TiLE (Time Lapse Eeva) Clinical Trial

Phase 4

Completed

• Conditions: Fertility

• Registration Number: NCT02417441
• Lead Sponsor: Merck KGaA, Darmstadt, Germany

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.

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 Timeline

• Study First Submitted: 2015-04-10
• Study First Submitted QC: 2015-04-10
• Study First Posted: 2015-04-15
• Study Start: 2015-06-29
• Primary Completion: 2017-02-09
• Study Completion: 2017-02-09
• Results First Submitted: 2018-02-08
• Results First Submitted QC: 2019-04-09
• Results First Posted: 2019-04-29
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-29
• Last Update Posted: 2020-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 976

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Implantation Rate	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

Name	Time	Method
Clinical Pregnancy Rate	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.
Number of Subjects With Ongoing Pregnancy Status	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 .
Multiple Pregnancy Rate	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.
Utilization Rate	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.
Spontaneous Miscarriage Rate	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.

Trial Locations

Locations (23)

Cambrian Wellness Centre; 🇨🇦 Calgary, Alberta, Canada

One Fertility; 🇨🇦 Burlington, Ontario, Canada

ISIS Regional Fertility Clinic; 🇨🇦 Mississauga, Ontario, Canada

Mount Sinai Hospital; 🇨🇦 Toronto, Canada

Rigshospitalet; 🇩🇰 Copenhagen, Denmark

CHRU - Hopital Jeanne de Flandres; 🇫🇷 Lille Cedex, France

Laboratoire Alphabio & Institut de Médecine de la Reproducti; 🇫🇷 Marseille, France

Hopital Hotel Dieu; 🇫🇷 Nantes, France

Universitatsklinik Schleswig-Holstein; 🇩🇪 Luebeck, Germany

Kinderwunsch Centrum München; 🇩🇪 Munich, Germany

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