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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

228 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-26

Study Completion Date

2020-12-31

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.

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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.

Conditions

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Embryo Implantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two arms interventional prospective randomized controlled trial.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Once patients accept to be enrolled in the study, one of the nurses will allocate the patient to one of study groups. Neither the patient nor the doctor will know the group assigned.

Study Groups

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GROUP A: Morphological embryo selection

Patients enrolled in group A will receive an embryo transfer according to classical morphological criteria.

Group Type NO_INTERVENTION

No interventions assigned to this group

GROUP B: Morpho-kinetics embryo selection

Patients enrolled in group B will receive an embryo transfer according to new morphokinetics criteria.

Group Type ACTIVE_COMPARATOR

Morpho-kinetics selection with time-lapse (Embryoscope) evaluation

Intervention Type OTHER

Embryos in group B will be selected in blastocyst stage according to morpho-kinetics criteria before the embryo transfer

Interventions

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Morpho-kinetics selection with time-lapse (Embryoscope) evaluation

Embryos in group B will be selected in blastocyst stage according to morpho-kinetics criteria before the embryo transfer

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No