Organic Pollutants in Pelvic Endometriosis

Sponsor
Jagiellonian University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05789407
Collaborator
(none)
50
1
2
18
2.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Detection of PAHs in visceral fat with gas chromatography-isotope dilution mass spectrometry
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
A prospective cohort tertiary-center study among women undergoing elective laparoscopy due to pelvic endometriosis (arm 1) or idiopathic infertility (arm 2).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)
Primary Purpose:
Diagnostic
Official Title:
Is Exposure to Persistent Organic Pollutants Linked to Pelvic Endometriosis?
Actual Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Jun 30, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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

  1. 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.

  2. 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.

  3. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. age 18-45, ii) indications for surgical treatment of endometriosis, iii) indications for invasive diagnostics and surgical treatment of idiopathic infertility.
Exclusion Criteria:

Contacts and Locations

Locations

Site City State Country Postal Code
1 Jagiellonian University Medical College, Department of Gynecology and Obstetrics Krakow Poland 31-501

Sponsors and Collaborators

  • Jagiellonian University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Iwona Magdalena Gawron, Ph.D., Principal Investigator, Jagiellonian University
ClinicalTrials.gov Identifier:
NCT05789407
Other Study ID Numbers:
  • 1072.6120.333.2021
First Posted:
Mar 29, 2023
Last Update Posted:
Mar 29, 2023
Last Verified:
Mar 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Iwona Magdalena Gawron, Ph.D., Principal Investigator, Jagiellonian University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 29, 2023