Main objective of this study is describing the functional morphology of the microcirculation of the endometrium.
ID
Source
Brief title
Condition
- Menstrual cycle and uterine bleeding disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Measurement of microcirculatory parameters of the endometrium using orthogonal
polarization spectral (OPS).
Secondary outcome
Identifying whether the findings on the microcirculatory architecture and
capillary density of the endometrium can be linked to clinical symptoms.
Background summary
The aetiology of abnormal uterine bleeding is poorly understood. The
endometrium is the mucous lining of the cavity of the uterus, which, in
response to hormones from the ovaries, builds up during the menstrual cycle
and, in absence of conception, is shed. This shedding of the endometrium is
what constitutes the menstruation. Little is known about the contribution to
abnormal blood loss by the endometrium itself. The vascularisation and
microcirculation of the endometrium might play an important role in the
causation of abnormal uterine bleeding. In order to be able to study the
endometrium as a possible cause of abnormal bleeding, firstly it is necessary
to be informed about the feasibility of studying the microcirculation of the
endometrium in a reproducible manner. To date, no in vivo study of the
functional morphology of the microcirculation of the endometrium has been
reported.
The aim of this study is to investigate the use of the orthogonal polarization
spectral (OPS) imaging modes for evaluation of the microcirculation of the
endometrium.
Study objective
Main objective of this study is describing the functional morphology of the
microcirculation of the endometrium.
Study design
Observational pilot study.
Study burden and risks
One burden of this study consists of the consultation in which the patient is
informed about and counselled for this study. This will take place in the
outpatient clinic, and will approximately add an extra 20 minutes to their
clinic visit, when they are being planned to have a hysterectomy, TCRM or
diagnostic hysteroscopy. Another burden will be the procedure of the actual
investigation of the endometrium using the orthogonal polarization spectral
(OPS) imaging device. The risk associated with this investigation is the risk
of perforation of the uterine wall. This is a small risk, consistent with the
risk of perforation during conventional hysteroscopy, and is estimated to be
around 1:1000.
For the study subject, there are no benefits in participating in this study
Meibergdreef 9 9
Amsterdam 1105 AZ
NL
Meibergdreef 9 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Patients scheduled for hysterectomy, transcervical fibroid resection or diagnostic hysteroscopy for benign condition.
Exclusion criteria
Presence or suspicion of (pre-)malignant condition of endometrium, uterus and/or cervix.
Stenosis of cervix/cervical canal.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL53160.018.16 |