TICON-Day 3, Time Lapse Versus Conventional Method in Day 3 Embryo Culture and Assessment
- Conditions
- Infertility
- Interventions
- Device: GERI+ incubatorDevice: Conventional incubator
- Registration Number
- NCT03164551
- Lead Sponsor
- Merck KGaA, Darmstadt, Germany
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 408
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description GERI+ Incubator GERI+ incubator - Conventional incubator Conventional incubator -
- Primary Outcome Measures
Name Time Method Clinical Pregnancy Rate With Positive Fetal Heart Beat (FHB) Gestation Weeks 6 to 8 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.
- Secondary Outcome Measures
Name Time Method Good Quality Embryos Rate Day 3 of embryo culture 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.
Non-viable Embryos Rate Days 1 to 3 of embryo culture 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.
Ongoing Pregnancy Rate Gestational Weeks 10 to 12 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.
Utilizable Embryos Rate Day 3 of embryo culture 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.
Biochemical Pregnancy Rate From Day 12 of Gestational up to Week 8 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.
Ectopic Pregnancy Rate Gestational Weeks 6 to 8 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.
Multiple Pregnancy Rate Gestational Weeks 10 to 12 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.
Spontaneous Miscarriage Rate Gestational Weeks 10 to 12 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.
Implantation Rate (IR) With Positive Fetal Heart Beat Gestational Weeks 6 to 8 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.
Trial Locations
- Locations (17)
Demetra S.R.L
š®š¹Firenze, Italy
Skive Fertility clinic
š©š°Skive, Denmark
Fertility Clinic Skive Regional Hospital
š©š°Skive, Denmark
Krankenhaus Bruneck
š®š¹Bruneck (BZ), Italy
Oslo University Hospital
š³š“Oslo, Norway
St. Olavs Hospital Hf, Universitetssykehuset i Trondheim
š³š“Trodheim, Norway
Hospital de Cruces
šŖšøBaracaldo, Spain
Nephrology Service Fundacion Puigvert
šŖšøBarcelona, Spain
Hosp Univ de Canarias
šŖšøSanta Cruz de Tenerife, Spain
Hospital Universitario Virgen de las Nieves
šŖšøGranada, Spain
Centro Hospitalar e Universitario de Coimbra
šµš¹Coimbra, Portugal
Cambrian Wellness Centre
šØš¦Calgary, Canada
Futura Diagnostica medica PMA SRL
š®š¹Firenze, Italy
USL Toscana Nordovest
š®š¹Viareggio, Italy
Sykehuset Telemark HF Fertilitetsavdeliningen Sor
š³š“Skien, Norway
Regional Fertility Program
šØš¦Calgary, Canada
Hopital Antoine Beclere
š«š·Clamart, France