TiLE (Time Lapse Eeva) Clinical Trial

Study Overview
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Brief Summary
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The purpose of the study was to explore the added value of adjunctive use of Early Embryo Viability Assessment (Eeva) with morphological grading in identifying optimal embryos for transfer.

Detailed Description
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This study is a Phase IV, open label, prospective, randomized, exploratory, multicenter study. Subjects were randomized in 2:1 ratio to two treatment groups: in the experimental group, embryos were assessed for embryo transfer (ET) with Eeva and morphological grading, while in the control group embryos were assessed with morphological grading only.

Official Title
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A Phase IV, Prospective, Randomized, Exploratory, Multicenter, Eeva™ Trial (Time Lapse Eeva - TiLE)

Conditions
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Fertility

Intervention / Treatment
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* Device: Eeva


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All infertile subjects treated with In vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI) Subject age less than or equal to (<=) 40 years Less than or equal to (<=) 3 failed IVF/ICSI cycles At least 4 normally fertilized eggs (2 pronuclei [2PN]) in current cycle Normal uterine cavity Fertilization using only ejaculated sperm (fresh or frozen) Subject must have read and signed the Informed Consent Form Exclusion Criteria: Have clinically significant systemic disease Have abnormal, undiagnosed gynecological bleeding Have any contraindication to Controlled Ovarian Stimulation (COS) for assisted reproductive technologies (ART) and to gonadotropins to be used in ART Egg donor cycle Planned freeze all cycle (oocytes or embryos) Concurrent participation in another clinical trial

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early Embryo Viability Assessment + Morphological Grading<br>Embryos of subjects randomized in this group were assessed using Early Embryo Viability Assessment (Eeva) System and morphological grading to identify optimal embryos for transfer. | Device: Eeva<br>* Embryos of subjects randomized in this group were assessed using Eeva System and morphological grading to identify optimal embryos for transfer.<br>|
| No Intervention: Morphological Grading<br>Embryos of subjects randomized in this group were assessed only using morphological grading to identify optimal embryos for transfer. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implantation Rate | Implantation rate was calculated by dividing the number of intrauterine gestational sacs by the number of embryos transferred multiplied by 100. | Gestational Weeks 5 to 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Pregnancy Rate | Clinical pregnancy was confirmed by the presence of a gestational sac with heartbeat as assessed by ultrasonography. Clinical pregnancy rate was measured as the number of clinical pregnancies divided by number of embryo transfer (ET) cycles multiplied by 100. | Gestational Weeks 5 to 8 | 
| Number of Subjects With Ongoing Pregnancy Status | Ongoing pregnancy was defined as having a positive fetal heart beat (FHB) as assessed by ultrasonography at gestational week 10-12. Number of subjects with ongoing pregnancy status has been reported, where Yes indicates participants with positive ongoing pregnancy status and No indicates participants with negative ongoing pregnancy status . | Gestational Weeks 10 to 12 | 
| Multiple Pregnancy Rate | Multiple pregnancy rate was defined as a clinical pregnancy with greater than equals to (>=) 2 fetal sacs as assessed by ultrasonography. Multiple Pregnancies rate was measured by number of multiple pregnancies divided by number of embryo transfer cycles multiplied by 100. | Gestational Weeks 5 to 8 | 
| Utilization Rate | Utilization rate was defined as the sum of number of transferred and frozen embryos divided by number of normally fertilized oocytes multiplied by 100. | Day 3 or Day 5/6 of embryo culture | 
| Spontaneous Miscarriage Rate | Spontaneous miscarriage rate was measured by the number of spontaneous miscarriages as communicated during medical appointment or by telephone contact divided by number of clinical pregnancies multiplied by 100. | Gestational Weeks 10 to 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TiLE, Embryo Assessment, Pregnancy, Implantation