Status:
COMPLETED
Validation of the Adenomyosis Calculator
Lead Sponsor:
Oslo University Hospital
Collaborating Sponsors:
The Hospital of Vestfold
University Hospital, Akershus
Conditions:
Adenomyosis
Pelvic Pain Syndrome
Eligibility:
FEMALE
Up to 52 years
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 a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 2 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2022
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT04135118
Start Date
January 2 2020
End Date
September 1 2022
Last Update
December 27 2023
Active Locations (5)
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1
Turku University Hospital
Turku, Finland, 20521
2
Akershus University Hospital, Dept. of gynecology
Lørenskog, Akershus, Norway, 1478
3
St. Olavs Hospital, Dept. of Gynecology
Trondheim, Trøndelag, Norway, NO-7006
4
Sykehuset i Vestfold
Tønsberg, Vestfold, Norway, 3103