RecruitingOBSERVATIONAL

Multicenter Study for Diagnostic Validation of a Laboratory Test for the Diagnosis of Endometriosis

Endometriosis affects many women and can take years to diagnose, usually requiring surgery. This study is testing a new, easier way to diagnose it using a blood test from menstrual samples. Researchers want to see if this test can accurately find endometriosis by looking for special markers in the blood. They are inviting women aged 14 to 49, some with confirmed endometriosis and some without, to take part. The goal is to develop a quicker, less invasive tool for diagnosis, potentially reducing the need for surgery and helping women get the right treatment sooner. The study is running in several centres in Austria and Germany.

At a glance

Status

Recruiting

Sponsor

Diamens FlexCo

Enrolment target

200

Start

06 May 2026

Estimated completion

01 Dec 2029

Endometriosis

What is this study about?

Endometriosis is a condition where tissue similar to the lining of the womb grows elsewhere in the body. It can cause severe pain and other symptoms, but it often takes a long time – sometimes many years – to get a diagnosis. Currently, the most certain way to diagnose endometriosis is through a keyhole surgery called a laparoscopy, which involves general anaesthetic and a hospital stay. This can be expensive and quite a big step for patients to go through.

This study is looking into a new, much simpler way to diagnose endometriosis. Instead of surgery, it uses a lab test that checks for specific markers in a sample of menstrual blood. The aim is to see how accurate this new blood test is compared to the current surgical diagnosis. Researchers want to find out if it can correctly identify people who have endometriosis and those who don't.

Having a reliable blood test would be a huge change for people with endometriosis. It could mean getting a diagnosis much faster, without needing surgery, which would save time, reduce distress, and allow for earlier treatment. This study is hoping to prove that this new test is accurate enough to be used widely in the future, making the diagnosis process much easier for everyone affected.

Key takeaways

This study is testing a new, non-surgical blood test for endometriosis.
It aims to make diagnosis faster and easier for patients.
It involves collecting a menstrual blood sample yourself.
Participants can be women with confirmed endometriosis or healthy women.
The study hopes to reduce the need for invasive keyhole surgery.

Who may be eligible?

This study is looking for women between 14 and 49 years old who are still having their periods. They are splitting participants into groups: some will have already been diagnosed with endometriosis (either by surgery or special scans), and others will be healthy women who don't have endometriosis symptoms and whose scans show no signs of it.

You won't be able to join the study if you have stopped having periods for other reasons (like menopause), are pregnant, have cancer, or are taking certain medications for endometriosis called GnRH agonists or antagonists. These rules help make sure the study results are clear and accurate.

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 aged between 14 and 49?
Do you currently have periods?
Have you been diagnosed with endometriosis (or are you a healthy woman without symptoms)?
Are you not pregnant?
Do you not have cancer?
Are you not taking specific endometriosis medications called GnRH agonists or antagonists?

Answer every question to see your result.

What does participation involve?

If you take part, you'll be asked to collect a sample of your menstrual blood yourself. The study plans to involve about 200 women in total across multiple hospital centres, mainly in Austria and Germany. Once you've provided your sample, there won't be further visits or treatments directly for this study. The researchers will then analyse your sample in the lab. The study is expected to run for about three years in total.

Potential risks and benefits

A potential benefit of taking part is contributing to research that could lead to a much easier and quicker diagnosis for endometriosis in the future, ultimately helping many women. As this study involves self-collection of a menstrual blood sample, the risks are very low, mainly involving the minor inconvenience of collection. You are completely free to withdraw from the study at any time without giving a reason, and this will not affect any medical care you receive.

Locations (8)

Gynlounge
Verified postcode
Linz, Austria· Recruiting
Institut für Gynäkologie, Geburtshilfe und Gyn. Endokrinologie am Kepler Universitätsklinikum
Verified postcode
Linz, Austria· Recruiting
Gynäkologie und Geburtshilfe am Landesklinikum Melk
Verified postcode
Melk, Austria· Recruiting
Kinder- und Jugendgynäkologie Villa Medica Medizinisches Kompetenzzentrum GmbH
Verified postcode
Mödling, Austria· Recruiting
Wahlarztordination Puschacher
Verified postcode
Pöggstall, Austria· Recruiting
Krankenhaus der Barmherzigen Brüder Wien
Verified postcode
Vienna, Austria· Recruiting
Frauenklinik Städtisches Klinikum Karlsruhe
Verified postcode
Karlsruhe, Germany· Recruiting
Klinik für Frauenheilkunde und Geburtshilfe Barmherzige Brüder Klinik St. Hedwig
Verified postcode
Regensburg, Germany· Recruiting

Common questions

What is endometriosis?

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

Why is a new test needed?

Current diagnosis often requires surgery and can take many years. A simpler blood test could speed up diagnosis significantly.

Who is running this study?

The study is sponsored by Diamens FlexCo, a company from Austria, and involves several gynaecological centres in Austria and Germany.

Is this test available now?

No, this is a research study to validate the test. If successful, it would need further development and approval before becoming widely available.

Will I get my results from the test?

The study description doesn't specify if individual results will be shared. This is a good question to ask the study team if you consider participating.

How to find out more

Marlene Rezk-Füreder CEO

marlene@diamens.org +4367764346422 Official trial record

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