Norwegian Adenomyosis Study III: Peristalsis

NCT ID: NCT02197936

Last Updated: 2021-03-05

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 3 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2019-01-01

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.

Conditions

Adenomyosis; Infertility; Dysmenorrhea

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Peristalsis adenomyosis

with adenomyosis

No interventions assigned to this group

Peristalsis control

No adenomyosis

No interventions assigned to this group

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Oslo

OTHER

Sponsor Role: collaborator

Departement of Biomedical Engineering, Tel Aviv University, Tel Aviv, Israel

UNKNOWN

Sponsor Role: collaborator

Helse Sor-Ost

OTHER_GOV

Sponsor Role: collaborator

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Tina Tellum

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tina Tellum, MD

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital, Ullevål

Marit Lieng, PhD, MD

Role: STUDY_CHAIR

Oslo University Hospital

Locations

Department of Gynecology, Oslo University Hospital Ullevål and Rikshospital

Oslo, , Norway

Countries

Norway

Other Identifiers

2014/637c

Identifier Type: -

Identifier Source: org_study_id