Infertility Clinical Trial
— NAPPEDIIIOfficial title:
Norwegian Adenomyosis Study: Pathophysiology, Peristalsis, Expression Profiling and Diagnostics, Part III
NCT number | NCT02197936 |
Other study ID # | 2014/637c |
Secondary ID | |
Status | Terminated |
Phase | |
First received | |
Last updated | |
Start date | July 2014 |
Est. completion date | January 1, 2019 |
Verified date | March 2021 |
Source | Oslo University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Norway | Department of Gynecology, Oslo University Hospital Ullevål and Rikshospital | Oslo |
Lead Sponsor | Collaborator |
---|---|
Oslo University Hospital | Departement of Biomedical Engineering, Tel Aviv University, Tel Aviv, Israel, Helse Sor-Ost, University of Oslo |
Norway,
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 |
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