Selection of the Embryo to Transfer by Morphokinetics vs. Morphological Evaluation.

Study Overview
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Brief Summary
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Our study intends to demonstrate that the selection of an embryo to transfer it at the sage of blastocyst through morphokinetics (analysis of embryos depending not only in their morphology -that is, the aspect of the embryo-, but also based on times of cell division) during the use of time-lapse (Embryoscope®) may have a better impact in clinical results, as selection is not performed in mere morphological evolution (visual aspect of the embryo) of the embryos.

Detailed Description
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Our study intends to demonstrate that the selection of an embryo to transfer it at the sage of blastocyst through morphokinetics (analysis of embryos depending not only in their morphology -that is, the aspect of the embryo-, but also based on times of cell division) during the use of time-lapse (Embryoscope®) may have a better impact in clinical results, as selection is not performed in mere morphological evolution (visual aspect of the embryo) of the embryos. In order to obtain this objective, patients participating in the study will be randomly assigned to one of the following groups: Group A: Patients who will perform an embryo transfer of a blastocyst using morphological criteria to evaluate que quality of the blastocyst (Gardner Classification), that is, based on the aspect or form of the embryo. Group B: Patients who will perform an embryo transfer of a blastocyst using morphokinetics criteria to evaluate the quality of the blastocyst (Embryoscope®), that is, based not only in the aspect of the embryo but also in cell division times experimented by the embryos.

Official Title
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Selection of the Embryo to Transfer by Morphokinetics vs. Morphological Evaluation. Prospective and Randomized Trial of Patients Using Time-lapse (Embryoscope®).

Conditions
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Embryo Implantation

Intervention / Treatment
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* Other: Morpho-kinetics selection with time-lapse (Embryoscope) evaluation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Egg-donation IVF patients IVF patients if < 38 years Sperm concentration > 2 million/ml Frozen eggs for Single embryo transfer ICSI fertilization Exclusion Criteria: Uterine pathologies that may interfere with implantation Endometriosis Frozen eggs Pre implantation genetic testing of the embryos Day 3 embryo transfer Conventional IVF treatments

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two arms interventional prospective randomized controlled trial.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: GROUP A: Morphological embryo selection<br>Patients enrolled in group A will receive an embryo transfer according to classical morphological criteria. | |
| Active Comparator: GROUP B: Morpho-kinetics embryo selection<br>Patients enrolled in group B will receive an embryo transfer according to new morphokinetics criteria. | Other: Morpho-kinetics selection with time-lapse (Embryoscope) evaluation<br>* Embryos in group B will be selected in blastocyst stage according to morpho-kinetics criteria before the embryo transfer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy Rate | Positive pregnancy test | 12-14 days after the embryo transfer | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Pregnancy Rate | US pregnancy confirmation | 12-15 days after the positive blood test for pregnancy |