Norwegian Adenomyosis Study III: Peristalsis

Infertility Clinical Trial

— NAPPEDIII  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02197936
• Other study ID #: 2014/637c
• Status: Terminated
• Start date: July 2014
• Est. completion date: January 1, 2019

Study information

• Verified date: March 2021
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: January 1, 2019
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenomyosis
• Dysmenorrhea
• Infertility

Locations

Country	Name	City	State
Norway	Department of Gynecology, Oslo University Hospital Ullevål and Rikshospital	Oslo

Sponsors (4)

Lead Sponsor	Collaborator
Oslo University Hospital	Departement of Biomedical Engineering, Tel Aviv University, Tel Aviv, Israel, Helse Sor-Ost, University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of peristaltic waves in Hz	Frequencies of peristalsis in patients with and without adenomyosis will be compared.	five minutes
Primary	Altitude of peristaltic waves in mm	The altitude of the peristaltic waves in patients with and without adenomyosis will so be compared.	five minutes
Secondary	direction of uterine peristalsis: antegrade, retrograde	Dynamic motility characterization of the uterine peristalsis in women with adenomyosis.	5 minutes, at time of ovulation