Organic Pollutants in Pelvic Endometriosis

Is Exposure to Persistent Organic Pollutants Linked to Pelvic Endometriosis?

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.

Study Overview

• Status: Completed
• Conditions: Endometriosis; Infertility Unexplained
• Intervention / Treatment: Diagnostic test: Detection of PAHs in visceral fat with gas chromatography-isotope dilution mass spectrometry

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 Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Krakow, Poland, 31-501
    • Jagiellonian University Medical College, Department of Gynecology and Obstetrics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Jagiellonian University
• Investigators: Study Chair: Robert Jach, Prof., Jagiellonian University; Principal Investigator: Iwona Gawron, Ph.D., Jagiellonian University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): October 1, 2023

Study Registration Dates

• First Submitted: March 5, 2023
• First Submitted That Met QC Criteria: March 16, 2023
• First Posted (Actual): March 29, 2023

Study Record Updates

• Last Update Posted (Estimated): November 17, 2023
• Last Update Submitted That Met QC Criteria: November 16, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Endometriosis, Unexplained Infertility, Polycyclic aromatic hydrocarbons
• Additional Relevant MeSH Terms: Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Infertility; Endometriosis
• Other Study ID Numbers: 1072.6120.333.2021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No