Norwegian Adenomyosis Study I

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Brief Title

Norwegian Adenomyosis Study I

Official Title

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

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.
    


Study Type

Observational


Primary Outcome

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

Secondary Outcome

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

Condition

Adenomyosis


Study Arms / Comparison Groups

 Hysterectomy Adenomyosis
Description:  Adenomyosis present

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

100

Start Date

July 2014

Completion Date

January 2017

Primary Completion Date

January 2017

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
      

Gender

Female

Ages

25 Years - 50 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Marit Lieng, PhD, MD, , 

Location Countries

Norway

Location Countries

Norway

Administrative Informations


NCT ID

NCT02201719

Organization ID

2014/637a


Responsible Party

Principal Investigator

Study Sponsor

Oslo University Hospital

Collaborators

 Helse Sor-Ost

Study Sponsor

Marit Lieng, PhD, MD, Principal Investigator, Oslo University Hospital, Ullevål


Verification Date

April 2017