Randomized Trial Comparing EmbryoScope With EmbryoScope+.

Study Overview
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Brief Summary
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The purpose of the study is to compare the current EmbryoScope Time-Lapse System being used in IVF which has become standard of care to the new model EmbryoScope to demonstrate that the EmbryoScope+ is as safe and reliable as the EmbryoScope.

Detailed Description
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This is a randomized, controlled, single-center study in otherwise healthy infertile female subjects undergoing in vitro fertilization (IVF). The subjects recruited for this study will be among those patients who have been diagnosed with infertility and are planning to undergo IVF at the center where this study is being performed. The subjects will have undergone the usual informed consent procedure at the center. Subjects will undergo ovarian stimulation, oocyte retrieval, IVF, and Intra Cytoplasmic Sperm Injection (ICSI) procedure following the center's usual procedures. At the time of retrieval, participant's oocytes will be randomly assigned to both groups for comparison: Standard EmbryoScope Time-Lapse system versus EmbryoScope+. The best quality embryos are selected for embryo transfer and the pregnancy outcome is evaluated. Best grade embryos will be transferred regardless of EmbryoScope use. The standard EmbryoScope as well as the EmbryoScope+ monitor system as assigned during the randomization process will be used to observe the embryo development and document timing of embryo cleavages and morphology dynamics. Subjects will not be provided with the time- lapse images. Endpoints will be Day 3 and Day 5/6 embryo development, implantation and pregnancy rate. The study is approximately 2 months, the estimated time it takes a physician to perform one IVF-ART treatment cycle. If embryos are frozen, the patient may be in the study until the time they choose to thaw the embryos or up to 1 year if they become pregnant.

Official Title
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Randomized Controlled Trial Comparing EmbryoScope Time-Lapse System With the New Model EmbryoScope+.

Conditions
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Infertility

Intervention / Treatment
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* Device: EmbryoScope
* Device: EmbryoScope+


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 40 years of age or younger (maternal) 65 years of age or younger (paternal) Fresh or frozen (including donor) sperm can be used Fresh oocytes only (including donor) Frozen embryos from this study can be included in the outcome portion of this study. Single or double Blastocyst transfer only Exclusion Criteria: 3 or more previous failed cycles Sperm obtained by testicular biopsy Co-culture patients

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: EmbryoScope<br>Standard of care embryo incubator. | Device: EmbryoScope<br>* Standard of care arm<br>|
| Experimental: EmbryoScope+<br>New experimental embryo incubator. | Device: EmbryoScope+<br>* Experimental arm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Day 3 Embryos | Comparing number of embryos that fertilized normally and had development at Day 3 based on embryo grade between oocytes assigned to Standard EmbryoScope versus oocytes assigned to EmbryoScope+ | Day 3 post retrieval | 
| Number of Day 5 Embryos | Comparing the number pf embryos that developed at Day 5 based on embryo grade between oocytes assigned to Standard EmbryoScope versus oocytes assigned to EmbryoScope+ | Day 5 post retrieval | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implantation Rate | Presence of a gestational sac | 5-6 weeks post retrieval | 
| Pregnancy Rate | Positive Bhcg | 2 weeks post retrieval | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IVF, Infertility, Embryo develpoment, ICSI, EmbryoScope