Brief Title
Norwegian Adenomyosis Study III: Peristalsis
Official Title
Norwegian Adenomyosis Study: Pathophysiology, Peristalsis, Expression Profiling and Diagnostics, Part III
Brief Summary
Spontaneous contractions (peristalsis) of the non-pregnant uterus is widely investigated and the role of correct peristalsis is most important for correct sperm transport towards the fallopian tubes and implantation of the embryo, thus obtaining pregnancy. At the same time, an impaired uterine peristalsis is discussed to be the reason for lower pregnancy rates and may also account for heavy menstrual bleedings and menstrual pain. In this study, the uterine peristalsis of women with adenomyosis will be investigated. This condition is associated to heavy menstrual bleeding, menstrual pain and infertility.
Detailed Description
The peristalsis of the non-pregnant uterus is widely investigated and the role of correct peristalsis seems to be most important for correct sperm transport towards the fallopian tubes and implantation of the embryo. At the same time, an impaired uterine peristalsis is discussed to be the reason for lower pregnancy rates and may account for dysmenorrhea and menorrhagia. The connection of impaired peristalsis and various clinical symptoms has been shown for patients with e.g. leiomyoma and endometriosis, but not for women with adenomyosis, though the concept seems to be widely accepted. It has also been repeatedly postulated that impaired peristalsis interferes with implantation of the embryo, yet Martinez-Conejero published a trial that showed a higher incidence of miscarriage, but no effect on embryo implantation in women undergoing oocyte donation. This might either indicate that the postulated effect of peristalsis is wrong or, more likely, since this is a study in an IVF setting, that hormonal treatment with gonadotropin-releasing hormone (GnRH)-agonist could improve implantation. It is possible to monitor peristalsis with transvaginal ultrasound and standard patterns of uterine peristalsis are defined by Jiland already in 1996. Findings resulting from the investigations in this study may help to determine the role and extent of impaired peristalsis in women with adenomyosis and possibly give new clues on potential treatments, as well as fill a gap in today's knowledge.
Study Type
Observational
Primary Outcome
Frequency of peristaltic waves in Hz
Secondary Outcome
direction of uterine peristalsis: antegrade, retrograde
Condition
Adenomyosis
Study Arms / Comparison Groups
Peristalsis adenomyosis
Description: with adenomyosis
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
3
Start Date
July 2014
Completion Date
January 1, 2019
Primary Completion Date
January 1, 2019
Eligibility Criteria
Inclusion Criteria: - Premenopausal women aged 20-45 years having been diagnosed with adenomyosis earlier and have no other pathology of the uterus, regardless of clinical symptoms. Exclusion Criteria: - Postmenopausal women, - Pregnant women, - Gynaecological cancer, - GnRH analog therapy or systemic hormone therapy in the last three months prior to hysterectomy, - Endometriosis, - Uterine fibroids
Gender
Female
Ages
20 Years - 45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Tina Tellum, MD, ,
Location Countries
Norway
Location Countries
Norway
Administrative Informations
NCT ID
NCT02197936
Organization ID
2014/637c
Responsible Party
Principal Investigator
Study Sponsor
Oslo University Hospital
Collaborators
University of Oslo
Study Sponsor
Tina Tellum, MD, Principal Investigator, Oslo University Hospital, Ullevål
Verification Date
March 2021