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临床试验/NCT05488236
NCT05488236已完成不适用

Embryo Ploidy Selection by Nuclear Magnetic Resonance: a Fast, Low Cost and Non-invasive Technique to Increase the Success Rate of ART

Instituto Valenciano de Infertilidade de Lisboa2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年4月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
2
主要终点
Comparison of the metabolites present in the culture medium of euploid versus aneuploid embryos.

研究概览

简要总结

This study aims to validate the embryo culture medium analysis by nuclear magnetic resonance spectroscopy, as a faster and less-costly alternative to preimplantation genetic test for aneuploidy which could significantly enhance embryo selection and the success rate of assisted reproductive technologies.

详细描述

Assisted reproductive technologies (ART) refers to treatments used to assist people in achieving a pregnancy. Over the last years, ART have been developed with efforts to deliver a healthy baby. However, the selection of the embryo that most likely results in pregnancy remains a critical step in ART. Currently, this selection is based on morphological assessment of the embryos, but up to 70% of those embryos display an abnormal number of chromosomes. Preimplantation genetic test for aneuploidy (PGT-A) is used to assess the ploidy of embryos, although this is an invasive, expensive and time consuming technique. Alternatively, in order to predict the ploidy of pre-implantation embryos (euploidy vs aneuploidy), we suggest to characterise the metabolic profile of the embryo culture medium by Nuclear Magnetic Resonance (NMR), which is a non-invasive, low cost and fast technique.

The aim of this study is to assess whether, using multivariable analysis to all the collected NMR data, it is possible to identify a differential metabolic pattern between aneuploid and euploid embryos which could improve embryo selection.

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 48 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Age: ≥18 and <49 years old.
  • Body Mass Index ≥18.5 Kg/m2 and <30 Kg/m
  • Planned for in vitro fertilization followed by preimplantation genetic test for aneuploidy.
  • Oocytes retrieval and fertilization by intracytoplasmic sperm injection
  • Six follicles over 14 mm on the day of the triggering. Gonadotropin-releasing hormone antagonist
  • Signed and dated informed consent.

排除标准

  • Previous history of poor ovarian response (<4 oocytes retrieved) with a maximal dose of ovarian stimulation (≥300 IU/day).
  • Presence of a medical condition which is known to affect assisted reproductive technologies outcome (e.g. thyroid dysfunction).
  • Active female smoking.
  • Current use of anti-depressants, anti-psychotics, steroids, antiepileptics or chemotherapy.
  • Those unable to comprehend the investigational nature of the proposed study.

结局指标

主要结局

Comparison of the metabolites present in the culture medium of euploid versus aneuploid embryos.

时间窗: 6 months

The metabolites present in the culture medium of euploid and aneuploid embryos will be identified by NMR and compared to the metabolites present in the culture medium without embryo (control). The metabolic profiles of cultures form euploid and aneuploid embryos will be compared to the metabolic profile of culture medium without embryo.

次要结局

未报告次要终点

研究者

发起方
Instituto Valenciano de Infertilidade de Lisboa
申办方类型
Network
责任方
Sponsor

研究点 (2)

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