Clinical trial NCT02197936: Norwegian Adenomyosis Study III: Peristalsis
Official title: Norwegian Adenomyosis Study: Pathophysiology, Peristalsis, Expression Profiling and Diagnostics, Part III
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Adenomyosis
Infertility
Dysmenorrhea
Keywords: Peristalsis
ultrasound
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: University of Oslo
name: Departement of Biomedical Engineering, Tel Aviv University, Tel Aviv, Israel
name: Helse Sor-Ost
First posted: 2014-07-23
Enrollment: 3
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women suffering from adenomyosis and healthy control group

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.

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

Primary outcomes:
measure: Frequency of peristaltic waves in Hz
timeFrame: five minutes
measure: Altitude of peristaltic waves in mm
timeFrame: five minutes
Secondary outcomes:
measure: direction of uterine peristalsis: antegrade, retrograde
timeFrame: 5 minutes, at time of ovulation
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Department of Gynecology, Oslo University Hospital Ullevål and Rikshospital
Study officials:
affiliation: Oslo University Hospital, Ullevål
name: Tina Tellum, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oslo University Hospital
name: Marit Lieng, PhD, MD
role: STUDY_CHAIR
References: