Organic Pollutants in Pelvic Endometriosis

NCT05789407 | Completed DMC

• 1 other identifier: 1072.6120.333.2021
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometriosis; Infertility Unexplained

Keywords

Endometriosis, Unexplained Infertility, Polycyclic aromatic hydrocarbons

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Evaluation of PAHs concentrations correlation with endometriosis degree

  up to 6 months

• Evaluation of PAHs concentrations correlation with the intensity of pelvic pain

  up to 6 months

• Evaluation of PAHs concentrations correlation with the presence and severity of peritoneal adhesions

  up to 6 months

Study Arms (2)

endometriosis

EXPERIMENTAL

Women subjected to elective laparoscopy for pelvic endometriosis

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

idiopathic infertility

ACTIVE COMPARATOR

Women subjected to elective laparoscopy for idiopathic infertility

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

Interventions

Detection of PAHs in visceral fat with gas chromatography-isotope dilution mass spectrometry DIAGNOSTIC_TEST

1 ml sample of visceral fat collected during elective laparoscopy for detection of PAHS by gas chromatography-isotope dilution mass spectrometry

endometriosis; idiopathic infertility

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• i) age 18-45, ii) indications for surgical treatment of endometriosis, iii) indications for invasive diagnostics and surgical treatment of idiopathic infertility.

Sponsors & Collaborators

• Jagiellonian University: lead

Study Sites (1)

Jagiellonian University Medical College, Department of Gynecology and Obstetrics

Krakow, 31-501, Poland

Location

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Robert Jach, Prof.

  Jagiellonian University

  STUDY CHAIR

• Iwona Gawron, Ph.D.

  Jagiellonian University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D., Principal Investigator

Model Details: A prospective cohort tertiary-center study among women undergoing elective laparoscopy due to pelvic endometriosis (arm 1) or idiopathic infertility (arm 2).

Study Record Dates

• First Submitted: March 5, 2023
• First Posted: March 29, 2023
• Study Start: July 1, 2022
• Primary Completion: June 30, 2023
• Study Completion: October 1, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

PL (1)