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Validation of the Adenomyosis Calculator

NCT04135118 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2023-12-27

No results posted yet for this study

Summary

Adenomyosis is a disease where ectopic endometrial glands affect the muscular wall of the uterus. Women that suffer from dysmenorrhea or infertility caused by adenomyosis need to confirm or rule out adenomyosis, and therefore tools for non-histologic confirmation of adenomyosis are indubitably required. Transvaginal ultrasound has been shown to be useful in diagnosing adenomyosis, but the interpretation of findings requires significant expertise in ultrasound and experience with diagnosing adenomyosis. This is because adenomyosis shows a very heterogeneous appearance in ultrasound. There are many different diagnostic signs that have to be considered and weighed.

In a previous study, the investigators have developed a diagnostic algorithm that helps clinicians diagnose adenomyosis with transvaginal ultrasound and a clinical examination. It showed good diagnostic accuracy and seemed to be very robust with regards to artifacts and experience of the examiner. It is now necessary to validate this prediction model in a new, prospective study so it can be used in clinical practice.

Conditions

  • Adenomyosis
  • Pelvic Pain Syndrome

Sponsors & Collaborators

  • The Hospital of Vestfold

    collaborator OTHER

  • University Hospital, Akershus

    collaborator OTHER

  • St. Olavs Hospital

    collaborator OTHER

  • Turku University Hospital

    collaborator OTHER_GOV

  • Oslo University Hospital

    lead OTHER

Principal Investigators

  • Marit Lieng, Phd · Oslo University Hospital, Oslo, Norway

Eligibility

Max Age
52 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-02
Primary Completion
2022-06-23
Completion
2022-09-01

Countries

  • Finland
  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04135118 on ClinicalTrials.gov