The main aim is to validate the hypothesis by Sampson on retrograde menstruation by using modern imaging modalities. •to evaluate if the amount of blood-stained peritoneal fluid measured by TVUS and MRI during menses is greater in women with…
ID
Source
Brief title
Condition
- Reproductive tract disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The amount of blood-stained peritoneal fluid measured by TVUS and MRI during
menses and during cycleday 20-22 in women with endometriosis versus healthy
controls.
Secondary outcome
- the location and the resorption of blood stained peritoneal fluid.
- the changes in volume and aspect of endometrial cysts during the menstrual
cycle.
- The molecular- biological relationship between tissue of the endometrial
cyste and the endometrium.
- Signal intensity and thickness of the junctional zone in endometriosis
patients and controls.
- Apparent diffusion coefficient (ADC) in endometrial cysts, myometrium and
junctional zone.
Background summary
Endometriosis is defined as the presence of endometrial-like tissue (which is
in normal circumstances only inside the uterus) within the pelvis and other
extra-uterine sites. It is a common estrogen dependent disease which is thought
to affect up to 10% of women of reproductive age. This can rise up to 35-50% in
women presenting with pelvic pain and infertility or both.
The etiology still remains unclear. Sampson described the theory of retrograde
menstruation in 1927. This theory describes the backflow of mentrual fluid from
the uterine cavity through the tubes to the peritoneal cavity.
In this study we will test this theory with modern imaging techniques.
Study objective
The main aim is to validate the hypothesis by Sampson on retrograde
menstruation by using modern imaging modalities.
•to evaluate if the amount of blood-stained peritoneal fluid measured by TVUS
and MRI during menses is greater in women with endometriosis versus healthy
controls.
•to evaluate the location and the resorption of blood stained peritoneal fluid
by TVUS and MRI.
•to investigate the changes in volume and aspect of endometrial cysts during
the menstrual cycle measured by TVUS and MRI.
•to investigate changes in signal intensity and thickness of the junctional
zone (JZ) during the menstrual cycle and comparing endometriosis patients and
controls by MRI.
•to investigate if diffusion in endometrial cysts, myometrium and junctional
zone changes during the cycle and in case of myometrium and the junctional
zone between endometriosis patients and controls using diffusion-weighted MRI.
Study design
In an observational, prospective case-control study 20 women diagnosed with
endometriosis through laparoscopy presenting with endometrioma are compared
with 20 controls without endometriosis.
These women will be examined on cycleday 2-4 and cycleday 20-22 by
questionnaires, gynaecological examination, transvaginal ultrasound and a MRI-
scan.
When a patient is necessary treated by cystectomie to improve her fertility, a
pipelle of the endometrioma will be taken.
Study burden and risks
The risk of this research is very little.
Transvaginal ultrasound is a very safe investigation. MRI is safe to when the
patient has no claustrophobic disease or pacemaker.
De Boelelaan 1117
Amsterdam 1081 HV
NL
De Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
- at least one patent tube (at HSG or laparoscopy with chromopertubation)
- regular menstrual cycle (28 +/- 3 days)
- cases: presence of endometriosis with uni- or bilateral ovarian endometrioma.
- controls: no presence of endometriosis confirmed by laparoscopy
- signed informed consent form
- negative pregnancy test
Exclusion criteria
- hormone therapy
- contra indications for MRI
- in controls: laparoscopy > 3 years ago
- presence of any malignancy
- frozen pelvis
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
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In other registers
| Register | ID |
|---|---|
| CCMO | NL29485.029.09 |