Norwegian Adenomyosis Study II: Gene Expression Profiling of Adenomyosis

NCT02197923 | Unknown DMC

• 1 other identifier: 2014/637b
• Study Type: observational
• Target: 80
• 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 (PRL) 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 2. In this study the investigators take both tissue samples and blood samples that will be investigated in order to understand the basic processes leading to adenomyosis.

Conditions

Adenomyosis

Keywords

Menorrhagia; Dysmenorrhea; Pelvic pain; expression profiling; uterine biopsies; serum hormones

Outcome Measures

Primary Outcomes (1)

• Sensitivity and specificity of biopsies for adenomyotic tissue in percent (%)

  Sensitivity and specificity of ultrasound guided myometrial biopsies for adenomyotic tissue

  At time of hysterectomy

Secondary Outcomes (8)

• multiple comparison of gene expression, measured in fold

  at time of biopsy taking

• Frequency of complications related to biopsy taking in percent (%)

  through 1 hour after biopsytaking

• Serum levels of prolactin in mU/L

  at time of hysterectomy

• Serum level of ER, in nmol/L

  at time of hysterectomy

• Serum levels of FSH in U/L

  at time of hysterectomy

Study Arms (2)

Biopsy: adenomyosis

Myometrial biopsy Pipelle

Procedure: Myometrial biopsy; Procedure: endometrial biopsy

Biopsy: Healthy

Myometrial Biopsy Pipelle

Procedure: Myometrial biopsy; Procedure: endometrial biopsy

Interventions

Myometrial biopsy PROCEDURE

transvaginal ultrasound guided biopsy of the myometria

Biopsy: Healthy; Biopsy: adenomyosis

endometrial biopsy PROCEDURE

transcervical endometrial biopsy

Also known as: Pipelle

Biopsy: Healthy; Biopsy: adenomyosis

Eligibility Criteria

• Age: 30 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

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
• University of Oslo: collaborator
• Helse Sor-Ost: collaborator

Study Sites (1)

Gynecological department, Oslo University Hospital, Ullevål

Oslo, 0382, Norway

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole blood and biopsies from uterine myometria and uterine endometria

MeSH Terms

Conditions

Adenomyosis; Menorrhagia; Dysmenorrhea; Pelvic Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Erik Qvigstad, PhD, MD

  Oslo University Hospital, Ullevål

  STUDY CHAIR

• Tina Tellum, MD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 17, 2014
• First Posted: July 23, 2014
• Study Start: August 6, 2014
• Primary Completion: November 1, 2023
• Study Completion: December 1, 2024
• Last Updated: March 23, 2023

Record last verified: 2023-03

Locations

NO (1)