Organic Pollutants in Pelvic Endometriosis

Study Overview
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Brief Summary
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The health toxicity of polycyclic aromatic hydrocarbons (PAHs), present in air and food, generated during energy production and waste incineration, is well known. PAHs can activate the aryl hydrocarbon receptor, which may interact with classic estrogen receptors and modify estrogen-dependent inflammation in endometriosis. There is no data on the hypothetical role of PAHs in the etiopathogenesis of endometriosis. The aim was to compare PAHs concentrations in visceral fat in women with endometriosis and idiopathic infertility.

Detailed Description
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A prospective cohort tertiary-center study includes women undergoing laparoscopy due to pelvic endometriosis (arm 1) or/and idiopathic infertility (arm 2). A sample of 1 ml of the greater omentum is collected intraoperatively for detection of 16 PAHs, i.e. acenaphthene, acenaphthylene, anthracene, fluoranthene, fluorene, naphthalene, phenanthrene, pyrene, benz[a]anthracene, benzo[b]fluoranthene, benzo[k]fluoranthene, benzo[ghi]perylene, benzo[a]pyrene, chrysene, dibenz[a,h]anthracene, and indeno[1,2,3-cd]pyrene, by gas chromatography-isotope dilution mass spectrometry method. The concentration of selected PAHs in visceral fat in both populations will be compared. The correlation of concentrations of selected PAHs with the occurrence of infertility, pelvic pain syndrome, intensity of pain, peritoneal adhesions and the degree of endometriosis will be checked.

Official Title
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Is Exposure to Persistent Organic Pollutants Linked to Pelvic Endometriosis?

Conditions
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Endometriosis, Infertility Unexplained

Intervention / Treatment
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* Diagnostic Test: Detection of PAHs in visceral fat with gas chromatography-isotope dilution mass spectrometry


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: i) age 18-45, ii) indications for surgical treatment of endometriosis, iii) indications for invasive diagnostics and surgical treatment of idiopathic infertility. Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A prospective cohort tertiary-center study among women undergoing elective laparoscopy due to pelvic endometriosis (arm 1) or idiopathic infertility (arm 2).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: endometriosis<br>Women subjected to elective laparoscopy for pelvic endometriosis | Diagnostic Test: Detection of PAHs in visceral fat with gas chromatography-isotope dilution mass spectrometry<br>* 1 ml sample of visceral fat collected during elective laparoscopy for detection of PAHS by gas chromatography-isotope dilution mass spectrometry<br>|
| Active Comparator: idiopathic infertility<br>Women subjected to elective laparoscopy for idiopathic infertility | Diagnostic Test: Detection of PAHs in visceral fat with gas chromatography-isotope dilution mass spectrometry<br>* 1 ml sample of visceral fat collected during elective laparoscopy for detection of PAHS by gas chromatography-isotope dilution mass spectrometry<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accumulation and detection of PAHs in women's visceral fat. | Detection and confirmation of the accumulation of PAHs (acenaphthene, acenaphthylene, anthracene, fluoranthene, fluorene, naphthalene, phenanthrene, pyrene, benz[a]anthracene, benzo[b]fluoranthene, benzo[k]fluoranthene, benzo[ghi]perylene, benzo[a]pyrene, chrysene, dibenz[a,h]anthracene, and indeno[1,2,3-cd]pyrene) in human adipose tissue by gas chromatography-isotope dilution mass spectrometry method. | up to 6 months | 
| Comparison of concentrations of 16 reference PAHs in women in both study arms. | Comparison of concentrations of 16 PAHs (acenaphthene, acenaphthylene, anthracene, fluoranthene, fluorene, naphthalene, phenanthrene, pyrene, benz[a]anthracene, benzo[b]fluoranthene, benzo[k]fluoranthene, benzo[ghi]perylene, benzo[a]pyrene, chrysene, dibenz[a,h]anthracene, and indeno[1,2,3-cd]pyrene) in both study arms using standard statistical methods. | up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of PAHs concentrations correlation with endometriosis degree | Assessment of 16 PAHs concentrations depending on the degree of endometriosis severity using standard statistical methods. | up to 6 months | 
| Evaluation of PAHs concentrations correlation with the intensity of pelvic pain | Assessment of 16 PAHs concentrations depending the intensity of pelvic pain in Numeric Rating Scale using standard statistical methods. | up to 6 months | 
| Evaluation of PAHs concentrations correlation with the presence and severity of peritoneal adhesions | Assessment of 16 PAHs concentrations depending on the presence and severity of peritoneal adhesions using standard statistical methods. | up to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endometriosis, Unexplained Infertility, Polycyclic aromatic hydrocarbons