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
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 408
- 试验地点
- 29
- 主要终点
- Clinical Pregnancy Rate With Positive Fetal Heart Beat (FHB)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Clinical Pregnancy Rate With Positive Fetal Heart Beat (FHB)
时间窗: 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.
次要结局
- Good Quality Embryos Rate(Day 3 of embryo culture)
- Non-viable Embryos Rate(Days 1 to 3 of embryo culture)
- Ongoing Pregnancy Rate(Gestational Weeks 10 to 12)
- Utilizable Embryos Rate(Day 3 of embryo culture)
- Biochemical Pregnancy Rate(From Day 12 of Gestational up to Week 8)
- Ectopic Pregnancy Rate(Gestational Weeks 6 to 8)
- Multiple Pregnancy Rate(Gestational Weeks 10 to 12)
- Spontaneous Miscarriage Rate(Gestational Weeks 10 to 12)
- Implantation Rate (IR) With Positive Fetal Heart Beat(Gestational Weeks 6 to 8)