Non-selection Trial Comparing Metabolomics to PGT-A Embryo Selection Using Vitrolife G-TL Media
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 205
- 试验地点
- 2
- 主要终点
- Negative predictive value (NPV) and positive predictive value (PPV) for MEI vs. expected implantation based solely on morphology.
研究概览
简要总结
In this study, study investigators will collect embryo culture media on day 5 of vitro fertilization (IVF) culture, prior to vitrification and embryo transfer for testing via Metabolomic screening. Metabolomics is a new, non-invasive method of embryo selection which involves testing discarded embryo culture media for analytes secreted by the developing embryo. These analytes can be used to determine the implantation potential, and ploidy, of the embryo.
详细描述
Patients will undergo a routine IVF cycle. This will include ovarian stimulation, egg retrieval and fertilization of oocytes through intracytoplasmic sperm injection (ICSI). All fertilized oocytes will be cultured up to blastocyst for five to six days.
Spent media will be collected on day 5-6 for all embryos reaching blastocyst on day 5, and on day 6 for those reaching blastocyst on day 6. The spent culture media will be sent to a lab for metabolomic analysis.
For the embryo transfer, the best morphology blastocyst will be selected for transfer by the New Hope embryologist.
Approximately 8-11 days after the embryo transfer, the patient will return to the clinic for a serum pregnancy test. Should the test be negative, they will be closed out of the study. Should the test be positive, they will continue to be monitored.
The patient will return to the clinic at approximately 8 weeks after embryo transfer for a serum pregnancy test, and an ultrasound to detect fetal heartbeat. The outcome will be documented and the patient closed out of the study at this time.
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 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women of any age, 25% of patients <35 years, 25% of patients 35-37, 25% of patients 38-40, and 25% of patients >40 years.
- •Signed Subject Consent Form. No inferior limit on number of eggs
排除标准
- •At the time of initial visit:
- •Require or request PGT of any kind
- •Low ovarian reserve defined as follicle stimulating hormone (FSH) >10 IU/L on day 2-4 of a prior menstrual cycle and anti-mullerian hormone (AMH) <15 pmol/L (or <2 ng/ml) within prior 12 months of cycle start
- •At the time of embryo selection:
- •Patients without at least one embryo to transfer.
结局指标
主要结局
Negative predictive value (NPV) and positive predictive value (PPV) for MEI vs. expected implantation based solely on morphology.
时间窗: Approximately 4-5 months, inclusive of IVF cycle, embryo transfer and monitoring up to eight weeks
PPV (MEI high potential implanting / Total implanting), NPV (MEI low potential implanting / Total not implanting)
次要结局
未报告次要终点
研究者
Dr. Jose Horcajadas
Principal Investigator
Overture Life