Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05551494 |
| Other study ID # |
2706 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 22, 2022 |
| Est. completion date |
March 30, 2024 |
Study information
| Verified date |
September 2022 |
| Source |
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico |
| Contact |
Paolo Vercellini, Professor |
| Phone |
0255032218 |
| Email |
paolo.vercellini[@]unimi.it |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
Description:
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.
The results of our case-control study aim to shed more light on the potential association
between endometriosis and phthalate exposure, specifically in the Italian context.
Secondary objectives include:
1. to evaluate potential variations in urinary phthalate metabolite levels in women with
different phenotypes of the disease: peritoneal endometriosis, ovarian endometriosis,
deep infiltrating endometriosis.
2. to evaluate potential variations in the levels of urinary phthalate metabolite in
endometriosis patients in relation to the presence and levels of pain symptoms
(dysmenorrhea, chronic pelvic pain, deep dyspareunia) and/or infertility.
The causality study will try to identify possible routes of exposure in everyday life and/or
working environments, which could represent a possible source of risk. The results could
identify work context in which health risks for women could be highly diversified from those
for men. This identification could support the competent doctors in defining health
surveillance protocols for specific sectors.
