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临床试验/NCT05789407
NCT05789407已完成不适用

Is Exposure to Persistent Organic Pollutants Linked to Pelvic Endometriosis?

Jagiellonian University2 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2022年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
46
试验地点
2
主要终点
Accumulation and detection of PAHs in women's visceral fat.

研究概览

简要总结

The health toxicity of polycyclic aromatic hydrocarbons (PAHs), present in air and food, generated during energy production and waste incineration, is well known. PAHs can activate the aryl hydrocarbon receptor, which may interact with classic estrogen receptors and modify estrogen-dependent inflammation in endometriosis. There is no data on the hypothetical role of PAHs in the etiopathogenesis of endometriosis. The aim was to compare PAHs concentrations in visceral fat in women with endometriosis and idiopathic infertility.

详细描述

A prospective cohort tertiary-center study includes women undergoing laparoscopy due to pelvic endometriosis (arm 1) or/and idiopathic infertility (arm 2). A sample of 1 ml of the greater omentum is collected intraoperatively for detection of 16 PAHs, i.e. acenaphthene, acenaphthylene, anthracene, fluoranthene, fluorene, naphthalene, phenanthrene, pyrene, benz[a]anthracene, benzo[b]fluoranthene, benzo[k]fluoranthene, benzo[ghi]perylene, benzo[a]pyrene, chrysene, dibenz[a,h]anthracene, and indeno[1,2,3-cd]pyrene, by gas chromatography-isotope dilution mass spectrometry method. The concentration of selected PAHs in visceral fat in both populations will be compared. The correlation of concentrations of selected PAHs with the occurrence of infertility, pelvic pain syndrome, intensity of pain, peritoneal adhesions and the degree of endometriosis will be checked.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • i) age 18-45, ii) indications for surgical treatment of endometriosis, iii) indications for invasive diagnostics and surgical treatment of idiopathic infertility.

排除标准

  • 未提供

研究组 & 干预措施

endometriosis

Experimental

Women subjected to elective laparoscopy for pelvic endometriosis

干预措施: Detection of PAHs in visceral fat with gas chromatography-isotope dilution mass spectrometry (Diagnostic Test)

idiopathic infertility

Active Comparator

Women subjected to elective laparoscopy for idiopathic infertility

干预措施: Detection of PAHs in visceral fat with gas chromatography-isotope dilution mass spectrometry (Diagnostic Test)

结局指标

主要结局

Accumulation and detection of PAHs in women's visceral fat.

时间窗: up to 6 months

Detection and confirmation of the accumulation of PAHs (acenaphthene, acenaphthylene, anthracene, fluoranthene, fluorene, naphthalene, phenanthrene, pyrene, benz\[a\]anthracene, benzo\[b\]fluoranthene, benzo\[k\]fluoranthene, benzo\[ghi\]perylene, benzo\[a\]pyrene, chrysene, dibenz\[a,h\]anthracene, and indeno\[1,2,3-cd\]pyrene) in human adipose tissue by gas chromatography-isotope dilution mass spectrometry method.

Comparison of concentrations of 16 reference PAHs in women in both study arms.

时间窗: up to 6 months

Comparison of concentrations of 16 PAHs (acenaphthene, acenaphthylene, anthracene, fluoranthene, fluorene, naphthalene, phenanthrene, pyrene, benz\[a\]anthracene, benzo\[b\]fluoranthene, benzo\[k\]fluoranthene, benzo\[ghi\]perylene, benzo\[a\]pyrene, chrysene, dibenz\[a,h\]anthracene, and indeno\[1,2,3-cd\]pyrene) in both study arms using standard statistical methods.

次要结局

  • Evaluation of PAHs concentrations correlation with endometriosis degree(up to 6 months)
  • Evaluation of PAHs concentrations correlation with the presence and severity of peritoneal adhesions(up to 6 months)
  • Evaluation of PAHs concentrations correlation with the intensity of pelvic pain(up to 6 months)

研究者

发起方
Jagiellonian University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Iwona Magdalena Gawron

Ph.D., Principal Investigator

Jagiellonian University

研究点 (2)

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