Clinical trial NCT03164551: TICON-Day 3, Time Lapse Versus Conventional Method in Day 3 Embryo Culture and Assessment
Official title: A Phase IV, Single-blinded, Prospective, Randomized, Controlled, Multi-center Study to Compare the Clinical Outcomes of Genea Embryo Review Instrument Plus (GERI+) Time Lapse System With a Conventional Embryo Culture and Assessment System
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Infertility
Keywords: GERI+
TICON
EEVA
Embryo culture
In Vitro Fertilization
Intracytoplasmic Sperm Injection
Lead sponsor: Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
First posted: 2017-05-23
Enrollment: 408
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main purpose of the study was to evaluate the overall clinical value of GERI+ as an integrated embryo culture and assessment system, providing an undisturbed culture environment, continuous monitoring of embryo development and automated scoring using a predictive algorithm.


Eligibility criteria: Inclusion Criteria:

* Couples with less than or equal to (\<= ) two failed fresh In Vitro Fertilization/Intracytoplasmic Sperm Injection (IVF/ICSI) embryo transfer cycles
* Age greater than or equal to (\>=) 18 and \<= 40 years
* Body mass index (BMI): 18-30 kilogram per meter square (kg/m2)
* Normal uterine cavity under ultrasound
* Participant and her husband/partner must have read and signed the Informed Consent form (ICF)
* At least four normally fertilized oocytes (2Pronuclear stage (PN)) in the current cycle

Exclusion Criteria:

* Male with non-ejaculated sperm
* Participants with abnormal, undiagnosed gynecological bleeding or with genitourinary malformations
* Participants with any contraindication to Controlled Ovarian Stimulation (COS) for Assisted Reproductive Technologies (ART) or to gonadotropins
* Planned "freeze all" cycle (oocytes or embryos)
* Planned preimplantation genetic screening (PGS) or Pre-implantation genetic diagnosis (PGD) cycle
* Concurrent participation in another clinical study

Primary outcomes:
measure: Clinical Pregnancy Rate With Positive Fetal Heart Beat (FHB)
timeFrame: Gestation Weeks 6 to 8
Secondary outcomes:
measure: Utilizable Embryos Rate
timeFrame: Day 3 of embryo culture
measure: Good Quality Embryos Rate
timeFrame: Day 3 of embryo culture
measure: Non-viable Embryos Rate
timeFrame: Days 1 to 3 of embryo culture
measure: Implantation Rate (IR) With Positive Fetal Heart Beat
timeFrame: Gestational Weeks 6 to 8
measure: Biochemical Pregnancy Rate
timeFrame: From Day 12 of Gestational up to Week 8
measure: Ongoing Pregnancy Rate
timeFrame: Gestational Weeks 10 to 12
measure: Multiple Pregnancy Rate
timeFrame: Gestational Weeks 10 to 12
measure: Ectopic Pregnancy Rate
timeFrame: Gestational Weeks 6 to 8
measure: Spontaneous Miscarriage Rate
timeFrame: Gestational Weeks 10 to 12
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Cambrian Wellness Centre
city: Calgary
country: Canada
facility: Regional Fertility Program
city: Skive
country: Denmark
facility: Skive Fertility clinic
city: Skive
country: Denmark
facility: Fertility Clinic Skive Regional Hospital
city: Clamart
country: France
facility: Hopital Antoine Beclere
city: Bruneck (BZ)
country: Italy
facility: Krankenhaus Bruneck
city: Firenze
country: Italy
facility: Demetra S.R.L
city: Firenze
country: Italy
facility: Futura Diagnostica medica PMA SRL
city: Viareggio
country: Italy
facility: USL Toscana Nordovest
city: Oslo
country: Norway
facility: Oslo University Hospital
city: Skien
country: Norway
facility: Sykehuset Telemark HF Fertilitetsavdeliningen Sor
city: Trodheim
country: Norway
facility: St. Olavs Hospital Hf, Universitetssykehuset i Trondheim
city: Coimbra
country: Portugal
facility: Centro Hospitalar e Universitario de Coimbra
city: Baracaldo
country: Spain
facility: Hospital de Cruces
city: Barcelona
country: Spain
facility: Nephrology Service Fundacion Puigvert
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves
city: Santa Cruz de Tenerife
country: Spain
facility: Hosp Univ de Canarias
Study officials:
affiliation: Merck KGaA, Darmstadt, Germany
name: Medical Responsible
role: STUDY_DIRECTOR
References: