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TiLE (Time Lapse Eeva) Clinical Trial (TiLE)

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ClinicalTrials.gov Identifier: NCT02417441
Recruitment Status : Completed
First Posted : April 15, 2015
Results First Posted : April 29, 2019
Last Update Posted : January 30, 2020
Sponsor:
Information provided by (Responsible Party):
Merck KGaA, Darmstadt, Germany

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Fertility Device: Eeva Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 976 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Phase IV, Prospective, Randomized, Exploratory, Multicenter, Eeva™ Trial (Time Lapse Eeva - TiLE)
Actual Study Start Date : June 29, 2015
Actual Primary Completion Date : February 9, 2017
Actual Study Completion Date : February 9, 2017
Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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 .

  3. 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.

  4. 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.

  5. 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.


Other Outcome Measures:
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02417441


Locations
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Sponsors and Collaborators
Merck KGaA, Darmstadt, Germany
Investigators
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Study Director: Medical Responsible Merck KGaA, Darmstadt, Germany
  Study Documents (Full-Text)

Documents provided by Merck KGaA, Darmstadt, Germany:
Study Protocol  [PDF] March 21, 2016
Statistical Analysis Plan  [PDF] February 20, 2017

More Information
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Responsible Party: Merck KGaA, Darmstadt, Germany
ClinicalTrials.gov Identifier: NCT02417441    
Other Study ID Numbers: EMR700623_545
First Posted: April 15, 2015    Key Record Dates
Results First Posted: April 29, 2019
Last Update Posted: January 30, 2020
Last Verified: January 2020
Keywords provided by Merck KGaA, Darmstadt, Germany:
TiLE
Embryo Assessment
Pregnancy
Implantation