跳至主要内容
临床试验/NCT06094439
NCT06094439招募中不适用

Targeted Metabolomics of Spent Embryo Culture Medium

gyn-medicum Göttingen1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
20
试验地点
1
主要终点
Metabolomics profiles of good vs. Metabolomics profiles of poor quality embryos

研究概览

简要总结

More than 8 million babies have been born through in vitro fertilization (IVF). Non-invasive observation of embryos in vitro to better understand their development is becoming increasingly important. Morphology has been used as standard from the beginning, but has the disadvantage of subjectivity. Now the emphasis in basic and clinical research is on developing rapid, quantitative, non-invasive tests. Hence comes the idea of metabolic profiling of spent embryo culture medium (SECM) as a biomarker. This could be useful for understanding and improving the nutritional environment of oocytes and embryos. The goal of our study is to determine metabolic profiles of the SECM in combination with morphological assessments to better understand the nutritional requirements of the embryo. The goal would be to optimize media specifically, depending on patient and embryo characteristics ("personalized medicine") ("the embryo in vitro as patient").

详细描述

Following successful fertilization (day 1), each embryo will be cultured for 5-6 days (day 5-6) to form the blastocyst. Then, morphological evaluation will be performed by an expert embryologist to confirm poor and good embryo quality. At the end of the culture, 50 µl of SECM will be collected from each embryo and stored for metabolomics analysis. Samples including medium only and no embryos will be used as controls. The metabolome will be characterized in SECM samples using the respective assay targeted kit.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
35 Years 至 46 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Available spent embryo culture medium (SECM) samples with Informed consent

排除标准

  • 未提供

结局指标

主要结局

Metabolomics profiles of good vs. Metabolomics profiles of poor quality embryos

时间窗: 24 months

The metabolome will be characterized in SECM samples of good and poor quality embryos using the respective assay kit. This method needs to be developed and analyses are planned in cooperation with the metabolomics core facility; the targeted metabolomics approach using the MxP® Quant 500 kit assay (BIOCRATES Life Sciences AG, Innsbruck, Austria) will be used. The kit plates are used for the quantification of amino acids, acylcarnitines, sphingomyelins, phosphatidylcholines, hexoses, and biogenic amines in SECM of good and poor quality embryos. Results of metabolic set enrichment analysis (MSEA) and metabolic pathway analysis (MetPA) will be used as the final results to compare the metabolite profiles of good and poor quality embryos .

次要结局

未报告次要终点

研究者

发起方
gyn-medicum Göttingen
申办方类型
Other
责任方
Sponsor

研究点 (1)

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