Organic Pollutants in Pelvic Endometriosis

NCT ID: NCT05789407

Last Updated: 2023-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-01

Study Completion Date

2023-10-01

Brief Summary

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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

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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.

Conditions

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Endometriosis Infertility Unexplained

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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endometriosis

Women subjected to elective laparoscopy for pelvic endometriosis

Group Type EXPERIMENTAL

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

Intervention Type DIAGNOSTIC_TEST

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

idiopathic infertility

Women subjected to elective laparoscopy for idiopathic infertility

Group Type ACTIVE_COMPARATOR

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

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Jagiellonian University

OTHER

Sponsor Role lead

Responsible Party

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Iwona Magdalena Gawron

Ph.D., Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Robert Jach, Prof.

Role: STUDY_CHAIR

Jagiellonian University

Iwona Gawron, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Jagiellonian University

Locations

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Jagiellonian University Medical College, Department of Gynecology and Obstetrics

Krakow, , Poland

Site Status

Countries

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Poland

Other Identifiers

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1072.6120.333.2021

Identifier Type: -

Identifier Source: org_study_id

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