Eeva™ Pregnancy Investigational Clinical Study: A Postmarket Follow-Up Study

Study Overview
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Brief Summary
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The purpose of this postmarket study is to gather data to evaluate the impact of using Eeva with traditional morphology grading on clinical pregnancy rates.

Detailed Description
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The purpose of this postmarket study is to gather data to evaluate the impact of using Eeva with traditional morphology grading on clinical pregnancy rates, as compared to a matched case control group that used morphology grading only to select embryos for transfer.

Official Title
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Eeva™ Pregnancy Investigational Clinical Study: A Postmarket Follow-Up Study

Conditions
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Infertility

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women undergoing fresh in vitro fertilization treatment using their own eggs or donor eggs. IVF cycle attempts ≤ 3. Egg age ≤ 40 years. Planned Day 3 embryo transfer. At least 5 normally fertilized eggs (2PN). All 2PN embryos must be imaged by Eeva. Normal uterine cavity as evaluated by standard methods. Fertilization using only ejaculated sperm (fresh or frozen) - no surgically removed sperm. Willing to comply with study protocol and procedures. Willing to provide written informed consent. Exclusion Criteria: Planned preimplantation genetic diagnosis. Planned freeze all cycle (oocytes or embryos). Concurrent participation in another clinical study.
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Eeva Test Group<br>Day 3 embryo transfers that used Eeva predictions with morphology grading. | |
| Matched case control group<br>Day 3 embryo transfers using morphology grading only (from a matched concurrent control group). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of clinical pregnancy | To compare the rate of clinical pregnancy at approximately 5-8 weeks gestational age for the Day 3 embryo transfers that used Eeva predictions with morphology grading to that for Day 3 embryo transfers using morphology grading only (from a matched concurrent control group at each clinical site comprised of year 2011-2013 patients). | 5-8 weeks gestational age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implantation rate (# of implanted embryos out of # of total embryos transferred) |  | 5-8 weeks gestational age. | 
| Ongoing Pregnancy Rate (gestational week 10-12) |  | Gestational age week 10-12 | 
| Multiple pregnancy rate |  | Gestational weeks 5-8 and 10-12 | 
| Spontaneous miscarriage rate |  | Gestational age week 10-12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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In vitro fertilization, Assisted reproductive therapy, Time-lapse image recording, Image analysis software