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Urinary Concentration of Phthalate Metabolites in Women With and Without Endometriosis

NCT05551494 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 440

Last updated 2022-09-22

No results posted yet for this study

Summary

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.

Conditions

  • Endometriosis

Interventions

DIAGNOSTIC_TEST

Urinary sample

At study entry, we will collect urinary samples from women. Participants will be asked with an interview on demographic and lifestyle characteristics, health-related behaviours, the existence and duration of infertility, medical history, and history of hormonal or surgical treatments for endometriosis. Pain symptoms will be evaluated through a 10 cm long one-dimensional visual-analogue scale (VAS). In addition, women will be asked to report about their habits about consumption of plastic

Sponsors & Collaborators

  • Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

    lead OTHER

Principal Investigators

  • Laura Buggio, MD · Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-22
Primary Completion
2023-09-30
Completion
2024-03-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05551494 on ClinicalTrials.gov