Urinary Concentration of Phthalate Metabolites in Women With and Without Endometriosis: a Case-control Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 440
- 试验地点
- 1
- 主要终点
- Evaluate urinary concentration of phthalates
研究概览
简要总结
Exposure to endocrine-disrupting chemicals can considerably affect female reproductive system. Exposure can occur in living environments and in specific workplaces in which these substances are produced or used. Among endocrinedisrupting chemicals, phthalates, dialkyl esters or alkyl aryl esters of orthophthalic acid (1,2-dicarboxylic acid) represent a group of structurally similar molecules, widely used in industry since 1930 in numerous manufacture processes, mainly as a plasticizer.
These substances present dangerous characteristics, particularly associated with reproductive toxicity, and their xenoestrogenicity led some authors to evaluate a possible involvement in the aetiology of endometriosis.
In this proposed study the investigators aim to clarify a potential association between endometriosis and phthalates exposure.
Women with a diagnosis of endometriosis will be recruited as "cases" while women without endometriosis as "controls". An "ad hoc" questionnaire will be administered to the patient to collect the necessary information on the characteristics of endometriosis as well as their lifestyle and work habits.
The biological monitoring will be carried out measuring the urinary levels of phthalate metabolites. In order to produce reliable data and to reduce the possible contamination caused by the contact with plastic materials, samples will be analyzed by High Performance Liquid Chromatography/Tandem Mass Spectrometry (HPLC-MS/MS).
A statistical elaboration of the data will clarify possible identifiable risk factors and associations with specific clinical situations.
The investigators expect that women with endometriosis may present higher levels of phthalates compared with women without the disease. In particular, the investigators hypothesize that women with the most severe form of the disease [i.e. deep infiltrating endometriosis (DIE)] may present the highest levels. These study findings will provide valuable suggestions for developing effective strategies to prevent endometriosis.
详细描述
Exposure to phthalates can considerably affect female reproductive system. Recent evidence suggests that one of the diseases related to the high concentration of phthalate metabolites in biological fluids might be endometriosis.
This case-control study aims to evaluate the relationship between endometriosis and phthalates exposure through biomarkers analysis in urine. The investigators hypothesize that women with endometriosis, particularly those with deep infiltrating forms (i.e. the most severe form of the disease), will show higher urinary phthalate metabolites compared to women with ovarian/peritoneal forms and those without endometriosis. When deep lesions and ovarian lesions co-existed, the woman will be included in the deep infiltrating subgroup, as the former lesions are considered more severe than the latter ones.
The identification of a possible environmental risk, such as the exposure to phthalates, could allow the implementation of preventive measures aimed at reducing the exposure to such contaminants. Moreover, clinical data obtained may contribute to a better understanding of the etiology and the pathophysiology of endometriosis.
The main objective of the present study is to evaluate the levels of exposure to phthalates of a female population with endometriosis and to understand if it differs significantly from a population of women without the disease.
Identifying a possible relationship between urinary phthalates metabolite concentrations and the risk of endometriosis could represent a valuable tool for implementing specific preventive measures, especially in the workplace.
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Endometriosis group are women aged 18-45 with a diagnosis of endometriosis who report having lived in the past ten years in the Lombardy area.
- •Control group are women aged 18-45 who do not have endometriosis who report having lived in the past ten years in the Lombardy area.
排除标准
- •Pregnancy
- •Uterine fibroids, gynecological cancers
- •Renal, hepatic, cardiovascolar disease, diabetes or high blood pressure
结局指标
主要结局
Evaluate urinary concentration of phthalates
时间窗: 24 months
The main objective of the present study is to evaluate the levels of exposure to phthalates of a female population with endometriosis and to understand if it differs significantly from a population of women without the disease. Identifying a possible relationship between urinary phthalates metabolite concentrations and the risk of endometriosis could represent a valuable tool for implementing specific preventive measures, especially in the workplace
次要结局
- Variations in urinary concentration phthalate metabolite levels in women with different symptoms of the disease(24 months)
- Identify possible routes of exposure in everyday life and/or working environments(24 months)
- Variations in urinary concentration phthalate metabolite levels in women with different phenotypes of the disease(24 months)
- Identify work context in which health risks for women could be highly than for men(24 months)
研究者
Direzione Ginecologia
Principal Investigator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico