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Completed

NCT Number: NCT02417441

TiLE (Time Lapse Eeva) Clinical Trial

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.

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Key information

Conditions

Fertility

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Cambrian Wellness Centre, Calgary, Alberta, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Eeva

Device

Embryos of subjects randomized in this group were assessed using Eeva System and morphological grading to identify optimal embryos for transfer.

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Merck KGaA, Darmstadt, Germany

Industry

Registry information

Official study title

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

Acronym: TiLE

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Apr 15, 2015
Registry last updated
Jan 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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