Organic Pollutants in Pelvic Endometriosis

Endometriosis Clinical Trial

Official title:

Is Exposure to Persistent Organic Pollutants Linked to Pelvic Endometriosis?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05789407
• Other study ID #: 1072.6120.333.2021
• Status: Completed
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: October 1, 2023

Study information

• Verified date: November 2023
• Source: Jagiellonian University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: October 1, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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: -

Related Conditions & MeSH terms

• Endometriosis
• Infertility
• Infertility Unexplained

Intervention

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

Locations

Country	Name	City	State
Poland	Jagiellonian University Medical College, Department of Gynecology and Obstetrics	Krakow

Sponsors (1)

Lead Sponsor	Collaborator
Jagiellonian University

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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