Chronic Pelvic Pain Syndrome, Endometriosis
Conditions
Keywords
Endometriosis, Chronic Pelvic Pain Syndrome, women
Brief summary
Chronic pelvic pain (CPP) affects more than one in four women. An immune imbalance in the Th1/Th2 balance has been reported in multiple CPP situations, particularly in patients with endometriosis, but with mixed results. The use of a functional immune test, already validated in previous indications and particularly in infertility, could simulate an immune stimulation similar to that of painful attacks.
Interventions
OTHERImmune profile
The immune profile will be determined by measuring blood concentrations (in pg/mL) of pro-inflammatory and anti-inflammatory cytokines measured after non-specific stimulation of peripheral blood cells from each patient: IL4, IL5, IL12p70, 1L17A, IFNγ, IL1β, IL6, IL8, IL10, IL15, IL18, TNFα, TGFβ.
Sponsors
Centre Hospitalier Universitaire de Nice
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
1. Aged between 18 and 40; 2. Under continuous hormone treatment for at least 6 months; 3. Imaging less than 12 months old: either normal or showing endometriosis and/or adenomyosis lesions, excluding any other abnormalities that could explain the PCOS; 4. Affiliation with the French Social Security system; 5. Signature of informed consent.
Exclusion criteria
1. Pregnant or breastfeeding women; 2. Autoimmune disease; 3. History of cancer within the last 5 years or currently undergoing treatment; 4. Current infectious syndrome; 5. Person under guardianship or conservatorship.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Identify a specific immune profile in patients with chronic pelvic pain, with or without endometriosis, who have failed hormone treatment. | 24 months | Measurement of blood concentrations (in pg/mL) of pro-inflammatory and anti-inflammatory cytokines measured after non-specific stimulation of peripheral blood cells from each patient: IL4, IL5, IL12p70, 1L17A, IFNγ, IL1β, IL6, IL8, IL10, IL15, IL18, TNFα, TGFβ. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Identify a specific immune profile in patients with chronic pelvic pain associated with a neuropathic component of pain. | 24 months | As before, the immune profile will be determined by measuring the blood concentrations (in pg/mL) of pro-inflammatory and anti-inflammatory cytokines after non-specific stimulation of peripheral blood cells : IL4, IL5, IL12p70, 1L17A, IFNγ, IL1β, IL6, IL8, IL10, IL15, IL18, TNFα, TGFβ. We will then make comparison between the immune profiles of patients with chronic pelvic pain, whether or not associated with a DN4 score ≥4/10. |
| Identify a specific immune profile in patients with chronic pelvic pain associated with pelvic pain sensitization. | 24 months | The immune profile will be determined by measuring the blood concentrations (in pg/mL) of pro-inflammatory and anti-inflammatory cytokines after non-specific stimulation of peripheral blood cells : IL4, IL5, IL12p70, 1L17A, IFNγ, IL1β, IL6, IL8, IL10, IL15, IL18, TNFα, TGFβ. We will then make comparisons between the different profiles studied: Compare the immune profiles of patients with chronic pelvic pain, whether or not associated with a Convergence PP score ≥ 5/10. |
| Identify a specific immune profile in patients with chronic pelvic pain associated with infertility | 24 months | The immune profile will be determined by measuring the blood concentrations (in pg/mL) of pro-inflammatory and anti-inflammatory cytokines after non-specific stimulation of peripheral blood cells : IL4, IL5, IL12p70, 1L17A, IFNγ, IL1β, IL6, IL8, IL10, IL15, IL18, TNFα, TGFβ. . We will then make comparison between the different profiles studied: Compare the immune profiles of patients with chronic pelvic pain, with or without clinical infertility (no pregnancy after 12 months of unprotected intercourse). |
| Identify a specific immune profile in patients with chronic pelvic pain associated with endometriosis | 24 months | The immune profile will be determined by measuring the blood concentrations (in pg/mL) of pro-inflammatory and anti-inflammatory cytokines after non-specific stimulation of peripheral blood cells : IL4, IL5, IL12p70, 1L17A, IFNγ, IL1β, IL6, IL8, IL10, IL15, IL18, TNFα, TGFβ. We will then make comparison between the immune profiles of patients with chronic pelvic pain, whether or not associated with endometriosis confirmed by imaging at a reference center (according to compliance with the positivity criteria of the protocol and the French ENDOVALIRM reference system (to characterize deep lesions on MRI) and/or the ESUR 2017 reference system (for ovarian lesions) and/or the SUR-US 2024 reference system (for ultrasound)). |
| Identify a specific immune profile in patients with chronic pelvic pain based on symptom severity and the extent of endometriosis lesions on imaging. | 24 months | The immune profile will be determined by measuring the blood concentrations (in pg/mL) of pro-inflammatory and anti-inflammatory cytokines after non-specific stimulation of peripheral blood cells : IL4, IL5, IL12p70, 1L17A, IFNγ, IL1β, IL6, IL8, IL10, IL15, IL18, TNFα, TGFβ. . We will then make comparison between the immune profiles of patients with chronic pelvic pain in the context of endometriosis, according to the location of the lesions (ovarian, deep or superficial). |
Countries
France
Contacts
CONTACTPierre-Alexis GAUCI, MD
Outcome results
None listed