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

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

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.

Study Overview

• Status: Unknown
• Conditions: Embryo Implantation
• Intervention / Treatment: Other: Morpho-kinetics selection with time-lapse (Embryoscope) evaluation

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 Type: Interventional
• Enrollment (Anticipated): 228
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ester Padilla; Phone Number: 24 0034914585804; Email: esterpadilla@procreatec.com
• Study Contact Backup: Name: Lourdes Lopez; Phone Number: 0034914585804; Email: lopezyanez@procreatec.com

Study Locations

• Spain
  • Madrid, Spain, 28036
    • Recruiting
    • ProcreaTec
    • Contact: Lourdes Lopez, MD; Phone Number: 0034914585804; Email: lopezyanez@procreatec.com
    • Contact: Katharina Spies, MD; Phone Number: 28 0034914585804; Email: katharina.spies@procreatec.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: GROUP A: Morphological embryo selection; Patients enrolled in group A will receive an embryo transfer according to classical morphological criteria.
Active Comparator: GROUP B: Morpho-kinetics embryo selection; Patients enrolled in group B will receive an embryo transfer according to new morphokinetics criteria.	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Procreatec
• Collaborators: Sociedad Espanola Fertilidad
• Investigators: Principal Investigator: Lourdes Lopez, ProcreaTec

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2017
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: June 26, 2019
• First Submitted That Met QC Criteria: June 27, 2019
• First Posted (Actual): July 1, 2019

Study Record Updates

• Last Update Posted (Actual): May 20, 2020
• Last Update Submitted That Met QC Criteria: May 19, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: EmbryoSEL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No