Embryo Assessment Utilizing Timelapse Imaging in Conjunction With Preimplantation Genetic Testing for Aneuploidy With Next Generation Sequencing
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Patient age
研究概览
简要总结
The goal of this observational study is to discern if there is a relationship between timelapse imagery of human oocytes/embryos and PGT results.
Embryos of patients that are undergoing PGT will be placed into a timelapse incubator. The data obtained by the timelapse incubator will be used in conjunction with the PGT data to determine any relationships.
详细描述
Timelapse imagery (TLI) is a multifaceted technology being utilized within the in vitro fertilization (IVF) space. With this technology it is possible to have a live, continuous video of embryo development from fertilization to implantation. During this live evaluation multiple datapoints can be extrapolated and used to determine embryo viability. Another technology used in the IVF space is preimplantation genetic testing for aneuploidy (PGT-A). With this technology, individual cells from the embryo are removed, amplified, and the chromosomal content of the cells is analyzed by next generation sequencing (NGS)-based technology, allowing the chromosomal content of the embryos to be determined prior to embryo transfer.
To date, no one has combined the data from both tools to try to advance the IVF field.
Gattaca Genomics is proposing utilizing the data obtained from TLI, in conjunction with the data obtained from PGT-A, to create a computer model that can accurately predict which embryos will lead to a successful outcome during IVF.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all patients undergoing IVF with PGT
排除标准
- •patients undergoing IVF and not electing for PGT
研究组 & 干预措施
Infertile patients
Infertile patients undergoing IVF with PGT.
干预措施: Timelapse incubation and PGT (Diagnostic Test)
结局指标
主要结局
Patient age
时间窗: 0 days
Patient age
Days of stimulation
时间窗: 0-15 days
the number of days the patient underwent stimulation for IVF
Time to first cleavage
时间窗: 24 hours
time of embryo to undergo first cleavage
Time to blastulation
时间窗: 5-7 days
time of embryo to form a blastocoel
Pregnancy
时间窗: 2 weeks after transfer
initial bhCG levels
Fertilization morphology
时间窗: 24 hours
the morphological appearance of the pronuclei
Embryo morphology
时间窗: 2-7 days
the morphological appearance of the embryos
Partner age
时间窗: 0 days
Partner age
Partner diagnosis
时间窗: 0 days
Partner diagnosis
Metabolomics of culture media
时间窗: 7 days
measurement of the spent culture media for amino acids, enzymes, and metabolites
AMH
时间窗: 0 days
antimullerian hormone level in female's blood
Dosage of stimulation meds
时间窗: 0-15 days
the amount of stimulation meds the patient took during IVF treatment
Patient diagnosis
时间窗: 0 days
Number of patients with each specific diagnosis, including low ovarian reserve, PCOS, primary infertility, secondary infertility, endometrosis, and unknown infertility.
implantation
时间窗: 4 weeks post transfer
Number of patients that develope a sac within the uterus post transfer
fetal cardiac heartbeat
时间窗: 6 weeks
Number of patients that develop a fetal cardiac heartbeat after transfer
livebirth
时间窗: approximately 9 months after transfer
Number of patients that have a livebirth of an infant after IVF
次要结局
未报告次要终点