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NCT Number: NCT05789407

Organic Pollutants in 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.

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Key information

Conditions

Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infertility Unexplained Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Jagiellonian University Medical College, Department of Gynecology and Obstetrics

Krakow, 31-501, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

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

Primary outcomes

  1. Accumulation and detection of PAHs in women's visceral fat.

    Time frame: 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.

    Time frame: 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 outcomes

  1. Evaluation of PAHs concentrations correlation with endometriosis degree

    Time frame: 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

    Time frame: 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

    Time frame: up to 6 months

    Assessment of 16 PAHs concentrations depending on the presence and severity of peritoneal adhesions using standard statistical methods.

Sponsors and collaborators

Lead sponsor

Jagiellonian University

Other

Registry information

Official study title

Is Exposure to Persistent Organic Pollutants Linked to Pelvic Endometriosis?

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 29, 2023
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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