Organic Pollutants in Pelvic Endometriosis
Primary Purpose
Endometriosis, Infertility Unexplained
Status
Recruiting
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Detection of PAHs in visceral fat with gas chromatography-isotope dilution mass spectrometry
Sponsored by
About this trial
This is an interventional diagnostic trial for Endometriosis focused on measuring Endometriosis, Unexplained Infertility, Polycyclic aromatic hydrocarbons
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: -
Sites / Locations
- Jagiellonian University Medical College, Department of Gynecology and ObstetricsRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
endometriosis
idiopathic infertility
Arm Description
Women subjected to elective laparoscopy for pelvic endometriosis
Women subjected to elective laparoscopy for idiopathic infertility
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Evaluation of PAHs concentrations correlation with endometriosis degree
Assessment of 16 PAHs concentrations depending on the degree of endometriosis severity using standard statistical methods.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05789407
Brief Title
Organic Pollutants in Pelvic Endometriosis
Official Title
Is Exposure to Persistent Organic Pollutants Linked to Pelvic Endometriosis?
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jagiellonian University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis, Infertility Unexplained
Keywords
Endometriosis, Unexplained Infertility, Polycyclic aromatic hydrocarbons
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
endometriosis
Arm Type
Experimental
Arm Description
Women subjected to elective laparoscopy for pelvic endometriosis
Arm Title
idiopathic infertility
Arm Type
Active Comparator
Arm Description
Women subjected to elective laparoscopy for idiopathic infertility
Intervention Type
Diagnostic Test
Intervention Name(s)
Detection of PAHs in visceral fat with gas chromatography-isotope dilution mass spectrometry
Intervention Description
1 ml sample of visceral fat collected during elective laparoscopy for detection of PAHS by gas chromatography-isotope dilution mass spectrometry
Primary Outcome Measure Information:
Title
Accumulation and detection of PAHs in women's visceral fat.
Description
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.
Time Frame
up to 6 months
Title
Comparison of concentrations of 16 reference PAHs in women in both study arms.
Description
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.
Time Frame
up to 6 months
Secondary Outcome Measure Information:
Title
Evaluation of PAHs concentrations correlation with endometriosis degree
Description
Assessment of 16 PAHs concentrations depending on the degree of endometriosis severity using standard statistical methods.
Time Frame
up to 6 months
Title
Evaluation of PAHs concentrations correlation with the intensity of pelvic pain
Description
Assessment of 16 PAHs concentrations depending the intensity of pelvic pain in Numeric Rating Scale using standard statistical methods.
Time Frame
up to 6 months
Title
Evaluation of PAHs concentrations correlation with the presence and severity of peritoneal adhesions
Description
Assessment of 16 PAHs concentrations depending on the presence and severity of peritoneal adhesions using standard statistical methods.
Time Frame
up to 6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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:
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Iwona Gawron, Ph.D.
Phone
+48 12 4248570
Email
iwona.gawron@uj.edu.pl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Jach, Prof.
Organizational Affiliation
Jagiellonian University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Iwona Gawron, Ph.D.
Organizational Affiliation
Jagiellonian University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jagiellonian University Medical College, Department of Gynecology and Obstetrics
City
Krakow
ZIP/Postal Code
31-501
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Iwona Gawron, Ph.D.
Phone
+48 124248570
Email
iwona.gawron@uj.edu.pl
12. IPD Sharing Statement
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Organic Pollutants in Pelvic Endometriosis
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