EndometriosisImmunoCPPNCT07429773
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
A study testing Immune profile in people with Endometriosis and Chronic Pelvic Pain Syndrome, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Endometriosis, Chronic Pelvic Pain Syndrome
- What is being tested?
- Immune profile
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 14 Apr 2026to Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Nice - Hôpital de l'Archet 2
Nice, Alpes-Maritimes, 06200
Pierre-Alexis GAUCI, MD, 04 92 03 61 90 ext. +33, gauci.pa@chu-nice.fr
About this study
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.
- Conditions
- Endometriosis, Chronic Pelvic Pain Syndrome
- Being tested
- Immune profile
- Keywords
- Endometriosis, Chronic Pelvic Pain Syndrome, women
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 : Patients with pelvic pain | Experimental | Patients with chronic pelvic pain resistant to hormone therapy Receives: Other: Immune profile |
| Group 2 : Asymptomatic patients | Experimental | Asymptomatic patients undergoing hormone therapy Receives: Other: Immune profile |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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).
Measured: 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)).
Measured: 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).
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start14 Apr 2026
- Primary completionApr 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07429773
- Sponsor's protocol ID
- 25-AOI-07
- Acronym
- ImmunoCPP
- Status last verified
- Jul 2026
- First submitted
- 21 Jan 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07429773
- Acronym / sponsor ID
- ImmunoCPP / 25-AOI-07
- Conditions
- Endometriosis, Chronic Pelvic Pain Syndrome
- Keywords
- Endometriosis, Chronic Pelvic Pain Syndrome, women
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 14 Apr 2026 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 24 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 : Patients with pelvic pain | Experimental | Other: Immune profilePatients with chronic pelvic pain resistant to hormone therapy |
| Group 2 : Asymptomatic patients | Experimental | Other: Immune profileAsymptomatic patients undergoing hormone therapy |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immune profileThe 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. | Other | Group 1 : Patients with pelvic pain, Group 2 : Asymptomatic patients |
Primary outcome
Identify a specific immune profile in patients with chronic pelvic pain, with or without endometriosis, who have failed hormone treatment.
Time frame: 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.
5 secondary outcomes
Identify a specific immune profile in patients with chronic pelvic pain associated with a neuropathic component of pain.
Time frame: 24 months
Identify a specific immune profile in patients with chronic pelvic pain associated with pelvic pain sensitization.
Time frame: 24 months
Identify a specific immune profile in patients with chronic pelvic pain associated with infertility
Time frame: 24 months
Identify a specific immune profile in patients with chronic pelvic pain associated with endometriosis
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.
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immune profile in people with Endometriosis and Chronic Pelvic Pain Syndrome, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pierre-Alexis GAUCI, MD (04 92 03 61 90 ext. +33, gauci.pa@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.