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
|Condition or disease||Intervention/treatment||Phase|
|Embryo Implantation||Other: Morpho-kinetics selection with time-lapse (Embryoscope) evaluation||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||228 participants|
|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.|
|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|
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
- Pregnancy Rate [ Time Frame: 12-14 days after the embryo transfer ]Positive pregnancy test
- Clinical Pregnancy Rate [ Time Frame: 12-15 days after the positive blood test for pregnancy ]US pregnancy confirmation
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
|Contact: Ester Padilla||0034914585804 ext email@example.com|
|Contact: Lourdes Lopezfirstname.lastname@example.org|
|Principal Investigator:||Lourdes Lopez||Procreatec|