TiLE (Time Lapse Eeva) Clinical Trial (TiLE)

January 29, 2020 updated by: Merck KGaA, Darmstadt, Germany

A Phase IV, Prospective, Randomized, Exploratory, Multicenter, Eeva™ Trial (Time Lapse Eeva - TiLE)

The purpose of the study was to explore the added value of adjunctive use of Early Embryo Viability Assessment (Eeva) with morphological grading in identifying optimal embryos for transfer.

Study Overview

Status

Status

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

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

This study is a Phase IV, open label, prospective, randomized, exploratory, multicenter study. Subjects were randomized in 2:1 ratio to two treatment groups: in the experimental group, embryos were assessed for embryo transfer (ET) with Eeva and morphological grading, while in the control group embryos were assessed with morphological grading only.

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.
976

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.
  • Phase 4

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

  • Canada
      • Toronto, Canada
        • Mount Sinai Hospital
    • Alberta
      • Calgary, Alberta, Canada
        • Cambrian Wellness Centre
    • Ontario
      • Burlington, Ontario, Canada
        • ONE Fertility
      • Mississauga, Ontario, Canada
        • ISIS Regional Fertility Clinic
  • Denmark
      • Copenhagen, Denmark
        • Rigshospitalet
  • France
      • Lille Cedex, France
        • CHRU - Hopital Jeanne de Flandres
      • Marseille, France
        • Laboratoire Alphabio & Institut de Médecine de la Reproducti
      • Nantes, France
        • Hôpital Hôtel Dieu
  • Germany
      • Luebeck, Germany
        • Universitätsklinik Schleswig-Holstein
      • Munich, Germany
        • Kinderwunsch Centrum München
      • Wiesbaden, Germany
        • MVZ Kinderwunschzentrum Wiesbaden GmbH
  • Italy
      • Montichiari, Italy
        • Montichiari Università degli studi di Bresca
      • Rozzano, Italy
        • Istituto Clinico Humanitas
      • Torino, Italy
        • Università degli Studi Torino
      • Viareggio, Italy
        • Ospedale Versilia
  • Norway
      • Skien, Norway
        • Telemark hospital Porsgrunn
  • Spain
      • Alicante, Spain
        • Clinica Vistahermosa
      • Barcelona, Spain
        • Clinica Sagrada Familia
      • Granada, Spain
        • Hospital Universitario Virgen de las Nieves
  • Sweden
      • Stockholm, Sweden
        • Fertilitetscentrum Stockholm
  • United Kingdom
      • Cambridge, United Kingdom
        • Bourn Hall
      • Edgbaston, United Kingdom
        • Birmingham Women's Health Care NHS Trust
      • London, United Kingdom
        • Homerton University Hospital

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

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • All infertile subjects treated with In vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI)
  • Subject age less than or equal to (<=) 40 years
  • Less than or equal to (<=) 3 failed IVF/ICSI cycles
  • At least 4 normally fertilized eggs (2 pronuclei [2PN]) in current cycle
  • Normal uterine cavity
  • Fertilization using only ejaculated sperm (fresh or frozen)
  • Subject must have read and signed the Informed Consent Form

Exclusion Criteria:

  • Have clinically significant systemic disease
  • Have abnormal, undiagnosed gynecological bleeding
  • Have any contraindication to Controlled Ovarian Stimulation (COS) for assisted reproductive technologies (ART) and to gonadotropins to be used in ART
  • Egg donor cycle
  • Planned "freeze all" cycle (oocytes or embryos)
  • Concurrent participation in another clinical trial

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

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.
Experimental: Early Embryo Viability Assessment + Morphological Grading
Embryos of subjects randomized in this group were assessed using Early Embryo Viability Assessment (Eeva) System and morphological grading to identify optimal embryos for transfer.
Device: Eeva
Embryos of subjects randomized in this group were assessed using Eeva System and morphological grading to identify optimal embryos for transfer.
No Intervention: Morphological Grading
Embryos of subjects randomized in this group were assessed only using morphological grading to identify optimal embryos for transfer.

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
Implantation Rate
Time Frame: Gestational Weeks 5 to 8
Implantation rate was calculated by dividing the number of intrauterine gestational sacs by the number of embryos transferred multiplied by 100.
Gestational Weeks 5 to 8

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
Clinical Pregnancy Rate
Time Frame: Gestational Weeks 5 to 8
Clinical pregnancy was confirmed by the presence of a gestational sac with heartbeat as assessed by ultrasonography. Clinical pregnancy rate was measured as the number of clinical pregnancies divided by number of embryo transfer (ET) cycles multiplied by 100.
Gestational Weeks 5 to 8
Number of Subjects With Ongoing Pregnancy Status
Time Frame: Gestational Weeks 10 to 12
Ongoing pregnancy was defined as having a positive fetal heart beat (FHB) as assessed by ultrasonography at gestational week 10-12. Number of subjects with ongoing pregnancy status has been reported, where "Yes" indicates participants with positive ongoing pregnancy status and "No" indicates participants with negative ongoing pregnancy status .
Gestational Weeks 10 to 12
Multiple Pregnancy Rate
Time Frame: Gestational Weeks 5 to 8
Multiple pregnancy rate was defined as a clinical pregnancy with greater than equals to (>=) 2 fetal sacs as assessed by ultrasonography. Multiple Pregnancies rate was measured by number of multiple pregnancies divided by number of embryo transfer cycles multiplied by 100.
Gestational Weeks 5 to 8
Utilization Rate
Time Frame: Day 3 or Day 5/6 of embryo culture
Utilization rate was defined as the sum of number of transferred and frozen embryos divided by number of normally fertilized oocytes multiplied by 100.
Day 3 or Day 5/6 of embryo culture
Spontaneous Miscarriage Rate
Time Frame: Gestational Weeks 10 to 12
Spontaneous miscarriage rate was measured by the number of spontaneous miscarriages as communicated during medical appointment or by telephone contact divided by number of clinical pregnancies multiplied by 100.
Gestational Weeks 10 to 12

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Eeva Conformity in Early Embryo Viability Assessment + Morphological Grading Group for Day 3 Embryo Transfer (ET)
Time Frame: Day 3 of embryo culture
Eeva Conformity was reported as the number of subjects who were compliant to use Eeva in embryo assessment in the "Early Embryo Viability Assessment + morphological grading" group. Eeva-compliance subgroup refers to subjects whose embryos were assessed by embryologists following the recommendation of Eeva system and the instructions for use (IFU) of Eeva. Subgroup analysis revealed a high incidence of Eeva noncompliance in the experimental group, which compromised the quality of this study. Only "Early Embryo Viability Assessment + Morphological Grading" reporting arm was applicable for this outcome measure.
Day 3 of embryo culture
Eeva Conformity in Early Embryo Viability Assessment + Morphological Grading Group for Day 5/6 Embryo Transfer (ET)
Time Frame: Day 5/6 of embryo culture
Eeva Conformity was reported as the number of subjects who were compliant to use Eeva in embryo assessment in the "Early Embryo Viability Assessment + morphological grading" group. Eeva-compliance subgroup refers to subjects whose embryos were assessed by embryologists following the recommendation of Eeva system and the IFU of Eeva. Subgroup analysis revealed a high incidence of Eeva noncompliance in the experimental group, which compromised the quality of this study. Only "Early Embryo Viability Assessment + Morphological Grading" reporting arm was applicable for this outcome measure.
Day 5/6 of embryo culture

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.
Merck KGaA, Darmstadt, Germany

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.
June 29, 2015

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.
February 9, 2017

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.
February 9, 2017

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).
April 10, 2015

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.
April 10, 2015

First Posted (Estimate)

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.
April 15, 2015

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.
January 30, 2020

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.
January 29, 2020

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.
January 1, 2020

More Information

Terms related to this study

Keywords

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.
  • EMR700623_545

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.

Clinical Trials on Fertility

Clinical Trials on Eeva

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings