Metabolomic Profile in Women With and Without Endometriosis

Summary

The pathogenesis of endometriosis is very complex as several factors, including genetic, environmental and lifestyle-related factors, are involved in the development, progression and maintenance of the disease. In particular, there are emerging evidences that prostaglandin metabolism, chronic inflammatory processes and circulating estrogen levels are involved in the pathogenesis of endometriosis. Pelvic pain, in particular dysmenorrhea, is the most typical symptom caused by the production of prostaglandins and pain mediators associated with the peritoneal inflammatory state.

Metabolomics strives to measure all metabolites, such as sugars, amino acids, acylcarnitines, organic acids, and lipids, present in a given biological sample. Thus, metabolomics represents a reflection of phenotypic changes in an organism in response to the presence of a certain disease, genetic changes, and nutritional, toxicological, environmental, and pharmacological influences, providing a means to more accurately capture exogenous exposures and evaluate endogenous biomarkers.

Regarding endometriosis, the targeted metabolomics studies focused mainly on lipids, and the non-targeted studies also identified mainly lipids, amino acids, and intermediary metabolites as the most important variables.

The combinations of metabolomics data together with clinical ones are of utmost importance in endometriosis research. This approach might lead to the construction of models/algorithms useful to better define diagnostic/prognostic characteristics of women who have endometriosis, identify environmental and modifiable risk factors, elucidate pathogenetic mechanisms, and contribute to better tailor medical treatments.

In particular, metabolomics may provide a means to capture exogenous exposures and evaluate endogenous biomarkers more accurately.

The main objective of the present research project is to evaluate potential variations in the plasma metabolomic profile of women affected by endometriosis (as compared with a control group) as a consequence of pathophysiologic alterations associated with this disorder.

Secondary objectives are:

1. to evaluate potential variations in the plasma metabolomic profile of endometriosis patients with different phenotypes of the disease: peritoneal endometriosis, ovarian endometriosis, deep infiltrating endometriosis;
2. to evaluate potential variations in the plasma metabolomic profile of endometriosis patients in relation to the presence of endometriosis-related painful symptoms and/or infertility.

There is strong evidence that endometriosis has a negative impact on women's quality of life, with severe long-term consequences and substantial social costs. Our findings might lead to the construction of models/algorithms useful to better define diagnostic/prognostic characteristics of women who have endometriosis, identify environmental and modifiable risk factors, elucidate pathogenetic mechanisms, and contribute to better tailoring medical treatments.

Conditions

• Endometriosis
• Endometriosis-related Pain
• Infertility

Interventions

DIAGNOSTIC_TEST

Blood samples

At study entry, we will collect morning blood samples from fasting 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 before surgery will be evaluated through a 10 cm long one-dimensional visual-analogue scale (VAS). In addition, women will be asked to report about their usual weekly food consumption in the previous year. Information on the diet will be based on a reproducible and valid food frequency questionnaire. Energy and mineral and macro-and micronutrient intakes will be estimated using the most recent update of an Italian Food Consumption Database.

Sponsors & Collaborators

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

  lead OTHER

Principal Investigators

• Paolo Vercellini, Prof. · Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Study Design

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-04-09

Primary Completion

2023-10-31

Completion

2024-02-28

Countries

• Italy

Study Locations