Norwegian Adenomyosis Study III: Peristalsis

NCT02197936 | Terminated DMC

• 1 other identifier: 2014/637c
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Adenomyosis; Infertility; Dysmenorrhea

Keywords

Peristalsis; ultrasound

Outcome Measures

Primary Outcomes (2)

• Frequency of peristaltic waves in Hz

  Frequencies of peristalsis in patients with and without adenomyosis will be compared.

  five minutes

• 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 Outcomes (1)

• direction of uterine peristalsis: antegrade, retrograde

  5 minutes, at time of ovulation

Study Arms (2)

Peristalsis adenomyosis

with adenomyosis

Peristalsis control

No adenomyosis

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women suffering from adenomyosis and healthy control group

You may qualify if:

• Premenopausal women aged 20-45 years having been diagnosed with adenomyosis earlier and have no other pathology of the uterus, regardless of clinical symptoms.

You may not qualify if:

• Postmenopausal women,
• Pregnant women,
• Gynaecological cancer,
• GnRH analog therapy or systemic hormone therapy in the last three months prior to hysterectomy,
• Endometriosis,
• Uterine fibroids

Sponsors & Collaborators

• Oslo University Hospital: lead
• University of Oslo: collaborator
• Departement of Biomedical Engineering, Tel Aviv University, Tel Aviv, Israel: collaborator
• Helse Sor-Ost: collaborator

Study Sites (1)

Department of Gynecology, Oslo University Hospital Ullevål and Rikshospital

Oslo, 0382, Norway

Location

MeSH Terms

Conditions

Adenomyosis; Infertility; Dysmenorrhea

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Tina Tellum, MD

  Oslo University Hospital, Ullevål

  PRINCIPAL INVESTIGATOR

• Marit Lieng, PhD, MD

  Oslo University Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: July 17, 2014
• First Posted: July 23, 2014
• Study Start: July 1, 2014
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: March 5, 2021

Record last verified: 2021-03

Locations

NO (1)