Can Time-lapse Parameters be Used to Predict Pregnancy of Human Embryos?

October 13, 2021 updated by: Thorir Hardarson, Fertilitetscentrum AB
All patients starting an IVF-treatment at the clinics, and meeting the inclusion criteria, will be offered to participate in the study. Randomization will be performed on day 5 and the patients will be allocated into either morphology only group or time-lapse group. Embryos will be cultured to day five according to the clinics own routines. All embryos in both groups will be cultured using time-lapse incubation. In the control group the embryo selection will be based only on traditional morphological evaluation and in the treatment group a time-lapse selection model (KID Score day 5) will be used to select the embryo.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The aim is to study if algorithm calculated from time-lapse photography of human embryos per se can enhance the prediction of the embryo´s reproductive potential compared to embryo morphology alone.

METHODS AND MATERIAL IVF procedure Oocytes retrieved 36±1h after hCG administration will be fertilized by either standard insemination or ICSI. The morning after oocyte retrieval (day 1) zygotes will be placed into embryo time-lapse slides for culture up to the day of transfer (day 5). During the culture time, embryos will be kept in commercially available culture media and will not be removed from the time-lapse incubator until day of transfer. Embryos interact with the media and will be allowed to develop the blastocyst stage (5-6 days culture) at which time selection for transfer will be made. During the in vitro culture a single image captured in the time-lapse incubator will be used to routinely morphologically grade embryos, according to the Istanbul consensus. On day 5, developing embryos will be assessed (according to study vs. control group criteria) to select the embryo for transfer into the patient. Supernumerous GQE will be cryopreserved for future use.

Time-lapse photography All embryos will be placed in wells of time-lapse culture dishes (Embryoscope) according to the instructions of the manufacturer. Embryos in both groups will be cultured to the blastocyst stage without any media change. The time-lapse system is comprised of a desktop incubator that controls it´s environment (pH, CO2 and O2) as well as taking pictures in up to 11 focal planes for the whole duration of the culture periods.

Morphological scoring Embryo morphology will be scored according to the Gardner score and then translated to the Istanbul consensus system if needed for publication.

To assure that all embryologists annotate the embryo development correctly as well as score the blastocysts in the same way, a validation process will be performed before the onset of the study. The standardization will be accomplished through a process where the embryologists will score 20 blastocysts at day 5-development stage, which will be provided on a CD, imitating the procedure will be performed routinely in the laboratory. The embryologists will have to be approved in order to be allowed to score embryos in the study.

Embryo evaluation (both groups). Embryos will be cultured in the Embryoscope time-lapse system until day 5. If two or more blastocyst of good quality (GQB), i.e. fulfilling a minimum morphological criteria of 3BB or better, develop, a preliminary decision is made on which embryo to select for transfer. Thereafter the couple is randomized into either the control or the time-lapse group.

Decision making in the time-lapse group If the couple is randomized into the time-lapse group all embryos that have reached the blastocyst stage will be annotated. The blastocyst with the highest KID (day 5) score will be chosen for transfer. To ensure a reliable KID scores can be attained the morphological events; time to 2, 3, 4, and 5 cells, time to start of blastulation (tSB), and TE scores must be evaluated.

Decision making in the control group If the couple are randomized to the control group, the preliminary embryo selection decision will be maintained.

Study monitoring. A Data Study Monitoring Board (DSMB) Group will be assigned and have the task of conducting both safety checks and an interim analysis (planned when ca 50% of the patients have been recruited).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
776

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iceland
      • Reykjavík, Iceland
        • Livio Reykjavik
  • Norway
      • Oslo, Norway
        • Livio Oslo
  • Sweden
      • Falun, Sweden
        • Livio Falun
      • Gothenburg, Sweden
        • Fertilitetscentrum Livio Göteborg
      • Gothenburg, Sweden
        • Sahlgrenska Universitetssjukhuset
      • Malmö, Sweden
        • Livio Malmö
      • Stockholm, Sweden
        • Karolinska Universtetssjukhuset
      • Stockholm, Sweden
        • Livio Gärdet
      • Stockholm, Sweden
        • Livio Kungsholmen
      • Stockholm, Sweden
        • Sophiahemmet
      • Umeå, Sweden
        • Livio Umeå

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years to 41 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Couples undergoing IVF or ICSI (intracytoplasmic sperm injection) that do not meet the exclusion criteria.
  • The couple shall receive and sign written information about the study.
  • On day 5, before the randomization the couple must have at least 2 transferrable blastocysts in order to be included in the study.

Exclusion Criteria:

  • If double embryo transfer, for any reason, is planned.
  • Prior participation in the study.
  • Pre-implantation genetic diagnosis (PGD) treatment.
  • Embryo transfer on another day than day 5.
  • Oocyte cryopreservation.
  • Planned total freeze of embryos for any reason (cancer, OHSS etc.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Morphology
Embryos for transfer will be selected based on standard morphological evaluation.
Active Comparator: TLM
Embryos for transfer will be selected base on standard morphological evaluation and information from time-lapse monitoring.
Other: Time lapse monitoring (KID Score)
The unique information that is obtainable from taking Pictures each 10 minutes throughout the development of the embryos will be used in the form of a special score (KID score). The score is comprised out of several key developmental parameters.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Ongoing pregnancy (week 6-7)
Time Frame: Patient is assessed 6-7 weeks after embryo transfer
A confirmed pregnancy by ultrasound in the 6-7th week of gestation.
Patient is assessed 6-7 weeks after embryo transfer

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Positive pregnancy tests, 18 days after embryo transfer.
Time Frame: Patient is assessed 2 weeks after embryo transfer by taking a pregancy test
A pregnancy test is taken (Urine).
Patient is assessed 2 weeks after embryo transfer by taking a pregancy test
Early pregnancy loss (positive pregnancy test but no gestational sac observed at sonography)
Time Frame: Same time frame as for the primary outcome i.e. 6-7 weeks.
This is the loss of pregnancy between positive pregnancy test (2 weeks) and ultrasound (6-7 weeks)
Same time frame as for the primary outcome i.e. 6-7 weeks.
Correlation between the preliminary decisions of embryo fate based only on morphology and the final decision made by time-lapse
Time Frame: Can be made on the day of transfer (1 hour between primary and seconday decision).
In the time-lapse Group we plan to compare the decision made based solely on morphology (Before the KID score is made) and after the KID score has been applied.
Can be made on the day of transfer (1 hour between primary and seconday decision).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fertilitetscentrum AB

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 29, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 20, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 23, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 26, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 21, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 13, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 954-17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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