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临床试验/NCT04493788
NCT04493788Unknown不适用

Novel Molecular Characterization of Oocytes and Cumulus Cells From Women With Polycystic Ovarian Syndrome (PCOS) Phenotype A

Universitair Ziekenhuis Brussel0 个研究点目标入组 30 人开始时间: 2020年7月最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
主要终点
Gene expression profiles in oocytes and cumulus cells

研究概览

简要总结

Polycystic ovary syndrome (PCOS) is a common disorder in women of reproductive age that is characterized by elevated androgen levels, ovulatory dysfunction and polycystic ovarian morphology (PCOM). Moreover, has been associated to insulin resistance, obesity, type 2 diabetes and infertility.

Women with PCOS are a heterogeneous group, and specific PCOS phenotype could have a substantial impact on oocyte quality and molecular profile. Regarding the Rotterdam criteria for PCOS, four different phenotypes of the syndrome are defined (A, B, C, D). Phenotypic group A is the most frequent and severe subtype of PCOS. It is described that patients with so-called phenotype A exhibit a significantly increased risk of pregnancy complications compared to women with more favorable PCOS phenotypes. Specifically, this clinical-laboratory study will focus on the molecular characterization of PCOS phenotype A.

Epigenetic are external modifications to DNA that affect how cells "read" genes. These external modifications have garnered attention in the pathogenesis of PCOS since epigenetics changes have been reported in various organs in women with the condition. However, remains unknown whether these alterations are also found in the egg and in its surrounding cells.

Further research is needed to understand the PCOS disorder and to design treatments that can ameliorate the symptoms of the disease. In particular, this project aims to generate the molecular profiles of PCOS phenotype A eggs and surrounding cells and compare them with the ones obtained from and healthy controls. This approach involves the aspiration of immature eggs without hormonal stimulation or with stimulation of only a few days.

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 37 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • women between the ages of 18 and 37
  • biochemical hyperandrogenism
  • ovulatory dysfunction
  • polycystic ovaries)
  • normal andro-gen levels
  • normal ovarian function
  • normal ovarian morphology
  • BMI < 29.

排除标准

  • congenital adrenal hyperplasia
  • Cushing's syndrome
  • androgenic-secreting tumor
  • high (>grade 2) grade endometriosis
  • major uterine or ovarian abnormalities
  • pregnant women
  • volunteers with metabolic syndrome

结局指标

主要结局

Gene expression profiles in oocytes and cumulus cells

时间窗: This information is expected to be generated in 24 months

Another primary outcome measure of this project will be the generation of gene expression profile of PCOS oocytes and paired cumulus cells using single-cell and low-cell parallel sequencing, respectively.

DNA methylation profiles in oocytes and cumulus cells

时间窗: This information is expected to be generated in 24 months

On of the primary outcome measure of this project will be the generation of DNA methylation profile of PCOS oocytes and paired cumulus cells using single-cell and low-cell parallel sequencing, respectively.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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