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NCT Number: NCT02201719

Norwegian Adenomyosis Study I

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

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Key information

Conditions

Adenomyosis Dysmenorrhea Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infertility Menstruation Disturbances Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Pelvic Pain Signs and Symptoms Urogenital Diseases Uterine Diseases

Age range

25 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Department of Gynecology, Oslo University Hospital Ullevål

Oslo, 0382, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Primary outcomes

  1. Difference in sensitivity and specificity of 3D TVU and MRI; in percentage points (%)

    Time frame: within 4 weeks after 3D TVU

    Sensitivity and specificity of 3D TVU in the diagnosis of adenomyosis compared to MRI.

Secondary outcomes

  1. Positive and negative predictive value of 3D TVU in percent (%)

    Time frame: within 17 weeks after 3D TVU

    Positive and negative predictive value of 3D TVU in diagnosis of adenomyosis. The histological examination is the end-point because it is still regarded to be the gold-standard in diagnosis of adenomyosis.

  2. Difference in sensitivity and specificity of 3D TVU and 2D TVU; in percentage points (%)

    Time frame: within 17 weeks after 3D TVU

    The sensitivity and specificity of 3D TVU in the diagnosis of adenomyosis will also be compared to 2D TVU, in addition to MRI (see primary outcome measure).

  3. Difference in max. thickness of junction zone, in millimeters (mm)

    Time frame: post ovulatory in any menstruational cycle prior to surgery, within 4 weeks after 3D TVU

    Compares measurements of junction zone made by 3D TVU and MRI.

  4. Prevalence of sub- and infertility, percent (%)

    Time frame: at time of enrollment

    Questionnaire-based investigation. Prevalence of sub- and infertility in their medical history of the study population.

  5. Difference in sensitivity and specificity of 3D TVU and histopathology; in percentage points (%)

    Time frame: within 17 weeks after 3D TVU

    The sensitivity and specificity of 3D TVU in the diagnosis of adenomyosis will also be compared to 2D TVU, in addition to MRI (see primary outcome measure) and histopathology, which is still the gold standard.

  6. Prevalence of miscarriages, in percent (%)

    Time frame: at time of enrollment

    Questionnaire-based investigation. Prevalence of miscarriages in the medical history of the study population.

  7. Prevalence of previous gynecological surgeries, in percent (%)

    Time frame: at time of enrollment

    Questionnaire-based investigation. Prevalence of previous gynecological surgical interventions in the medical history of the study population.

  8. Prevalence of previous obstetrical complications, in percent (%)

    Time frame: menarche to time of enrollment

    Questionnaire-based investigation. Prevalence of previous obstetrical complications in the medical history of the study population.

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • Helse Sor-Ost

Registry information

Official study title

Norwegian Adenomyosis Study: Pathophysiology, Peristalsis, Expression Profiling and Diagnostics, Part I

Acronym: NAPPED I

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jul 28, 2014
Registry last updated
Apr 5, 2017

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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