Clinical trial NCT04003337: Selection of the Embryo to Transfer by Morphokinetics vs. Morphological Evaluation.
Official title: Selection of the Embryo to Transfer by Morphokinetics vs. Morphological Evaluation. Prospective and Randomized Trial of Patients Using Time-lapse (Embryoscope®).
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Embryo Implantation
Lead sponsor: Procreatec
Sponsor class: OTHER
Collaborators: name: Sociedad Espanola Fertilidad
First posted: 2019-07-01
Enrollment: 228
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two arms interventional prospective randomized controlled trial.
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Pregnancy Rate
timeFrame: 12-14 days after the embryo transfer
Secondary outcomes:
measure: Clinical Pregnancy Rate
timeFrame: 12-15 days after the positive blood test for pregnancy
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Procreatec
Study officials:
affiliation: Procreatec
name: Lourdes Lopez
role: PRINCIPAL_INVESTIGATOR
References: