinical Pregnancy Rate | Correlation of time-lapse parameters collected by Eeva and clinical pregnancy rate | 6 weeks | 
| Ongoing pregnancy rate | Correlation of time-lapse parameters collected by Eeva and ongoing pregnancy rate | 8-12 weeks | 

 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, array-Comparative Genomic Hybridization