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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
120
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.
CHU Nice - Hôpital de l'Archet 2
Nice, Alpes-Maritimes, France
RECRUITINGIdentify a specific immune profile in patients with chronic pelvic pain, with or without endometriosis, who have failed hormone treatment.
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.
Time frame: 24 months
Identify a specific immune profile in patients with chronic pelvic pain associated with a neuropathic component of pain.
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.
Time frame: 24 months
Identify a specific immune profile in patients with chronic pelvic pain associated with pelvic pain sensitization.
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.
Time frame: 24 months
Identify a specific immune profile in patients with chronic pelvic pain associated with infertility
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).
Time frame: 24 months
Identify a specific immune profile in patients with chronic pelvic pain associated with endometriosis
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)).
Time frame: 24 months
Identify a specific immune profile in patients with chronic pelvic pain based on symptom severity and the extent of endometriosis lesions on imaging.
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).
Time frame: 24 months
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