TiLE (Time Lapse Eeva) Clinical Trial
- Conditions
- Fertility
- Interventions
- Device: Eeva
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 976
- 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
- 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
- Arm && Interventions
Group Intervention Description Early Embryo Viability Assessment + Morphological Grading Eeva 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.
- 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)
One Fertility
🇨🇦Burlington, Ontario, Canada
Cambrian Wellness Centre
🇨🇦Calgary, Alberta, Canada
Mount Sinai Hospital
🇨🇦Toronto, Canada
CHRU - Hopital Jeanne de Flandres
🇫🇷Lille Cedex, France
Universitatsklinik Schleswig-Holstein
🇩🇪Luebeck, Germany
Laboratoire Alphabio & Institut de Médecine de la Reproducti
🇫🇷Marseille, France
MVZ Kinderwunschzentrum Wiesbaden GmbH
🇩🇪Wiesbaden, Germany
Kinderwunsch Centrum München
🇩🇪Munich, Germany
Telemark hospital Porsgrunn
🇳🇴Skien, Norway
Montichiari Università degli studi di Bresca
🇮🇹Montichiari, Italy
Ospedale Versilia
🇮🇹Viareggio, Italy
Clinica Sagrada Familia
🇪🇸Barcelona, Spain
Fertilitetscentrum Stockholm
🇸🇪Stockholm, Sweden
Hospital Universitario Virgen de las Nieves
🇪🇸Granada, Spain
Bourn Hall
🇬🇧Cambridge, United Kingdom
Birmingham Women's Health Care NHS Trust
🇬🇧Edgbaston, United Kingdom
Rigshospitalet
🇩🇰Copenhagen, Denmark
Università degli Studi Torino
🇮🇹Torino, Italy
Homerton University Hospital
🇬🇧London, United Kingdom
Hopital Hotel Dieu
🇫🇷Nantes, France
Istituto Clinico Humanitas
🇮🇹Rozzano, Italy
ClÃnica Vistahermosa
🇪🇸Alicante, Spain
ISIS Regional Fertility Clinic
🇨🇦Mississauga, Ontario, Canada