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临床试验/NCT02698488
NCT02698488Unknown不适用

Embryo Selection by Metabolomic Profiling of Embryo Culture Medium With Mass Spectroscopy as an Adjunct to Morphology: a Randomized Controlled Trial

Istanbul University1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2016年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
300
试验地点
1
主要终点
Clinical Pregnancy

研究概览

简要总结

Identification of the embryo with the highest potential to implant and establish an ongoing pregnancy is a primary aim in human assisted reproduction. This task is undertaken every day by embryologists worldwide during the treatment of couples that wish to conceive by IVF. The optimal scenario is the transfer of a single embryo which gives rise to a singleton pregnancy. The current limitations in determination of embryos that have the highest implantation potential probably contribute to the low rates of pregnancy during IVF treatments. Hence, since the beginning of IVF, how to improve embryo selection has been a 'hot research topic.' Morphology has been a very obvious parameter to assess embryos as it provides a chance to evaluate them from the oocyte stage all the way to the blastocysts stage. Hence, in the first era of IVF, there were number of studies that evaluated this parameter and associated morphology with IVF success rates. On the other hand, it has been previously stated that the slight increase in pregnancy rates during IVF treatment is mostly likely a result of better practices in laboratory than morphological evaluation. Due to the limitations of morphological evaluation, several researchers have investigated adjunctive non-invasive approaches for the assessment of the embryo, such as the metabolomic profiling.

Recently mass spectroscopic (MS) approaches have been utilized in limited settings. Samples needed minimal preparation; analytical analysis was rapid and large amounts of data was available. Hence, MS might be a promising approach for metabolomic profiling of embryo culture media.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Double (Participant, Investigator)

入排标准

年龄范围
21 Years 至 38 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •any infertility etiology
  • •good previous response to IVF with ≥1 embryo

排除标准

  • •poor response to IVF previously

研究组 & 干预措施

Embryo Selection by Morphology

Active Comparator

Embryos will be morphologically evaluated according to the number and regularity of blastomeres and fragmentation degree. Only embryo culture media of good quality embryos (embryos with ≥6 cells with no fragmentation) will be included in the study

干预措施: Morphology (Procedure)

Embryo Selection by Morphology

Active Comparator

Embryos will be morphologically evaluated according to the number and regularity of blastomeres and fragmentation degree. Only embryo culture media of good quality embryos (embryos with ≥6 cells with no fragmentation) will be included in the study

干预措施: Morphology and Mass Spectroscopy (Procedure)

Embryo Selection by Morphology and Mass Spectroscopy

Active Comparator

Embryos will be morphologically evaluated according to the number and regularity of blastomeres and fragmentation degree. Only embryo culture media of good quality embryos (embryos with ≥6 cells with no fragmentation) will be included in the study. After dilution, embryo culture media will be analyzed by electrospray ionization quadrupole time-of-flight (ESI-QTOF) MS. The spectra will be collected in the negative ion mode. Abundance of ions in each spectrum will be further analyzed.

干预措施: Morphology (Procedure)

Embryo Selection by Morphology and Mass Spectroscopy

Active Comparator

Embryos will be morphologically evaluated according to the number and regularity of blastomeres and fragmentation degree. Only embryo culture media of good quality embryos (embryos with ≥6 cells with no fragmentation) will be included in the study. After dilution, embryo culture media will be analyzed by electrospray ionization quadrupole time-of-flight (ESI-QTOF) MS. The spectra will be collected in the negative ion mode. Abundance of ions in each spectrum will be further analyzed.

干预措施: Morphology and Mass Spectroscopy (Procedure)

结局指标

主要结局

Clinical Pregnancy

时间窗: 3 months

Clinical pregnancy will be defined as the presence of a fetal heartbeat using vaginal ultrasound at 6 weeks of amenorrhoea.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ercan Bastu

Associate Professor of Obstetrics and Gynecology

Istanbul University

研究点 (1)

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