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Norwegian Adenomyosis Study III: Peristalsis

Norwegian Adenomyosis Study: Pathophysiology, Peristalsis, Expression Profiling and Diagnostics, Part III

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02197936
Acronym
NAPPEDIII
Enrollment
3
Registered
2014-07-23
Start date
2014-07-31
Completion date
2019-01-01
Last updated
2021-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adenomyosis, Dysmenorrhea, Infertility

Keywords

Peristalsis, ultrasound

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.

Interventions

None listed

Sponsors

University of Oslo
CollaboratorOTHER
Departement of Biomedical Engineering, Tel Aviv University, Tel Aviv, Israel
CollaboratorUNKNOWN
Helse Sor-Ost
CollaboratorOTHER_GOV
Oslo University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Frequency of peristaltic waves in Hzfive minutesFrequencies of peristalsis in patients with and without adenomyosis will be compared.
Altitude of peristaltic waves in mmfive minutesThe altitude of the peristaltic waves in patients with and without adenomyosis will so be compared.

Secondary

MeasureTime frameDescription
direction of uterine peristalsis: antegrade, retrograde5 minutes, at time of ovulationDynamic motility characterization of the uterine peristalsis in women with adenomyosis.

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026