Clinical trial NCT02417441: TiLE (Time Lapse Eeva) Clinical Trial
Official title: A Phase IV, Prospective, Randomized, Exploratory, Multicenter, Eeva™ Trial (Time Lapse Eeva - TiLE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Fertility
Keywords: TiLE
Embryo Assessment
Pregnancy
Implantation
Lead sponsor: Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
First posted: 2015-04-15
Enrollment: 976
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility 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

Primary outcomes:
measure: Implantation Rate
timeFrame: Gestational Weeks 5 to 8
Secondary outcomes:
measure: Clinical Pregnancy Rate
timeFrame: Gestational Weeks 5 to 8
measure: Number of Subjects With Ongoing Pregnancy Status
timeFrame: Gestational Weeks 10 to 12
measure: Multiple Pregnancy Rate
timeFrame: Gestational Weeks 5 to 8
measure: Utilization Rate
timeFrame: Day 3 or Day 5/6 of embryo culture
measure: Spontaneous Miscarriage Rate
timeFrame: Gestational Weeks 10 to 12
Other outcomes:
measure: Eeva Conformity in Early Embryo Viability Assessment + Morphological Grading Group for Day 3 Embryo Transfer (ET)
timeFrame: Day 3 of embryo culture
measure: Eeva Conformity in Early Embryo Viability Assessment + Morphological Grading Group for Day 5/6 Embryo Transfer (ET)
timeFrame: Day 5/6 of embryo culture
Locations:
city: Calgary
country: Canada
facility: Cambrian Wellness Centre
state: Alberta
city: Burlington
country: Canada
facility: One Fertility
state: Ontario
city: Mississauga
country: Canada
facility: ISIS Regional Fertility Clinic
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hospital
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Lille Cedex
country: France
facility: CHRU - Hopital Jeanne de Flandres
city: Marseille
country: France
facility: Laboratoire Alphabio & Institut de Médecine de la Reproducti
city: Nantes
country: France
facility: Hopital Hotel Dieu
city: Luebeck
country: Germany
facility: Universitatsklinik Schleswig-Holstein
city: Munich
country: Germany
facility: Kinderwunsch Centrum München
city: Wiesbaden
country: Germany
facility: MVZ Kinderwunschzentrum Wiesbaden GmbH
city: Montichiari
country: Italy
facility: Montichiari Università degli studi di Bresca
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
city: Torino
country: Italy
facility: Università degli Studi Torino
city: Viareggio
country: Italy
facility: Ospedale Versilia
city: Skien
country: Norway
facility: Telemark hospital Porsgrunn
city: Alicante
country: Spain
facility: Clínica Vistahermosa
city: Barcelona
country: Spain
facility: Clinica Sagrada Familia
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves
city: Stockholm
country: Sweden
facility: Fertilitetscentrum Stockholm
city: Cambridge
country: United Kingdom
facility: Bourn Hall
city: Edgbaston
country: United Kingdom
facility: Birmingham Women's Health Care NHS Trust
city: London
country: United Kingdom
facility: Homerton University Hospital
Study officials:
affiliation: Merck KGaA, Darmstadt, Germany
name: Medical Responsible
role: STUDY_DIRECTOR
References: