Urinary Concentration of Phthalate Metabolites in Women With and Without Endometriosis

NCT05551494 | Unknown

• 1 other identifier: 2706
• Study Type: observational
• Target: 440
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

phthalates; urinary biomarkers; endometriosis

Outcome Measures

Primary Outcomes (1)

• Evaluate urinary concentration of phthalates

  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

  24 months

Secondary Outcomes (4)

• Variations in urinary concentration phthalate metabolite levels in women with different phenotypes of the disease

  24 months

• 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

• Identify work context in which health risks for women could be highly than for men

  24 months

Study Arms (2)

Endometriosis group

Cases will include women aged 18-45 with a surgical diagnosis of endometriosis in the previous 24 months or with a current nonsurgical diagnosis of endometriosis who report having lived in the past ten years in the Lombardy area. At study entry, we will collect urinary sample.

Diagnostic Test: Urinary sample

Control group

Control group are women aged 18-45 attending our outpatient clinic for periodical gynaecological care, contraception, or cervical cancer screening programme, and without a previous clinical or surgical diagnosis of endometriosis who report having lived in the past ten years in the Lombardy area. At study entry, we will collect urinary sample.

Diagnostic Test: Urinary sample

Interventions

Urinary sample DIAGNOSTIC_TEST

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

Control group; Endometriosis group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

In this study will be recruited women with or without endometriosis, aged 18-45 years who have lived in the last 10 years in the Lombardy area. Will be excluded women with uterine fibroids, gynecological cancers or renal, hepatic, cardiovascular disease, diabetes or high blood pressure

You may qualify if:

• 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.

You may not qualify if:

• Pregnancy
• Uterine fibroids, gynecological cancers
• Renal, hepatic, cardiovascolar disease, diabetes or high blood pressure

Sponsors & Collaborators

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: lead

Study Sites (1)

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Milan, 20122, Italy

RECRUITING

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Laura Buggio, MD

  Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paolo Vercellini, Professor

CONTACT

0255032218; paolo.vercellini@unimi.it

Laura Buggio, MD

CONTACT

0255032218; laura.buggio@policlinico.mi.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 23, 2022
• First Posted: September 22, 2022
• Study Start: March 22, 2022
• Primary Completion: September 30, 2023
• Study Completion: March 30, 2024
• Last Updated: September 22, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)