Validation of the Adenomyosis Calculator

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.

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Key information

Conditions

Adenomyosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Pelvic Pain Syndrome Urogenital Diseases Uterine Diseases

Age range

Up to 52 year

Sex eligibility

Female

Study type

Observational

Primary location

Turku University Hospital, Turku, Finland

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Premenopausal (defined by having had menstruation the last six month)
If amenorrhea with levonorgestrel intrauterine device, the woman should be < 45 years old
Hysterectomy planned due to a benign condition
Hysterectomy does not require morcellation it is allowed to divide the uterus into 2-3 pieces, given that the orientation of the specimen is still possible for the pathologist)
Written consent is given
Can communicate in Norwegian or English at the Norwegian study sites, and Finnish, Swedish or English at the Finnish study site.

Exclusion criteria

Gynecological cancer present at the time of inclusion
Use of gonadotropin-releasing hormone agonist or antagonist within the last 3 months prior to the ultrasound evaluation
Prior endometrial ablation or resection
Postmenopausal status or no menstrual bleeding for the last 6 months, or amenorrhea with levonorgestrel-intrauterine device and age >45 years.
Need for morcellation of the uterus

Treatment and study plan

Primary outcomes

Diagnostic accuracy of the prediction model for adenomyosis

Time frame: 1 year

Diagnostic accuracy will be described using sensitivity (in %), specificity (in %), positive predictive value (in %), negative predictive value (in %), positive likelihood ratio (calculated by sensitivity/1-specificity), negative likelihood ratio (calculated as 1-sensitivity/specificity) and the area under the receiver-operator curve (as calculated with the (0-1) of the model.

Secondary outcomes

Intraclass correlation coefficient (ICC) between readers

Time frame: 2 years

ICC values are categorized as follows: 0-0.20, slight agreement; 0.21-0.40, fair agreement; 0.41-0.60, moderate agreement; 0.61-0.80, substantial agreement; and 0.81-1, almost perfect agreement

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

St. Olavs Hospital
The Hospital of Vestfold
Turku University Hospital
University Hospital, Akershus

Registry information

Official study title

Prospective Validation of a Prediction Model for Diagnosing Adenomyosis With Ultrasound.

Important dates

Study start: 2020
Primary completion: 2022
Study completion: 2022
First posted: Oct 22, 2019
Registry last updated: Dec 27, 2023

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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