Clinical trial NCT05789407: Organic Pollutants in Pelvic Endometriosis
Official title: Is Exposure to Persistent Organic Pollutants Linked to Pelvic Endometriosis?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometriosis
Infertility Unexplained
Keywords: Endometriosis, Unexplained Infertility, Polycyclic aromatic hydrocarbons
Lead sponsor: Jagiellonian University
Sponsor class: OTHER
First posted: 2023-03-29
Enrollment: 46
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility criteria: 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:

-

Primary outcomes:
measure: Accumulation and detection of PAHs in women's visceral fat.
timeFrame: up to 6 months
measure: Comparison of concentrations of 16 reference PAHs in women in both study arms.
timeFrame: up to 6 months
Secondary outcomes:
measure: Evaluation of PAHs concentrations correlation with endometriosis degree
timeFrame: up to 6 months
measure: Evaluation of PAHs concentrations correlation with the intensity of pelvic pain
timeFrame: up to 6 months
measure: Evaluation of PAHs concentrations correlation with the presence and severity of peritoneal adhesions
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Krakow
country: Poland
facility: Jagiellonian University Medical College, Department of Gynecology and Obstetrics
Study officials:
affiliation: Jagiellonian University
name: Robert Jach, Prof.
role: STUDY_CHAIR
affiliation: Jagiellonian University
name: Iwona Gawron, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: