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NCT Number: NCT07553676

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

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

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Key information

Conditions

Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases

Age range

14 year–49 year

Sex eligibility

Female

Study type

Observational

Primary location

Gynlounge, Linz, Austria

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

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Sponsors and collaborators

Lead sponsor

Diamens FlexCo

Industry

Collaborators

  • Kepler University Clinic, Linz

Registry information

Official study title

Multicenter Studie Zur Diagnostischen Validierung Eines Labortests Zur Endometriose-Diagnose

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Apr 28, 2026
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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