Clinical trial NCT04135118: Validation of the Adenomyosis Calculator
Official title: Prospective Validation of a Prediction Model for Diagnosing Adenomyosis With Ultrasound.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adenomyosis
Pelvic Pain Syndrome
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: The Hospital of Vestfold
name: University Hospital, Akershus
name: St. Olavs Hospital
name: Turku University Hospital
First posted: 2019-10-22
Enrollment: 500
Sex: FEMALE
Maximum age (years): 52
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A consecutive sample of women that are scheduled for a hysterectomy at one of the study sites and fulfill eligibility criteria are invited to participate.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Diagnostic accuracy of the prediction model for adenomyosis
timeFrame: 1 year
Secondary outcomes:
measure: Intraclass correlation coefficient (ICC) between readers
timeFrame: 2 years
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Turku University Hospital
city: Lørenskog
country: Norway
facility: Akershus University Hospital, Dept. of gynecology
state: Akershus
city: Trondheim
country: Norway
facility: St. Olavs Hospital, Dept. of Gynecology
state: Trøndelag
city: Tønsberg
country: Norway
facility: Sykehuset i Vestfold
state: Vestfold
city: Oslo
country: Norway
facility: Department of Gynecology, Oslo University Hospital Ullevål and Rikshospital
Study officials:
affiliation: Oslo University Hospital, Oslo, Norway
name: Marit Lieng, Phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tellum T, Nygaard S, Skovholt EK, Qvigstad E, Lieng M. Development of a clinical prediction model for diagnosing adenomyosis. Fertil Steril. 2018 Oct;110(5):957-964.e3. doi: 10.1016/j.fertnstert.2018.06.009.