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Norwegian Adenomyosis Study II: Gene Expression Profiling of Adenomyosis

NCT02197923 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2023-03-23

No results posted yet for this study

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

Interventions

PROCEDURE

Myometrial biopsy

transvaginal ultrasound guided biopsy of the myometria

PROCEDURE

endometrial biopsy

transcervical endometrial biopsy

Sponsors & Collaborators

  • University of Oslo

    collaborator OTHER

  • Helse Sor-Ost

    collaborator OTHER_GOV

  • Oslo University Hospital

    lead OTHER

Principal Investigators

  • Erik Qvigstad, PhD, MD · Oslo University Hospital, Ullevål

  • Tina Tellum, MD · Oslo University Hospital

Eligibility

Min Age
30 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-08-06
Primary Completion
2023-11-01
Completion
2024-12-01

Countries

  • Norway

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02197923 on ClinicalTrials.gov