Norwegian Adenomyosis Study I

NCT02201719 | Completed DMC

• 1 other identifier: 2014/637a
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Adenomyosis

Keywords

Adenomyosis; Dysmenorrhea; Chronic pelvic pain; Infertility; Sensitivity histology; womens health; junction zone

Outcome Measures

Primary Outcomes (1)

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

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

  within 4 weeks after 3D TVU

Secondary Outcomes (8)

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

  within 17 weeks after 3D TVU

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

  within 17 weeks after 3D TVU

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

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

• Prevalence of sub- and infertility, percent (%)

  at time of enrollment

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

  within 17 weeks after 3D TVU

Study Arms (2)

Hysterectomy Adenomyosis

Adenomyosis present

Hysterectomy no adenomyosis

Adenomyosis not present

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Oslo University Hospital: lead
• Helse Sor-Ost: collaborator

Study Sites (1)

Department of Gynecology, Oslo University Hospital Ullevål

Oslo, Oslo County, 0382, Norway

Location

Related Publications (1)

• 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.

  PMID: 30316443 DERIVED

MeSH Terms

Conditions

Adenomyosis; Dysmenorrhea; Infertility

Condition Hierarchy (Ancestors)

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

Study Officials

• Marit Lieng, PhD, MD

  Oslo University Hospital, Ullevål

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: July 2, 2014
• First Posted: July 28, 2014
• Study Start: July 1, 2014
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: April 5, 2017

Record last verified: 2017-04

Locations

NO (1)