An Observational Study of Artificial Intelligence-Assisted Blastocyst Morphokinetic Analysis Using Short-Duration Video and Its Association With Pregnancy Outcomes
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
研究概览
简要总结
The goal of this observational study is to learn if embryo characteristics obtained via the recording of real-time embryo activity via 30-seconds video capture (e.g.: Embryo Morphokinetics) can correlate with known embryo outcome in patients receiving In-Vitro Fertilization Treatment (IVF).
Current Embryo morphology is performed with direct observation of embryo characteristics under the microscope. The observer will follow embryo grading standards based on embryo symmetry, development stage and growth pattern based on day of culture, presence of defined embryo characteristics with definition of viability to transfer into the uterus, cryopreserve for future use or discard.
Today, the final embryo outcome can be correlated with the subjective embryo grading performed by the embryologist to evaluate how precise is the viability assessment of embryo characteristics and potential.
This observational study attempts to create enough data to evaluate if real-time embryo morphokinetics can correlate with known outcomes. Patients participating in this study will not obtain any benefit from the recording of their embryos. They'll continue with their treatment according to the medical provider decision. Embryos will be selected using standard of care practice including:
Transfer into the uterus. Cryopreservation. Biopsy for pre-implantation genetic testing and cryopreservation. Discard. The data obtained from this study will be analyzed to generate hypothesis and potentially design a prospective study where this tool can be used to aid in the embryo grading and selection process in comparison with standard of care.
The study includes patients undergoing Assisted Reproductive Technologies (ART) including IVF, Intracytoplasmic Sperm Injection (ICSI), Frozen-Thawed Embryo Transfer including or not Embryos previously analyzed genetically. This includes embryos already defined as viable (genetically normal) or embryos to be discarded (genetically abnormal).
What is Embryo Morphokinetics? Embryos are in constant movement with cellular activity invisible to the naked eye. Capturing a real-time video can convert that cellular movement and activity into pixels. Those pixels can be followed, and certain patterns can be observed and created. With the use of Artificial Intelligence (AI) those patterns can be identified, labelled, and analyzed to potentially be correlated with embryo outcome. It has been demonstrated, in the animal field, that embryos with certain morphokinetics patterns do not implant inside the uterus therefore not achieving a pregnancy. Also, embryos with high activity may be associated with genetic abnormality.
In this study the following comparisons will be performed.
Embryo Morphokinetics at the Blastocyst stage including:
Blastocyst morphokinetics before cryopreservation and after thawing. Blastocyst morphokinetics before and after trophectoderm biopsy. Blastocyst morphokinetics in euploid embryos before transfer. Blastocyst morphokinetics in aneuploid embryos before discard.
- Primary hypothesis: Blastocyst morphokinetics correlate with Pregnancy outcome
- Secondary hypothesis: Blastocyst morphokinetics correlates with embryo recovery after thawing and after biopsy.
- Tertiary hypothesis: Blastocyst morphokinetics correlates with know genetic diagnosis (euploid or aneuploid)
详细描述
BACKGROUND Assisted reproductive technologies encompass a range of medical and laboratory procedures designed to facilitate fertilization and embryo implantation when natural conception is not possible or practical. Despite continuous technological progress, successful pregnancy following embryo transfer remains uncertain. Registry data demonstrate that implantation and live birth rates remain moderate rather than guaranteed outcomes. For example, data reported by the Society for Assisted Reproductive Technology (SART) demonstrated an overall clinical pregnancy rate of approximately 45.7% per transfer in the United States in 2020, while European registry data published by the European Society of Human Reproduction and Embryology (ESHRE) reported pregnancy rates of approximately 34% per embryo transfer cycle.
Given these limitations, improving embryo selection represents one of the most important opportunities to enhance ART efficiency. Identification of embryos with the highest developmental competence could reduce the number of treatment cycles required to achieve pregnancy, minimize patient exposure to repeated procedures, and decrease overall societal and healthcare expenditures. Consequently, substantial research efforts have focused on developing objective biomarkers capable of predicting embryo implantation potential.
Currently, embryo selection in most IVF laboratories relies predominantly on morphological assessment at the blastocyst stage. Key parameters include blastocoel expansion, trophectoderm cell appearance, and inner cell mass organization, as described in standardized grading systems such as the Gardner classification.
Although morphology correlates with implantation potential, assessment depends on visual interpretation by trained embryologists and therefore remains inherently subjective and operator-dependent, limiting reproducibility across centers.
The present observational study is designed to generate clinical and technical performance data necessary to support hypothesis development and future regulatory evaluation of an embryo image-assessment technology. Clinical performance evaluation must demonstrate reasonable assurance of safety and effectiveness in predicting embryo developmental potential. Device performance will therefore be evaluated through measures including classification accuracy, sensitivity, specificity, positive predictive value, and negative predictive value at both embryo and patient levels.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Signed Inform Consent
- •Ages between 18 and 45 years
- •Patients using own or donated eggs
- •Patients undergoing assisted reproduction procedures (ICSI with Embryo Transfer, Frozen Embryo Transfers with or without PGT-A receiving a single embryo transfer.
- •Patients with at least one embryo at the blastocyst stage on day 5, day 6 or day 7 of embryo development.
- •Patients using a surrogate carrier for the embryo transfer procedure.
- •Patients with Abnormal Embryos after PGT-A to be discarded.
- •Patients with Euploid Embryos after PGT-A to be discarded
排除标准
- •Absence of viable embryos at the blastocyst stage.
- •Any uterine abnormalities that could affect embryo implantation.