TICON-Day 3, Time Lapse Versus Conventional Method in Day 3 Embryo Culture and Assessment
NCT ID: NCT03164551
Last Updated: 2020-12-02
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE4
408 participants
INTERVENTIONAL
2018-04-16
2019-11-20
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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GERI+ Incubator
GERI+ incubator
The embryo culture of consented participants were carried out in GERI+ incubator for both bright-field and dark-field time lapse monitoring until Day 3 of embryo culture. On Day 3, all embryos were reviewed firstly by GERI Assess software, using bright-field imaging. Finally the embryo(s) with the highest EEVA grade are transferred were followed up until the achievement of implantation and confirmation of pregnancy.
Conventional incubator
Conventional incubator
The embryo culture of consented participants were carried out in conventional incubator for culture until Day 3 of embryo culture. On Day 3 of embryo culture, all embryos are assessed using a bench-top microscope. The embryo(s) with optimal cell stage and grade were transferred and were followed up until the achievement of implantation and confirmation of pregnancy.
Interventions
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GERI+ incubator
The embryo culture of consented participants were carried out in GERI+ incubator for both bright-field and dark-field time lapse monitoring until Day 3 of embryo culture. On Day 3, all embryos were reviewed firstly by GERI Assess software, using bright-field imaging. Finally the embryo(s) with the highest EEVA grade are transferred were followed up until the achievement of implantation and confirmation of pregnancy.
Conventional incubator
The embryo culture of consented participants were carried out in conventional incubator for culture until Day 3 of embryo culture. On Day 3 of embryo culture, all embryos are assessed using a bench-top microscope. The embryo(s) with optimal cell stage and grade were transferred and were followed up until the achievement of implantation and confirmation of pregnancy.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
40 Years
ALL
Yes
Sponsors
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Merck KGaA, Darmstadt, Germany
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Responsible
Role: STUDY_DIRECTOR
Merck KGaA, Darmstadt, Germany
Locations
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Cambrian Wellness Centre
Calgary, , Canada
Regional Fertility Program
Calgary, , Canada
Skive Fertility clinic
Skive, , Denmark
Fertility Clinic Skive Regional Hospital
Skive, , Denmark
Hopital Antoine Beclere
Clamart, , France
Krankenhaus Bruneck
Bruneck (BZ), , Italy
Demetra S.R.L
Florence, , Italy
Futura Diagnostica medica PMA SRL
Florence, , Italy
USL Toscana Nordovest
Viareggio, , Italy
Oslo University Hospital
Oslo, , Norway
Sykehuset Telemark HF Fertilitetsavdeliningen Sor
Skien, , Norway
St. Olavs Hospital Hf, Universitetssykehuset i Trondheim
Trodheim, , Norway
Centro Hospitalar e Universitario de Coimbra
Coimbra, , Portugal
Hospital de Cruces
Barakaldo, , Spain
Nephrology Service Fundacion Puigvert
Barcelona, , Spain
Hospital Universitario Virgen de las Nieves
Granada, , Spain
Hosp Univ de Canarias
Santa Cruz de Tenerife, , Spain
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Trial Awareness and Transparency website
Medical Information Location Map - Med Info Contacts
Other Identifiers
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MS200497_0006
Identifier Type: -
Identifier Source: org_study_id