EndometriosisNCT07553676
Multicenter Study for Diagnostic Validation of a Laboratory Test for the Diagnosis of Endometriosis
An observational study of Endometriosis, run by Diamens FlexCo at 8 sites in 2 countries.
Trial summary
Endometriosis affects at least 1 in 10 women worldwide and is associated with a diagnostic delay of 5-10 years. Currently, definitive diagnosis requires invasive laparoscopy, which is costly and burdensome for patients. Read more about this study
- Who is it for?
- Ages 14 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometriosis
- How many people
- 200 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 6 May 2026to 1 Dec 2029
- How long will I take part?
- 6 Months
- Phase
- Observational
- 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 14 to 49 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Participants will be recruited at gynecology departments and affiliated outpatient clinics in Austria and Germany, including university hospitals, regional hospitals, and private gynecology practices.
Who may be able to join
- Women aged 14 to 49
- Menstruating
- Endometriosis group
- Histologically confirmed endometriosis
- Imaging-verified endometriosis
- Laparoscopy-negative group:
Show all 10Show fewer
- Laparoscopy with no evidence of endometriosis
- Imaging-negative group:
- Healthy women (no symptoms of endometriosis)
- Imaging shows no evidence of endometriosis
Who cannot join
- Amenorrhea
- Pregnancy
- Oncological diseases
- Use of GnRH agonists or antagonists
Trial locations and contacts
8 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
8 sites in 2 countries
Austria6 sites, 6 recruiting
- Recruiting
Gynlounge
Linz
Univ.-Prof. Dr. Peter Oppelt, MBA, +43732667161, gynlounge@gmx.at
- Recruiting
Institut für Gynäkologie, Geburtshilfe und Gyn. Endokrinologie am Kepler Universitätsklinikum
Linz
Dr. Simon-Hermann Enzelsberger, PhD, +43 5 7680 84, simon-hermann.enzelsberger@kepleruniklinikum.at
- Recruiting
Gynäkologie und Geburtshilfe am Landesklinikum Melk
Melk
Dr. Barbara Puschacher, +432752900421016, barbara.puschacher@melk.lknoe.at
- Recruiting
Kinder- und Jugendgynäkologie Villa Medica Medizinisches Kompetenzzentrum GmbH
Mödling
Priv.-Doz. Dr. Mateja Condic, MBA, +43 2236 866066, mateja.condic@villa-medica.at
- Recruiting
Wahlarztordination Puschacher
Pöggstall
Dr. Barbara Puschacher, +4367763080560, gyn-puschacher@gipo.at
- Recruiting
Krankenhaus der Barmherzigen Brüder Wien
Vienna, 1020
Imre Szilagyi, Prim. Dr., 01 211210, imre.szilagyi@bbwien.at
Germany2 sites, 2 recruiting
- Recruiting
Frauenklinik Städtisches Klinikum Karlsruhe
Karlsruhe
Prof. Dr. Andreas Müller, +497219742401, andreas.mueller.fk@klinikumkarslruhe.de
- Recruiting
Klinik für Frauenheilkunde und Geburtshilfe Barmherzige Brüder Klinik St. Hedwig
Regensburg
PD Prof. Dr. Mehmet Vural, +49 941 369 5201, mehmet.vural@barmherzigeregensburg.de
About this study
Official title: Multicenter Studie Zur Diagnostischen Validierung Eines Labortests Zur Endometriose-Diagnose
Endometriosis affects at least 1 in 10 women worldwide and is associated with a diagnostic delay of 5-10 years. Currently, definitive diagnosis requires invasive laparoscopy, which is costly and burdensome for patients.
This multicenter diagnostic validation study investigates a non-invasive laboratory test for the diagnosis of endometriosis based on the analysis of biomarkers from menstrual blood samples.
Read more
Study Objective:
The primary objective is to evaluate the diagnostic accuracy of a laboratory protocol for biomarker analysis from menstrual blood samples. Performance metrics including Area Under the Curve (AUC), sensitivity, specificity, negative predictive value (NPV), positive predictive value (PPV), positive likelihood ratio (LR+), and negative likelihood ratio (LR-) will be assessed by comparing women with confirmed endometriosis to confirmed controls.
Study Design:
This is a prospective multicenter diagnostic study. Menstrual blood samples are self-collected by participants.
Participants:
A total of 200 menstruating women aged 14-49 years will be enrolled across study sites. Participants are allocated to one of two cohorts.
Study Sites:
The study is conducted at multiple gynecological centers in Austria and Germany, with planned expansion to additional sites.
Sponsor: Diamens FlexCo, Linz, Austria
Expected Study Duration: 3 years
- Conditions
- Endometriosis
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Endometriosis | Menstruating women aged 14-49 years with confirmed endometriosis, either laparoscopically/histologically verified or imaging-verified (ultrasound or MRI by an expert). | |
| Controls | Laparoscopy-Negative Control Cohort: Menstruating women aged 14-49 years in whom endometriosis was excluded by laparoscopy (no visible endometriosis lesions and/or histological exclusion). Imaging-Negative Control Cohort: Healthy menstruating women aged 14-49 years without known symptoms suggestive of endometriosis, in whom endometriosis was excluded by expert ultrasound or MRI. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Accuracy of the Menstrual Blood-Based Biomarker Test for Endometriosis
Area Under the Receiver Operating Characteristic Curve (AUC-ROC) of biomarkers from menstrual blood samples.
Measured: Single self-collected menstrual blood sampling within 7 months after enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2026
- Study start6 May 2026
- Primary completion1 Dec 2029 (estimated)
- Study completion1 Dec 2029 (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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Diamens FlexCo
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kepler University Clinic, Linz
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07553676
- Sponsor's protocol ID
- 1043/2025
- Status last verified
- May 2026
- First submitted
- 19 Mar 2026
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the dataset contains highly sensitive health information from a relatively small and potentially identifiable patient population with a stigmatizing condition.
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Studie Zur Diagnostischen Validierung Eines Labortests Zur Endometriose-Diagnose
- ClinicalTrials.gov ID
- NCT07553676
- Acronym / sponsor ID
- 1043/2025
- Conditions
- Endometriosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Diamens FlexCoIndustry (pharma, biotech, devices)
- Collaborators
- Kepler University Clinic, Linz
- Study start
- 6 May 2026 (actual)
- Primary completion
- 1 Dec 2029 (estimated)
- Study completion
- 1 Dec 2029 (estimated)
- First posted
- 28 Apr 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.
Endometriosis affects at least 1 in 10 women worldwide and is associated with a diagnostic delay of 5-10 years. Currently, definitive diagnosis requires invasive laparoscopy, which is costly and burdensome for patients.
This multicenter diagnostic validation study investigates a non-invasive laboratory test for the diagnosis of endometriosis based on the analysis of biomarkers from menstrual blood samples.
Study Objective:
The primary objective is to evaluate the diagnostic accuracy of a laboratory protocol for biomarker analysis from menstrual blood samples. Performance metrics including Area Under the Curve (AUC), sensitivity, specificity, negative predictive value (NPV), positive predictive value (PPV), positive likelihood ratio (LR+), and negative likelihood ratio (LR-) will be assessed by comparing women with confirmed endometriosis to confirmed controls.
Study Design:
This is a prospective multicenter diagnostic study. Menstrual blood samples are self-collected by participants.
Participants:
A total of 200 menstruating women aged 14-49 years will be enrolled across study sites. Participants are allocated to one of two cohorts.
Study Sites:
The study is conducted at multiple gynecological centers in Austria and Germany, with planned expansion to additional sites.
Sponsor: Diamens FlexCo, Linz, Austria
Expected Study Duration: 3 years
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endometriosis | – | –Menstruating women aged 14-49 years with confirmed endometriosis, either laparoscopically/histologically verified or imaging-verified (ultrasound or MRI by an expert). |
| Controls | – | –Laparoscopy-Negative Control Cohort: Menstruating women aged 14-49 years in whom endometriosis was excluded by laparoscopy (no visible endometriosis lesions and/or histological exclusion). Imaging-Negative Control Cohort: Healthy menstruating women aged 14-49 years without known symptoms suggestive of endometriosis, in whom endometriosis was excluded by expert ultrasound or MRI. |
Who may qualify
- Ages
- 14 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Participants will be recruited at gynecology departments and affiliated outpatient clinics in Austria and Germany, including university hospitals, regional hospitals, and private gynecology practices.
Key inclusion criteria (10 listed)
- Women aged 14 to 49
- Menstruating
- Endometriosis group
- Laparoscopy-negative group:
- Imaging-negative group:
Key exclusion criteria (4 listed)
- Amenorrhea
- Pregnancy
- Oncological diseases
- Use of GnRH agonists or antagonists
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic Accuracy of the Menstrual Blood-Based Biomarker Test for Endometriosis
Time frame: Single self-collected menstrual blood sampling within 7 months after enrollment.
Area Under the Receiver Operating Characteristic Curve (AUC-ROC) of biomarkers from menstrual blood samples.
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 11 May 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the dataset contains highly sensitive health information from a relatively small and potentially identifiable patient population with a stigmatizing condition.
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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.
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis, run by Diamens FlexCo at 8 sites in 2 countries.
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 10 inclusion and 4 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 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Austria, Germany. 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 Marlene Rezk-Füreder CEO (+4367764346422, marlene@diamens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Accuracy of the Menstrual Blood-Based Biomarker Test for Endometriosis (time frame: Single self-collected menstrual blood sampling within 7 months after enrollment.). 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 11 May 2026.