A menstrual blood test for diagnosing endometriosis without surgery
Checks how well a menstrual blood test detects endometriosis in women.
Plain-language title generated from the registry record
Registry title: Multicenter Study for Diagnostic Validation of a Laboratory Test for the Diagnosis of Endometriosis
Key facts
- Where
- Linz, Melk, Mödling, Pöggstall, and Vienna, AustriaSee the 6 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 14 and 49 years old?
Source: NCT07553676, who can take part
Where in Austria
- GynloungeLinz, AustriaTaking people
- Institut für Gynäkologie, Geburtshilfe und Gyn. Endokrinologie am Kepler UniversitätsklinikumLinz, AustriaTaking people
- Gynäkologie und Geburtshilfe am Landesklinikum MelkMelk, AustriaTaking people
- Kinder- und Jugendgynäkologie Villa Medica Medizinisches Kompetenzzentrum GmbHMödling, AustriaTaking people
- Wahlarztordination PuschacherPöggstall, AustriaTaking people
- Krankenhaus der Barmherzigen Brüder WienVienna, AustriaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Diamens FlexCo
- Trial code
- NCT07553676
- Record updated
- 11 May 2026
- Original description
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 full original descriptionShow less
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.
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
Inclusion: 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: Oncological diseases; Amenorrhea; Pregnancy; Use of GnRH agonists or antagonists.