Not yet recruitingNAINTERVENTIONAL

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

This study, called ImmunoCPP, is for women aged 18 to 40 who suffer from long-lasting pelvic pain, particularly those with conditions like endometriosis, whose current treatments haven't fully helped. We know that up to one in four women experience chronic pelvic pain, and sometimes the body's immune system might play a role in this pain. Previous research has hinted at immune system differences in these women, but the findings have been unclear. This project plans to use a special immune test, which has been used before in fertility studies, to see how immune cells react as if they were experiencing a painful flare-up. By understanding these immune responses better, we hope to find new ways to understand and treat chronic pelvic pain more effectively.

At a glance

Status

Not yet recruiting

Phase

Sponsor

Centre Hospitalier Universitaire de Nice

Enrolment target

120

Start

01 Apr 2026

Estimated completion

01 Apr 2028

Endometriosis Chronic Pelvic Pain Syndrome

What is this study about?

Many women experience chronic pelvic pain, which means pain in their lower tummy area that lasts for a long time. For some, this pain is very difficult to manage, even after trying common treatments. Sometimes, conditions like endometriosis, where tissue similar to the womb lining grows outside the womb, can be a cause of this pain, but not always.

Our bodies have an immune system that helps fight off infections and illnesses. However, sometimes the immune system can become out of balance or react in ways that cause problems. Past research has suggested that there might be differences in the immune systems of women with long-lasting pelvic pain, especially those with endometriosis. This study wants to look more closely at this idea.

We will be using a special test that has been used before, for example, in studies about fertility. This test can show how certain immune cells react when they are stimulated, almost like when the body is experiencing a painful episode. By doing this, we hope to identify a specific 'immune fingerprint' in women who have chronic pelvic pain that hasn't responded well to their usual treatments. Understanding this could open doors to new and more personalised treatments in the future.

Key takeaways

Study focused on understanding immune system in chronic pelvic pain.
Aims to help women aged 18-40 with long-lasting pelvic pain.
Specifically looking at those with endometriosis and unresponsive to standard treatments.
No new treatments or medications involved, mainly blood tests.
Your participation helps future research into better pain management.
You can stop participating at any time without affecting your care.

Who may be eligible?

This study is looking for women who are between 18 and 40 years old. You should have ongoing pelvic pain that hasn't cleared up with standard treatments, and you must have been on continuous hormone treatment for at least six months.

We also need to make sure that any imaging tests, like scans, you've had in the last year either looked normal or showed endometriosis or adenomyosis (a condition similar to endometriosis but in the muscle wall of the womb). It's important that these scans didn't show any other problems that could explain your pain.

You won't be able to join if you are pregnant or breastfeeding, have an autoimmune disease (where your immune system attacks your own body), have had cancer in the last five years, or are currently being treated for cancer. You also can't take part if you have an infection right now or if you are under legal guardianship.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you a woman between 18 and 40 years old?
Have you been taking continuous hormone treatment for at least 6 months?
Do you have chronic pelvic pain that hasn't been helped by usual treatments?
Have scans in the last year shown normal results, endometriosis, or adenomyosis, with no other explanations for your pain?
Are you NOT pregnant or breastfeeding?
Do you NOT have an autoimmune disease or a recent history of cancer?

Answer every question to see your result.

What does participation involve?

As this study aims to identify features of your immune system, it is likely to involve a blood test. You would give a blood sample, and then researchers would analyse what happens to certain immune cells when they are stimulated. The study does not involve taking new medications or treatments. You would continue with your current hormone treatment as usual. The total duration of your involvement in the study would likely be short, possibly limited to one or two visits for providing the sample and any necessary consent forms.

Potential risks and benefits

Participating in this study will not directly benefit your current pain, as it's purely for research purposes to understand the causes of chronic pelvic pain better. However, by taking part, you could contribute valuable information that might lead to better understanding and future treatments for other women with similar conditions. The main risk involved would be the minor discomfort and bruising from a blood test. You are completely free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

CHU Nice - Hôpital de l'Archet 2
Verified postcode
Nice, France

Common questions

What is chronic pelvic pain?

Chronic pelvic pain is ongoing pain in the lower stomach area that lasts for six months or more.

What is endometriosis?

Endometriosis is a condition where tissue similar to the lining of the womb grows outside of it, causing pain and other symptoms.

Will this study give me a new treatment?

No, this study is about research and understanding. It won't offer a new treatment, but it could help develop future treatments.

What is an immune profile?

An immune profile looks at how active certain parts of your immune system are and how they respond, like taking a 'snapshot' of your immune health.

How long will my involvement in the study last?

Your involvement in this study would likely be short, potentially just one or two visits to give blood samples.

How to find out more

Pierre-Alexis GAUCI, MD

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

Always speak to your GP or specialist before deciding to take part in a study.