|- candidate number||7788|
|- NTR Number||NTR2223|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||24-feb-2010|
|- Secondary IDs||2009/329 METc VUmc |
|- Public Title||Sampsons Theory of Endometriosis tested in Amsterdam by MRI: a case- control study.
|- Scientific Title||Sampsons Theory of Endometriosis tested in Amsterdam by MRI: a case- control study.
|- hypothesis||To validate the hypothesis by Sampson on retrograde menstruation by using modern imaging modalities.|
|- Healt Condition(s) or Problem(s) studied||Endometriosis, Retrograde menstruation, Theory of Sampson|
|- Inclusion criteria||1. Female<40 years;|
3. Patent tubes (at HSG or laparoscopy with chromopertubation);
4. Regular menstrual cycle (28 days +/- 3 days);
5. Cases: presence of endometriosis confirmed by laparoscopy;
6. Controls: no presence of endometriosis confirmed by laparoscopy;
7. Signed informed consent;
8. Negative pregnancy test.
|- Exclusion criteria||1. Female age>40 years;|
2. Hormone therapy;
3. Contra indications for MR imaging (e.g.pacemaker, claustrophobia);
4. Positive pregnancy test;
5. Laparoscopy > 1 year ago;
6. Evidence of tubal occlusion seen at HSG or laparoscopy;
7. Presence of any malignancy;
8. Frozen pelvis.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-mrt-2010|
|- planned closingdate||1-jan-2013|
|- Target number of participants||40|
|- Interventions||On Cycleday 2 and Cycleday 20 a gynaecological investigation, a transvaginal ultrasound and MRI will be performed. Also a bloodsample (serum Ca 125) will be collected.
In case of a cystectomy also a pippelle from the endometrium will be taken.|
|- Primary outcome||The difference in the amount of blood-stained peritoneal fluid measured by TVUS and MRI in women with endometriosis versus healthy controls.|
|- Secondary outcome||1. The localisation and amount of resorption of blood stained peritoneal fluid;|
2. The volume and aspect of endometrial cysts;
3. Signal intesity and thickness of the junctional zone in endometriosis patients and controls;
4. Apperent Diffusion coefficient (ADC) in endometrial cysts, myometrium and junctional zone.
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| A.B. Luchinger|
|- CONTACT for SCIENTIFIC QUERIES||Dr. P.G.A. Hompes|
|- Sponsor/Initiator ||VU University Medical Center, Department of Obstetrics and Gynaecology|
(Source(s) of Monetary or Material Support)
|VU University Medical Center, Department of Obstetrics and Gynaecology|
|- Brief 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 dependant 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 remains unclear. Sampson described the theory of menstruation in 1927. This theory describes the backflow of menstrual fluid from the uterine cavity through the tubes to the peritoneal cavity. In this study we will test this theory with modern imaging techniques (TVUS and MRI).|
|- Main changes (audit trail)|
|- RECORD||24-feb-2010 - 12-mrt-2010|