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

Infertility Clinical Trial

— TICON  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03164551
• Other study ID #: MS200497_0006
• Status: Terminated
• Phase: Phase 4
• Start date: April 16, 2018
• Est. completion date: November 20, 2019

Study information

• Verified date: November 2020
• Source: Merck KGaA, Darmstadt, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 408
• Est. completion date: November 20, 2019
• Est. primary completion date: November 20, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Canada	Cambrian Wellness Centre	Calgary
Canada	Regional Fertility Program	Calgary
Denmark	Fertility Clinic Skive Regional Hospital	Skive
Denmark	Skive Fertility clinic	Skive
France	Hopital Antoine Beclere	Clamart
Italy	Krankenhaus Bruneck	Bruneck (BZ)
Italy	Demetra S.R.L	Firenze
Italy	Futura Diagnostica medica PMA SRL	Firenze
Italy	USL Toscana Nordovest	Viareggio
Norway	Oslo University Hospital	Oslo
Norway	Sykehuset Telemark HF Fertilitetsavdeliningen Sor	Skien
Norway	St. Olavs Hospital Hf, Universitetssykehuset i Trondheim	Trodheim
Portugal	Centro Hospitalar e Universitario de Coimbra	Coimbra
Spain	Hospital de Cruces	Baracaldo
Spain	Nephrology Service Fundacion Puigvert	Barcelona
Spain	Hospital Universitario Virgen de las Nieves	Granada
Spain	Hosp Univ de Canarias	Santa Cruz de Tenerife

Sponsors (1)

Lead Sponsor	Collaborator
Merck KGaA, Darmstadt, Germany

Countries where clinical trial is conducted

Canada,  Denmark,  France,  Italy,  Norway,  Portugal,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Utilizable Embryos Rate	Utilizable embryos rate is defined as the number of transferred and cryopreserved embryos divided by the number embryos stage zygotes per participant multiply by 100. Here, data used for analysis was based on Merck GMA interpretation.	Day 3 of embryo culture
Secondary	Good Quality Embryos Rate	Good Quality Embryos is defined embryos with 7 or more blastomeres, less than (<) 25 % fragmentation, size and symmetry of blastomeres appropriate to the cell number, and no evidence of multinucleation, based on the morphology on Day 3 of embryo culture. Good quality embryos rate was defined as the number of good quality embryos divided by the number of embryos per participant multiplied by 100. Here, data used for analysis was based on Merck GMA interpretation.	Day 3 of embryo culture
Secondary	Non-viable Embryos Rate	Non-viable Embryos is defined as the embryos in which development has been arrested for at least 24 hour or in which all the cells have degenerated or lysed. Non-viable embryos rate was defined as the number of non-viable embryos divided by the number of embryos per participant multiplied by 100. Here, data used for analysis was based on Merck GMA interpretation.	Days 1 to 3 of embryo culture
Secondary	Implantation Rate (IR) With Positive Fetal Heart Beat	A successful implantation is defined as the presence of one gestational sac with fetal heart beat (FHB) under ultrasonography at gestational weeks 6-8. Implantation rate (IR) was defined as the number of intrauterine gestational sacs with positive FHB under ultrasound scans at gestational weeks 6-8 divided by the total number of embryos transferred (ET) multiplied by 100. Here, data used for analysis was based on Merck GMA interpretation.	Gestational Weeks 6 to 8
Secondary	Biochemical Pregnancy Rate	Biochemical Pregnancy defined as a pregnancy diagnosed only by the detection of Human Chorionic Gonadotropin (hCG) in serum or urine and that does not develop into a clinical pregnancy. Biochemical pregnancy rate was defined as the number of participants with biochemical pregnancy divided by the number of participants with embryo transfer (ET) multiplied by 100. Here, data used for analysis was based on Merck GMA interpretation.	From Day 12 of Gestational up to Week 8
Secondary	Ongoing Pregnancy Rate	Ongoing pregnancy is defined as the presence of viable fetuses identified by ultrasonography at gestational weeks 10-12. Ongoing pregnancy rate is defined as the number of participants with ongoing pregnancy divided by the number of participants with embryo transfer (ET) multiplied by 100. Here, data used for analysis was based on Merck GMA interpretation.	Gestational Weeks 10 to 12
Secondary	Multiple Pregnancy Rate	Multiple pregnancy is defined as a pregnancy with more than one fetus. It is identified by ultrasonography at gestational weeks 10-12. Multiple pregnancy rate was defined as the number of participants with multiple pregnancy divided by the number of participants with ongoing pregnancy multiplied by 100. Here, data used for analysis was based on Merck GMA interpretation.	Gestational Weeks 10 to 12
Secondary	Ectopic Pregnancy Rate	Ectopic pregnancy is defined as a pregnancy in which implantation takes place outside the uterine cavity. It is identified by ultrasonography at weeks 6-8. Ectopic Pregnancy Rate was defined as the number of participants with ectopic pregnancy divided by the number of participants with embryo transfer (ET) multiplied by 100. Here, data used for analysis was based on Merck GMA interpretation.	Gestational Weeks 6 to 8
Secondary	Spontaneous Miscarriage Rate	Spontaneous miscarriage (SM) is the spontaneous loss of a clinical pregnancy before 20 completed weeks of gestational age (18 weeks after fertilization). In this study, the spontaneous miscarriage was tracked up to 10-12 weeks of gestational age. Spontaneous miscarriage rate was defined as the number of participants with spontaneous miscarriage divided by the number of participants with clinical pregnancy multiplied by 100. Here, data used for analysis was based on Merck GMA interpretation.	Gestational Weeks 10 to 12

External Links

•   Trial Awareness and Transparency website