Validation of the Adenomyosis Calculator

  • STATUS
    Recruiting
  • days left to enroll
    85
  • participants needed
    500
  • sponsor
    Oslo University Hospital
Updated on 23 January 2021
hysterectomy
levonorgestrel
dysmenorrhea
infertility
transvaginal ultrasound
adenomyosis

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.

Details
Condition Disorder of uterus NOS, Uterine Disorders, Endometriosis, Endometriosis, Pelvic Pain Syndrome, Pelvic Congestion Syndrome, Uterine Disorders, adenomyosis
Clinical Study IdentifierNCT04135118
SponsorOslo University Hospital
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

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
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