Selection of the Embryo to Transfer by Morphokinetics vs. Morphological Evaluation.
EmbryoSEL
1 other identifier
interventional
228
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 26, 2017
CompletedFirst Submitted
Initial submission to the registry
June 26, 2019
CompletedFirst Posted
Study publicly available on registry
July 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedMay 20, 2020
May 1, 2020
3.9 years
June 26, 2019
May 19, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Pregnancy Rate
Positive pregnancy test
12-14 days after the embryo transfer
Secondary Outcomes (1)
Clinical Pregnancy Rate
12-15 days after the positive blood test for pregnancy
Study Arms (2)
GROUP A: Morphological embryo selection
NO INTERVENTIONPatients enrolled in group A will receive an embryo transfer according to classical morphological criteria.
GROUP B: Morpho-kinetics embryo selection
ACTIVE COMPARATORPatients enrolled in group B will receive an embryo transfer according to new morphokinetics criteria.
Interventions
Embryos in group B will be selected in blastocyst stage according to morpho-kinetics criteria before the embryo transfer
Eligibility Criteria
You may qualify if:
- Egg-donation IVF patients
- IVF patients if \< 38 years
- Sperm concentration \> 2 million/ml
- Frozen eggs for
- Single embryo transfer
- ICSI fertilization
You may not qualify if:
- Uterine pathologies that may interfere with implantation
- Endometriosis
- Frozen eggs
- Pre implantation genetic testing of the embryos
- Day 3 embryo transfer
- Conventional IVF treatments
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Procreateclead
- Sociedad Espanola Fertilidadcollaborator
Study Sites (1)
Procreatec
Madrid, 28036, Spain
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lourdes Lopez
Procreatec
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Masking Details
- 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.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 26, 2019
First Posted
July 1, 2019
Study Start
January 26, 2017
Primary Completion
December 31, 2020
Study Completion
December 31, 2020
Last Updated
May 20, 2020
Record last verified: 2020-05