NCT07429773

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
20mo left

Started Apr 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress15%
Apr 2026Apr 2028

First Submitted

Initial submission to the registry

January 21, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 24, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

April 14, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2028

Last Updated

July 27, 2026

Status Verified

July 1, 2026

Enrollment Period

2 years

First QC Date

January 21, 2026

Last Update Submit

July 24, 2026

Conditions

EndometriosisChronic Pelvic Pain Syndrome

Keywords

EndometriosisChronic Pelvic Pain Syndromewomen

Outcome Measures

Primary Outcomes (1)

  • Identify 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.

    24 months

Secondary Outcomes (5)

  • Identify a specific immune profile in patients with chronic pelvic pain associated with a neuropathic component of pain.

    24 months

  • Identify a specific immune profile in patients with chronic pelvic pain associated with pelvic pain sensitization.

    24 months

  • Identify a specific immune profile in patients with chronic pelvic pain associated with infertility

    24 months

  • Identify a specific immune profile in patients with chronic pelvic pain associated with endometriosis

    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.

    24 months

Study Arms (2)

Group 1 : Patients with pelvic pain

EXPERIMENTAL

Patients with chronic pelvic pain resistant to hormone therapy

Other: Immune profile

Group 2 : Asymptomatic patients

EXPERIMENTAL

Asymptomatic patients undergoing hormone therapy

Other: Immune profile

Interventions

Immune profileOTHER

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.

Group 1 : Patients with pelvic painGroup 2 : Asymptomatic patients

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Aged between 18 and 40;
  • Under continuous hormone treatment for at least 6 months;
  • Imaging less than 12 months old: either normal or showing endometriosis and/or adenomyosis lesions, excluding any other abnormalities that could explain the PCOS;
  • Affiliation with the French Social Security system;
  • Signature of informed consent.

You may not qualify if:

  • Pregnant or breastfeeding women;
  • Autoimmune disease;
  • History of cancer within the last 5 years or currently undergoing treatment;
  • Current infectious syndrome;
  • Person under guardianship or conservatorship.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Nice - Hôpital de l'Archet 2

Nice, Alpes-Maritimes, 06200, France

RECRUITING

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Central Study Contacts

Pierre-Alexis GAUCI, MD

CONTACT

04 92 03 61 90gauci.pa@chu-nice.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2026

First Posted

February 24, 2026

Study Start

April 14, 2026

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

April 1, 2028

Last Updated

July 27, 2026

Record last verified: 2026-07

Locations

FR(1)