Clinical Trial: Norwegian Adenomyosis Study III: Peristalsis

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

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 Summary:

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.


Sponsor: Oslo University Hospital

Current Primary Outcome:

  • Frequency of peristaltic waves in Hz [ Time Frame: five minutes ]
    Frequencies of peristalsis in patients with and without adenomyosis will be compared.
  • Altitude of peristaltic waves in mm [ Time Frame: five minutes ]
    The altitude of the peristaltic waves in patients with and without adenomyosis will so be compared.


Original Primary Outcome: Same as current

Current Secondary Outcome: direction of uterine peristalsis: antegrade, retrograde [ Time Frame: 5 minutes, at time of ovulation ]

Dynamic motility characterization of the uterine peristalsis in women with adenomyosis.


Original Secondary Outcome: Same as current

Information By: Oslo University Hospital

Dates:
Date Received: July 17, 2014
Date Started: July 2014
Date Completion: December 2018
Last Updated: April 4, 2017
Last Verified: April 2017