Clinical trial NCT02201719: Norwegian Adenomyosis Study I
Official title: Norwegian Adenomyosis Study: Pathophysiology, Peristalsis, Expression Profiling and Diagnostics, Part I
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adenomyosis
Keywords: Adenomyosis
Dysmenorrhea
Chronic pelvic pain
Infertility
Sensitivity histology
womens health
junction zone
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Helse Sor-Ost
First posted: 2014-07-28
Enrollment: 100
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women referred to our clinic and volunteering to participate and that are registrated in Norway with a norwegian social security number.

Brief summary: Adenomyosis is characterized by the appearance of endometrial cells in the muscular layer of the uterus. It affects about 15-20% of the female population.

The symptoms of adenomyosis are heavy menstrual bleedings and painful menstruation (dysmenorrhea) and in addition chronic pelvic pain. Subfertility and infertility have been correlated with adenomyosis.

Parity, age and uterine abrasion increase the risk of adenomyosis. Hormonal factors such as local hyperestrogenism and elevated levels of prolactin have been identified, but autoimmune and mechanical factors are also hypothesized.

Regarding treatment, the most effective measure is hysterectomy. As this is a very drastic measure in younger women, levonogestrel-releasing intrauterine devices, Gonadotropin releasing hormone (GnRH)-analogues, Danazol, uterine embolization and endometrial ablation have been tried, but studies are few in number, retrospective, and have small sample sizes.

Adenomyosis has so far not been subject to extensive research efforts. The pathogenesis of adenomyosis remains still unclear, there are not many satisfying treatment options and diagnostics include mostly magnetic resonance imaging (MRI) and histology.

The investigators designed a series of 3 studies with a broad approach in understanding adenomyosis. This is part 1.

NAPPED-1: comparison of 3D-transvaginal ultrasound with MRI and histology in the diagnostic of adenomyosis

Detailed description: Diagnosis of Adenomyosis with 3D and 2D transvaginal ultrasound. Prospective study of a consecutive series of 101 patients that are scheduled for hysterectomy and suffer from bleeding disorders, chronic pelvic pain, dysmenorrhea or dyspareunia. All patients will undergo transvaginal 2D- ultrasound, 3D-ultrasound and power doppler (PD)-ultrasound (TVU), magnetic resonance imaging of the pelvic organs (MRI) and hysterectomy.

We will investigate the specificity and sensitivity of 3D and 2D transvaginal ultrasound in the diagnosis of adenomyosis and compare data with MRI and histopathology, which is the gold standard by today. In addition, we will collect anamnestic information that might point to risk factors or connections to prior obstetrical complications and medicine use. In our study the pathologist will not be blinded to our ultrasound findings, and we want to investigate if this will raise the sensitivity of histology findings of adenomyosis.

Eligibility criteria: Inclusion Criteria:

* Premenopausal women aged 30 - 50 years old
* scheduled for vaginal, abdominal or laparoscopic total hysterectomy
* one or more of the following clinical symptoms: bleeding disorders (menorrhagia, irregular bleeding, hypermenorrhoea), chronic pelvic pain, dysmenorrhoea, or dyspareunia
* junction zone definable

Exclusion Criteria:

* postmenopausal women,
* pregnancy
* gynecological cancer
* GnRH analog therapy or systemic hormone therapy in the last three months prior to hysterectomy
* junctional zone not identifiable

Primary outcomes:
measure: Difference in sensitivity and specificity of 3D TVU and MRI; in percentage points (%)
timeFrame: within 4 weeks after 3D TVU
Secondary outcomes:
measure: Positive and negative predictive value of 3D TVU in percent (%)
timeFrame: within 17 weeks after 3D TVU
measure: Difference in sensitivity and specificity of 3D TVU and 2D TVU; in percentage points (%)
timeFrame: within 17 weeks after 3D TVU
measure: Difference in max. thickness of junction zone, in millimeters (mm)
timeFrame: post ovulatory in any menstruational cycle prior to surgery, within 4 weeks after 3D TVU
measure: Prevalence of sub- and infertility, percent (%)
timeFrame: at time of enrollment
measure: Difference in sensitivity and specificity of 3D TVU and histopathology; in percentage points (%)
timeFrame: within 17 weeks after 3D TVU
measure: Prevalence of miscarriages, in percent (%)
timeFrame: at time of enrollment
measure: Prevalence of previous gynecological surgeries, in percent (%)
timeFrame: at time of enrollment
measure: Prevalence of previous obstetrical complications, in percent (%)
timeFrame: menarche to time of enrollment
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Department of Gynecology, Oslo University Hospital Ullevål
Study officials:
affiliation: Oslo University Hospital, Ullevål
name: Marit Lieng, PhD, MD
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.