Embryo ImplantationEmbryoSELNCT04003337
Selection of the Embryo to Transfer by Morphokinetics vs. Morphological Evaluation.
A study testing Morpho-kinetics selection with time-lapse (Embryoscope) evaluation in people with Embryo Implantation, run by Procreatec at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Embryo Implantation
- What is being tested?
- Morpho-kinetics selection with time-lapse (Embryoscope) evaluation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- 1 siteSpain
- Study dates
- 26 Jan 2017to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Egg-donation IVF patients
- IVF patients if < 38 years
- Sperm concentration > 2 million/ml
- Frozen eggs for
- Single embryo transfer
- ICSI fertilization
Who cannot join
- Uterine pathologies that may interfere with implantation
- Endometriosis
- Frozen eggs
- Pre implantation genetic testing of the embryos
- Day 3 embryo transfer
- Conventional IVF treatments
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Procreatec
Madrid, 28036
Lourdes Lopez, MD, 0034914585804, lopezyanez@procreatec.com
Katharina Spies, MD, 0034914585804 ext. 28, katharina.spies@procreatec.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Embryo Implantation
- Being tested
- Morpho-kinetics selection with time-lapse (Embryoscope) evaluation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Morpho-kinetics selection with time-lapse (Embryoscope) evaluationOther
Embryos in group B will be selected in blastocyst stage according to morpho-kinetics criteria before the embryo transfer
| Study group | Role | What they receive |
|---|---|---|
| GROUP A: Morphological embryo selection | No intervention | Patients enrolled in group A will receive an embryo transfer according to classical morphological criteria. |
| GROUP B: Morpho-kinetics embryo selection | Active comparator | Patients enrolled in group B will receive an embryo transfer according to new morphokinetics criteria. Receives: Other: Morpho-kinetics selection with time-lapse (Embryoscope) evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy Rate
Positive pregnancy test
Measured: 12-14 days after the embryo transfer
Secondary outcomes (1)
Clinical Pregnancy Rate
US pregnancy confirmation
Measured: 12-15 days after the positive blood test for pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2019
- Study start26 Jan 2017
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Embryo ImplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two arms interventional prospective randomized controlled trial.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 228 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Procreatec
- Sponsor type
- University, hospital or other
- Collaborators
- Sociedad Espanola Fertilidad
- Responsible party
- Sponsor
- Investigators
- Lourdes Lopez, Principal investigator, Procreatec
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04003337
- Sponsor's protocol ID
- EmbryoSEL
- Acronym
- EmbryoSEL
- Status last verified
- May 2020
- First submitted
- 26 Jun 2019
- Last updated
- 20 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selection of the Embryo to Transfer by Morphokinetics vs. Morphological Evaluation. Prospective and Randomized Trial of Patients Using Time-lapse (Embryoscope®).
- ClinicalTrials.gov ID
- NCT04003337
- Acronym / sponsor ID
- EmbryoSEL / EmbryoSEL
- Conditions
- Embryo Implantation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 228 participants (estimated)
- Lead sponsor
- ProcreatecUniversity, hospital or other
- Collaborators
- Sociedad Espanola Fertilidad
- Study start
- 26 Jan 2017 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 1 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Two arms interventional prospective randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| GROUP A: Morphological embryo selection | No intervention | –Patients enrolled in group A will receive an embryo transfer according to classical morphological criteria. |
| GROUP B: Morpho-kinetics embryo selection | Active comparator | Other: Morpho-kinetics selection with time-lapse (Embryoscope) evaluationPatients enrolled in group B will receive an embryo transfer according to new morphokinetics criteria. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Egg-donation IVF patients
- IVF patients if < 38 years
- Sperm concentration > 2 million/ml
- Frozen eggs for
- Single embryo transfer
Key exclusion criteria (6 listed)
- Uterine pathologies that may interfere with implantation
- Endometriosis
- Frozen eggs
- Pre implantation genetic testing of the embryos
- Day 3 embryo transfer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Morpho-kinetics selection with time-lapse (Embryoscope) evaluationEmbryos in group B will be selected in blastocyst stage according to morpho-kinetics criteria before the embryo transfer | Other | GROUP B: Morpho-kinetics embryo selection |
Primary outcome
Pregnancy Rate
Time frame: 12-14 days after the embryo transfer
Positive pregnancy test
1 secondary outcome
Clinical Pregnancy Rate
Time frame: 12-15 days after the positive blood test for pregnancy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Embryo Implantation
Recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic
RecruitingObservational study
dPmax for Predicting Right Ventricular Failure After Left Ventricular Assist Device Implantation
Ventricular Dysfunction, Right
RecruitingObservational study
Retrospectively Investigating Longitudinal Outcomes in MED-EL SONATA 2 Cochlear Implant Recipients.
Cochlear Implantation, Sensorineural Hearing Loss
Not yet recruitingObservational study
Evaluation of a Management Algorithm for TAVI Patients With Concomitant Mitral or Tricuspid Regurgitation
Aortic Stenosis, Mitral Regurgitation
Recruiting
Ambulatory Electrocardiographic Monitoring for the Detection of High-Degree Atrio-Ventricular Block in Patients With New-onset PeRsistent LEft Bundle Branch Block After Transcatheter Aortic Valve Implantation. The "MARE" Study
Aortic Valve Disease, Conduction Disturbances
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lourdes Lopez principal investigator
Procreatec
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Morpho-kinetics selection with time-lapse (Embryoscope) evaluation in people with Embryo Implantation, run by Procreatec at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ester Padilla (0034914585804 ext. 24, esterpadilla@procreatec.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pregnancy Rate (time frame: 12-14 days after the embryo transfer). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2020.