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

Procreatec

Status: Unknown

Conditions: Embryo Implantation

Treatments: Other: Morpho-kinetics selection with time-lapse (Embryoscope) evaluation

Study type: Interventional

Funder types: Other

Identifiers

NCT04003337

EmbryoSEL

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 228 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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228 participants in 2 patient groups

GROUP A: Morphological embryo selection

No Intervention group

Description:

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

GROUP B: Morpho-kinetics embryo selection

Active Comparator group

Description:

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

Treatment:

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