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

Not Applicable

• Conditions: Embryo Implantation
• Interventions: Other: Morpho-kinetics selection with time-lapse (Embryoscope) evaluation

• Registration Number: NCT04003337
• Lead Sponsor: Procreatec

Brief Summary

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

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.

Study Timeline

• Study Start: 2017-01-26
• Study First Submitted: 2019-06-26
• Study First Submitted QC: 2019-06-27
• Study First Posted: 2019-07-01
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-19
• Last Update Posted: 2020-05-20
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 228

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GROUP B: Morpho-kinetics embryo selection	Morpho-kinetics selection with time-lapse (Embryoscope) evaluation	Patients enrolled in group B will receive an embryo transfer according to new morphokinetics criteria.

Primary Outcome Measures

Name	Time	Method
Pregnancy Rate	12-14 days after the embryo transfer	Positive pregnancy test

Secondary Outcome Measures

Name	Time	Method
Clinical Pregnancy Rate	12-15 days after the positive blood test for pregnancy	US pregnancy confirmation

Trial Locations

Locations (1)

Procreatec; 🇪🇸 Madrid, Spain