Organic Pollutants in Pelvic Endometriosis

Not Applicable

Completed

• Conditions: Endometriosis; Infertility Unexplained
• Interventions: Diagnostic Test: Detection of PAHs in visceral fat with gas chromatography-isotope dilution mass spectrometry

• Registration Number: NCT05789407
• Lead Sponsor: Jagiellonian University

Brief Summary

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

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.

Study Timeline

• Study Start: 2022-07-01
• Study First Submitted: 2023-03-05
• Study First Submitted QC: 2023-03-16
• Study First Posted: 2023-03-29
• Primary Completion: 2023-06-30
• Study Completion: 2023-10-01
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-16
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 46

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
idiopathic infertility	Detection of PAHs in visceral fat with gas chromatography-isotope dilution mass spectrometry	Women subjected to elective laparoscopy for idiopathic infertility
endometriosis	Detection of PAHs in visceral fat with gas chromatography-isotope dilution mass spectrometry	Women subjected to elective laparoscopy for pelvic endometriosis

Primary Outcome Measures

Name	Time	Method
Accumulation and detection of PAHs in women's visceral fat.	up to 6 months	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.
Comparison of concentrations of 16 reference PAHs in women in both study arms.	up to 6 months	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Jagiellonian University Medical College, Department of Gynecology and Obstetrics; 🇵🇱 Krakow, Poland