Norwegian Adenomyosis Study III: Peristalsis

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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