Lab test that uses menstrual blood to diagnose endometriosis.
Official title: Multicenter Studie Zur Diagnostischen Validierung Eines Labortests Zur Endometriose-Diagnose
Run by Diamens FlexCo · NCT07553676 · Data updated 2026-11-12
This project will test whether a lab test using self-collected menstrual blood can accurately diagnose endometriosis in menstruating women aged 14–49.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 14 Years to 49 Years |
| Sex | Women only |
| Enrollment | 200 (estimated) |
| Sponsor | Diamens FlexCo Industry-sponsored |
| Locations | 8 sites (Linz and 7 other locations) |
| Status | Recruiting |
| Started | May 6, 2026 |
| Main results expected | December 1, 2029 |
| Study ends | December 1, 2029 |
| Registry record updated | May 11, 2026 |
| Trial ID | NCT07553676 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Menstruating women aged 14–49 who either have confirmed endometriosis or are being evaluated for endometriosis and can self-collect menstrual blood are ideal candidates.
✕Probably not a fit
People who are pregnant, have amenorrhea, have active cancer, or are taking GnRH agonists/antagonists are excluded and would not benefit from participating.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective multicenter diagnostic validation that collects self-collected menstrual blood samples from participants at several Austrian centers. A laboratory protocol will analyze biomarkers in the menstrual blood and compare results between women with histologically or imaging-confirmed endometriosis and two control groups (laparoscopy-negative and imaging-negative healthy controls). Diagnostic performance will be reported using AUC, sensitivity, specificity, PPV, NPV, LR+ and LR-. Key exclusions include pregnancy, amenorrhea, active oncologic disease, and current use of GnRH agonists or antagonists.
Why it matters
Potential benefit: If successful, this test could offer a non-invasive way to diagnose endometriosis and reduce the need for diagnostic laparoscopy.
How similar studies have gone: Some early studies of menstrual- or blood-based biomarkers have shown promise, but large multicenter validation work remains limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion criteria: * Women aged 14 to 49 * Menstruating * Endometriosis group * Histologically confirmed endometriosis * Imaging-verified endometriosis * Laparoscopy-negative group: \- Laparoscopy with no evidence of endometriosis * Imaging-negative group: * Healthy women (no symptoms of endometriosis) * Imaging shows no evidence of endometriosis Exclusion criteria: * Amenorrhea * Pregnancy * Oncological diseases * Use of GnRH agonists or antagonists
Where it's running
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Gynlounge
Linz, Austria Recruiting -
Institut für Gynäkologie, Geburtshilfe und Gyn. Endokrinologie am Kepler Universitätsklinikum
Linz, Austria Recruiting -
Gynäkologie und Geburtshilfe am Landesklinikum Melk
Melk, Austria Recruiting -
Kinder- und Jugendgynäkologie Villa Medica Medizinisches Kompetenzzentrum GmbH
Mödling, Austria Recruiting -
Wahlarztordination Puschacher
Pöggstall, Austria Recruiting -
Krankenhaus der Barmherzigen Brüder Wien
Vienna, Austria Recruiting
Show 2 more locations
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Frauenklinik Städtisches Klinikum Karlsruhe
Karlsruhe, Germany Recruiting -
Klinik für Frauenheilkunde und Geburtshilfe Barmherzige Brüder Klinik St. Hedwig
Regensburg, Germany Recruiting
Study contacts
- Study coordinator: Marlene Rezk-Füreder CEO
- Email: marlene@diamens.org
- Phone: +4367764346422
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Comparing different techniques to treat endometriosis
This study is testing different methods to treat endometriosis, like laser and heat techniques, to see which one works best for relieving pain in women who are already having surgery for the condition.
-
Postoperative Pain Trajectories After Endometriosis Surgery
This study tests how pain changes after endometriosis surgery and whether perioperative pain testing can predict who will have ongoing pain.
-
Imaging endometriosis with a special PET tracer in adult women
This study tests whether a PET/CT scan using [18F]AlF-FAPI-74 can help detect endometriosis lesions in women who are planning laparoscopy.
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Fiber supplement for digestive symptoms in endometriosis
A fiber-based supplement is being tested to see if it is safe and helps with gut and vaginal microbiomes and digestive symptoms in women with endometriosis.
-
Stellate ganglion block and dexmedetomidine for better sleep after gynecologic laparoscopy
The study tests whether giving a preoperative stellate ganglion block plus intraoperative dexmedetomidine improves sleep after laparoscopic gynecologic surgery in women.
-
Atypical Endometriosis: Histology, Immunophenotype and Molecular Features
Researchers will look at how endometriotic tissue that looks atypical under the microscope relates to clinical features and ultrasound findings to better separate benign from potentially atypical lesions.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.