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

Embryo Implantation Clinical Trial

— EmbryoSEL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04003337
• Other study ID #: EmbryoSEL
• Status: Recruiting
• Phase: N/A
• Start date: January 26, 2017
• Est. completion date: December 31, 2020

Study information

• Verified date: May 2020
• Source: Procreatec
• Contact: Ester Padilla
• Phone: 0034914585804
• Email: esterpadilla[@]procreatec.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 228
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Embryo Implantation

Intervention

Other:
• 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

Locations

Country	Name	City	State
Spain	Procreatec	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Procreatec	Sociedad Espanola Fertilidad

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pregnancy Rate	Positive pregnancy test	12-14 days after the embryo transfer
Secondary	Clinical Pregnancy Rate	US pregnancy confirmation	12-15 days after the positive blood test for pregnancy