TICON-Day 3, Time Lapse Versus Conventional Method in Day 3 Embryo Culture and Assessment

NCT03164551 | Terminated Phase 4 Results

• 1 other identifier: MS200497_0006
• Study Type: interventional
• Target: 408
• Locations: 7 countries
• Sites: 17

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.

Conditions

Infertility

Keywords

GERI+; TICON; EEVA; Embryo culture; In Vitro Fertilization; Intracytoplasmic Sperm Injection

Outcome Measures

Primary Outcomes (1)

• Clinical Pregnancy Rate With Positive Fetal Heart Beat (FHB)

  Clinical Pregnancy was defined as the pregnancy diagnosed by ultrasonographic or clinical documentation of at least one fetus with heart beat in gestational week 6 to 8. Clinical pregnancy rate with positive FHB was measured as the number of participants with FHB positive clinical pregnancy divided by number of participants with embryo transfer (ET) multiplied by 100. Here, data used for analysis was based on Merck Global Medical Affairs (GMA) interpretation.

  Gestation Weeks 6 to 8

Secondary Outcomes (9)

• Utilizable Embryos Rate

  Day 3 of embryo culture

• Good Quality Embryos Rate

  Day 3 of embryo culture

• Non-viable Embryos Rate

  Days 1 to 3 of embryo culture

• Implantation Rate (IR) With Positive Fetal Heart Beat

  Gestational Weeks 6 to 8

• Biochemical Pregnancy Rate

  From Day 12 of Gestational up to Week 8

Study Arms (2)

GERI+ Incubator

ACTIVE COMPARATOR

Device: GERI+ incubator

Conventional incubator

OTHER

Device: Conventional incubator

Interventions

GERI+ incubator DEVICE

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.

GERI+ Incubator

Conventional incubator DEVICE

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.

Conventional incubator

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: lead

Study Sites (17)

Cambrian Wellness Centre

Calgary, T3B 4N2, Canada

Location

Regional Fertility Program

Calgary, Canada

Location

Skive Fertility clinic

Skive, 7800, Denmark

Location

Fertility Clinic Skive Regional Hospital

Skive, Denmark

Location

Hopital Antoine Beclere

Clamart, 92140, France

Location

Krankenhaus Bruneck

Bruneck (BZ), I-39031, Italy

Location

Demetra S.R.L

Florence, 50141, Italy

Location

Futura Diagnostica medica PMA SRL

Florence, SO129, Italy

Location

USL Toscana Nordovest

Viareggio, 55043, Italy

Location

Oslo University Hospital

Oslo, Norway

Location

Sykehuset Telemark HF Fertilitetsavdeliningen Sor

Skien, 3710, Norway

Location

St. Olavs Hospital Hf, Universitetssykehuset i Trondheim

Trodheim, N-7006, Norway

Location

Centro Hospitalar e Universitario de Coimbra

Coimbra, 3000-075, Portugal

Location

Hospital de Cruces

Barakaldo, 48903, Spain

Location

Nephrology Service Fundacion Puigvert

Barcelona, 8025, Spain

Location

Hospital Universitario Virgen de las Nieves

Granada, Spain

Location

Hosp Univ de Canarias

Santa Cruz de Tenerife, Spain

Location

Related Links

• Trial Awareness and Transparency website
• Medical Information Location Map - Med Info Contacts

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Results Point of Contact

• Title: Communication Center
• Organization: Merck KGaA, Darmstadt, Germany

service@emdgroup.com

+49-6151-72-5200

Study Officials

• Medical Responsible

  Merck KGaA, Darmstadt, Germany

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2017
• First Posted: May 23, 2017
• Study Start: April 16, 2018
• Primary Completion: November 20, 2019
• Study Completion: November 20, 2019
• Last Updated: December 2, 2020
• Results First Posted: December 2, 2020

Record last verified: 2020-11

Locations

IT (4); ES (4); NO (3); CA (2); FR (1); PT (1); DK (2)