Identify a Specific Immune Profile in Patients With Chronic Pelvic Pain Resistant to First-line Treatments by Measuring Th1, Th2, Th17, and Treg Cytokines Produced After Non-specific Functional Cell Stimulation - ImmunoCPP

Sponsor
Centre Hospitalier Universitaire de Nice
Study ID
NCT07429773
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 40 Years
Healthy Volunteers
Not accepted

Interventions

  • Immune profile — OTHER
    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.

Study Details

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.

Key Dates

First listed
Feb 24, 2026
Start date
Apr 14, 2026
Status verified
Jul 2026
Primary completion
Apr 30, 2028
Completion
Apr 30, 2028

Study Design

Enrollment
120 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Group 1 : Patients with pelvic pain
    Patients with chronic pelvic pain resistant to hormone therapy
  • Experimental: Group 2 : Asymptomatic patients
    Asymptomatic patients undergoing hormone therapy

Primary Outcome Measure

Identify a specific immune profile in patients with chronic pelvic pain, with or without endometriosis, who have failed hormone treatment. [ Time Frame: 24 months ]

Central Contacts

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