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临床试验/NCT03241329
NCT03241329已完成不适用

Characterization of Normal and Pathological Oocyte Cohort After Controlled Ovarian Stimulation: Example of Endometriosis

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2018年2月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
16
试验地点
1
主要终点
Metabolic profile

研究概览

简要总结

The aim of this study is to evaluate the impact of endometriosis on folliculogenesis and oocyte quality. To do so, a metabolomic approach will be conducted in order to analyze the follicular fluid. This evaluation will be completed by a transcriptomic analysis from the cumulus cells of the oocyte.

The normal and pathological oocyte cohort after controlled ovarian stimulation will be also characterized by identifying the oocyte leading to live birth.

详细描述

Endometriosis pathophysiology remains under controversy. Among the various issues raised, that of his involvement in an implantation failure related to an alteration of the endometrium is advanced by some authors. For others, infertility would be linked to an alteration of the oocyte quality responsible for embryonic development impairment leading to a lack of implantation. Several research groups have also mentioned the association of the two mechanisms.

The oocyte quality evaluation is also subject to controversy. Indeed, its morphological approach remains the most commonly used in routine at the IVF laboratory. However, this tool remains limited and to date, no correlation between oocyte morphology and ART outcomes have been established. In this context, there is a real need to use functional approaches such as genomics, transcriptomics, proteomics and metabolomics. However, the clinical validation and application of these functional tools have to be evaluated from a human pathology model such as endometriosis.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Group 1: case
  • a. Womens with endometriosis i. Deep endometriosis without ovarian localisation ii. Deep endometriosis associated with ovarian localisation iii. Isolated ovarian localisation b. Male partner with normal sperm parameters Group 2 : control
  • Womens with isolated tubal factor
  • Male partner with normal sperm parameters

排除标准

  • Other pathologies responsible for female infertility
  • Altered sperm parameters
  • Male or female viral risk
  • Oocyte or sperm donation

结局指标

主要结局

Metabolic profile

时间窗: 2 years

Identification of a possible particular metabolomic profile from the follicular fluid in endometriosis

Transcriptomic profile

时间窗: 2 years

Identification of a possible particular transcriptomic profile from the cumulus cells in endometriosis

次要结局

  • Oocyte characterization(2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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Endometriosis Impact on Oocyte Quality | 临床试验