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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04003337
Recruitment Status : Recruiting
First Posted : July 1, 2019
Last Update Posted : May 20, 2020
Sponsor:
Collaborator:
Sociedad Espanola Fertilidad
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Embryo Implantation Other: Morpho-kinetics selection with time-lapse (Embryoscope) evaluation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 228 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two arms interventional prospective randomized controlled trial.
Masking: Double (Participant, Care Provider)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Selection of the Embryo to Transfer by Morphokinetics vs. Morphological Evaluation. Prospective and Randomized Trial of Patients Using Time-lapse (Embryoscope®).
Actual Study Start Date : January 26, 2017
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

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




Primary Outcome Measures :
  1. Pregnancy Rate [ Time Frame: 12-14 days after the embryo transfer ]
    Positive pregnancy test


Secondary Outcome Measures :
  1. Clinical Pregnancy Rate [ Time Frame: 12-15 days after the positive blood test for pregnancy ]
    US pregnancy confirmation



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04003337


Contacts
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Contact: Ester Padilla 0034914585804 ext 24 esterpadilla@procreatec.com
Contact: Lourdes Lopez 0034914585804 lopezyanez@procreatec.com

Locations
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Spain
Procreatec Recruiting
Madrid, Spain, 28036
Contact: Lourdes Lopez, MD    0034914585804    lopezyanez@procreatec.com   
Contact: Katharina Spies, MD    0034914585804 ext 28    katharina.spies@procreatec.com   
Sponsors and Collaborators
Procreatec
Sociedad Espanola Fertilidad
Investigators
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Principal Investigator: Lourdes Lopez Procreatec
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Responsible Party: Procreatec
ClinicalTrials.gov Identifier: NCT04003337    
Other Study ID Numbers: EmbryoSEL
First Posted: July 1, 2019    Key Record Dates
Last Update Posted: May 20, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No