Amino Acid Profiling of Spent Culture Medium to Retrospectively Determine Individual Embryo Selection Criteria for Improved Clinical IVF Outcome
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Amino acid profile
研究概览
简要总结
The purpose of this study is to develop an algorithm for embryo selection based on amino acid profiling (AAP) of spent culture medium. Development of the algorithm will be based on the ongoing implantation rate of the individual embryos transferred. As evaluated by ultrasound scan in gestational week 7.
详细描述
IVF/ICSI treatment has permitted many thousands of couples to conceive worldwide yet is limited by low success rates (in UK, approx. 25% live birth rate/treatment cycle for women up to 42 years of age; HFEA Annual Report, 2006) and a confounding high multiple birth rate (23%) due to the transfer of more than a single pre-implantation embryo. Multiple births are associated with prematurity, increased neonatal and maternal mortality and child handicap as well as being a major burden for health care systems. These problems have been highlighted in the data published by the HFEA (2009), which has called for "a professionally-led, coordinated national strategy to reduce the number of multiple births". This challenge could be met if single embryos of known developmental competence could be selected for transfer, thereby making the embryo selection process even more crucial. However, current non-invasive embryo selection criteria using light microscope analysis have limited predictive value for ongoing pregnancy.
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 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Minimum 4 x 2PN´s on Day 1 post insemination
- •Subjects undergoing IVF or ICSI treatment with a maximum of 2 embryos transferred
- •Both partners should be capable of understanding the study to which they are consenting
- •Females > 18 and ≤ 40 years of age
- •Regular menstrual cycle 21-35 days (both inclusive)
- •Women treated with a standard drug protocol
排除标准
- •The couple has previously participated in the DK005 study
- •Use of assisted hatching
- •Indication for TESA or PESA
- •Any medical conditions or genetic disorders prohibiting IVF/ICSI or interfering with the interpretation of results of the study (including pre- implantation genetic diagnostics).
- •Use of any investigational drug within 30 days before oocyte retrieval
- •Any severe chronic disease of relevance for reproductive function.
- •Oocyte donation patients (donor or recipient).
结局指标
主要结局
Amino acid profile
时间窗: After 24 hours of culture
Amino acid profiling (AAP) will be performed of spent culture medium from individually cultured embryos. AAP results will be correlated to the ongoing implantation rate week 7 as well as morphological embryo development parametres.
次要结局
- Ongoing clinical pregnancy rate(Gestational week 7)