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A method for evaluating endometrial receptivity of patient and kit for performing method

A technology of endometrium receptivity, which is applied in biochemical equipment and methods, microbial measurement/testing, etc., can solve problems such as the limitation of morphological standards and unsuccessful endometrial receptivity

Pending Publication Date: 2020-12-29
IGENOMIX SL
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, morphological criteria have significant limitations for predicting endometrial receptivity, as demonstrated in randomized studies
Endometrial receptivity has also been unsuccessfully investigated at the single-molecule and biochemical levels

Method used

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  • A method for evaluating endometrial receptivity of patient and kit for performing method
  • A method for evaluating endometrial receptivity of patient and kit for performing method
  • A method for evaluating endometrial receptivity of patient and kit for performing method

Examples

Experimental program
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Embodiment

[0177] The following example describes the design of a new ERA NGS predictor tool generated from an expanded dataset of diagnostic and clinical information.

[0178] overview

[0179] This example describes the design and performance of the NGS-predictor tool. This study included the development of NGS predictors and clinical follow-up to validate their diagnostic accuracy after pET. NGS predictors were developed by sequencing 411 endometrial biopsies previously diagnosed by array. Then, 1432 endometrial biopsies (716 patients with two endometrial samples each) were used for predictive analysis. Clinical follow-up of NGS predictors was performed in 261 patients collected from 5 different clinics. These clinical outcomes were compared to previously known outcomes using the ERA array. Endometrial biopsies were collected using a pipelle scraper during the expected WOI (window of implantation) in a natural cycle (at LH+7) or a hormone replacement therapy cycle (at P+5). RNA...

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Abstract

The invention provides a method for evaluating endometrial receptivity of a patient and a kit for performing the method. According to the invention, the human endometrial receptivity functional statusis determined by using RNA or DNA sequencing (e.g., by NGS (next generation sequencing)) of a living tissue examination material from the endometrium, and using the expression of 248 genes related tothe endometrial receptivity status or a specific sub-combination thereof (as shown in Figure 1). Based on analysis, specific computational predictors classify samples according to their expression profiles in corresponding endometrial stages (proliferation stage, pre-receptive stage, early receptive stage, receptive stage, late receptive stage or post-receptive stage). It should be noted that thereceptivity statuses can be assigned through subsequent analysis of expression profiles of a specific gene set by the computational predictors.

Description

technical field [0001] The present specification relates to an improved method for determining the functional state of endometrial receptivity in a human by using the expression of 248 genes related to endometrial receptivity state or specific subcombinations thereof. Background technique [0002] Endometrial factors play an important role in the reproductive process because a receptive endometrium is necessary to allow embryo transfer. The human endometrium is non-receptive during the menstrual cycle, except for a brief, self-limiting period when it reaches a receptive phenotype allowing embryo attachment. This period is called the window of implantation (WOI, window of implantation) and usually opens (starts) 5 days after progesterone exposure. An understanding of this phenotype will provide a better and broader understanding of the reproductive process; to this end, the human endometrium has been extensively studied for biomarkers that can predict this receptive state. ...

Claims

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Application Information

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IPC IPC(8): C12Q1/6876C12Q1/6869
CPCC12Q1/6869C12Q1/6876C12Q2600/158C12Q2600/166C12Q2531/113C12Q2535/122C12Q2545/113C12Q2525/191
Inventor 卡洛斯·安东尼奥·西蒙·瓦列斯莫尼卡·克莱门特·西斯卡
Owner IGENOMIX SL
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