Infertility Clinical Trial
— METABOLENDOOfficial title:
Metabolomic Profile in Women With and Without Endometriosis: a Case-control Study
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.
Status | Recruiting |
Enrollment | 400 |
Est. completion date | February 28, 2024 |
Est. primary completion date | October 31, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility | Inclusion Criteria: 1. Endometriosis group. - are women aged 18-45 - histologically confirmed diagnosis of endometriosis consecutively observed at the "Endometriosis center" Fondazione IRCCS Ospedale Maggiore Policlinico, Milan. - Only incident cases (i.e. diagnosis within three months before study entry) will be eligible. 2. Control group are women aged 18-45 surgically verified not to have endometriosis. In this group, the indications for surgery will be abdominal surgical emergencies, tubal infertility, non-endometriotic ovarian cysts, or uterine fibroids. Controls will be identified consecutively at the same institution where cases have been identified. Exclusion Criteria: 1. Endometriosis group: - the presence of diseases causing pelvic pain other than endometriosis, - hormonal treatment in the past two months before surgery, - menopausal state - pregnancy - gynecological cancers - pelvic inflammatory disease 2. Control group: - hormonal treatment in the past two months before surgery - menopausal state - pregnancy - gynecological cancers. - pelvic inflammatory disease |
Country | Name | City | State |
---|---|---|---|
Italy | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico | Milan |
Lead Sponsor | Collaborator |
---|---|
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Determination of plasma metabolomic profile using an LC-MS/MS targeted metabolomic method | Potential variations in the plasma metabolomic profile of endometriosis patients as a consequence of pathophysiologic alterations associated with this disorder. Metabolomic set-up will be evaluated with a targeted approach and instrumentation based on the triple quadrupole mass Spectrometry interfaced with liquid chromatography at very high pressure. Metabolomic profile analysis of subjects will be conducted using a targeted LC-MS/MS metabolomic method through the AbsoluteIDQ kit¹ p180. A good inter-laboratory reproducibility of this test was reported for measurements of the above metabolites in human plasma. The instrumentation will consist of a high pressure liquid chromatograph Agilent coupled with hybrid triple quadrupole/linear ion trap mass spectrometer with an electrospray ionization source. The test shall be conducted according to the manufacturer's instructions. | 24 months | |
Secondary | Relation between Plasma metabolomic profile and endometriosis phenotypes through a questionnaire | We expect that women in the endometriosis group will differ with regard to metabolomic profile with respect to the disease phenotype different phenotypes of the disease: peritoneal endometriosis, ovarian endometriosis, deep infiltrating endometriosis. We will not use for this outcome no scale. | 24 months | |
Secondary | Plasma metabolomic profile and fertility in terms of pregnancy rate | we expect that women in the endometriosis group will differ with regard to metabolomic profile with respect the presence infertility | 24 months | |
Secondary | Relation between Plasma metabolomic profile and pelvic pain evaluated through visual-analogue scale (VAS) | we expect that women in the endometriosis group will differ with regard to metabolomic profile with respect the presence of endometriosis-related painful symptoms. VAS scale, from 1 meaning better outcome to 10 meaning worse outcome. | 24 months | |
Secondary | Plasma metabolomic profile and dietary exposure through food frequency questionnaire (FFQ) | we expect that women in the endometriosis group will differ with regard to metabolomic profile with respect the dietary exposure. 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 (doi: 10.1016/j.rbmo.2020.07.011. ) | 24 months |
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