Norwegian Adenomyosis Study III: Peristalsis

Terminated

• Conditions: Dysmenorrhea; Adenomyosis; Infertility

• Registration Number: NCT02197936
• Lead Sponsor: Oslo University Hospital

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 Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-07-17
• Study First Submitted QC: 2014-07-22
• Study First Posted: 2014-07-23
• Primary Completion: 2019-01-01
• Study Completion: 2019-01-01
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-03
• Last Update Posted: 2021-03-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 3

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frequency of peristaltic waves in Hz	five minutes	Frequencies of peristalsis in patients with and without adenomyosis will be compared.
Altitude of peristaltic waves in mm	five minutes	The altitude of the peristaltic waves in patients with and without adenomyosis will so be compared.

Secondary Outcome Measures

Name	Time	Method
direction of uterine peristalsis: antegrade, retrograde	5 minutes, at time of ovulation	Dynamic motility characterization of the uterine peristalsis in women with adenomyosis.

Trial Locations

Locations (1)

Department of Gynecology, Oslo University Hospital Ullevål and Rikshospital; 🇳🇴 Oslo, Norway