Lab test that uses menstrual blood to diagnose endometriosis.
Multicenter Studie Zur Diagnostischen Validierung Eines Labortests Zur Endometriose-Diagnose
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 |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 14 Years to 49 Years |
| Sex | Female |
| Sponsor | Diamens FlexCo Industry-sponsored |
| Locations | 8 sites (Linz and 7 other locations) |
| Trial ID | NCT07553676 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Some early studies of menstrual- or blood-based biomarkers have shown promise, but large multicenter validation work remains limited.
Eligibility criteria
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 this trial is running
Linz and 7 other locations
- 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)
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.