To compare vascular density and angiogenic factors in normal endometrium and endometrium covering submucous fibroids in patients with submucous fibroids.
ID
Source
Brief title
Condition
- Reproductive neoplasms female benign
- Menstrual cycle and uterine bleeding disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Differences in histological vascular density (based on CD34/31) in endometrium
covering fibroids versus normal endometrium.
Secondary outcome
Differenes in kwantified VEGF-A, VEGF-B, VEGF-C, FGF, Estradiol receptor,
Progesterone receptor expression, kwantified hysteroscopic vascular density
(using Narrow Band Imaging). Level of CD34/31 related ki67 expression.
The relation between endometrial vascularity index and angiogenic profile in
endometrium covering a fibroid with severity of menstrual bleeding (PBAC) and
total number of days will be assessed.
Potential prognostic parameters: age, cycle day, OC or GnRHa use, fibroid size
and level of protrusion (GIS) and vascular indices measured with 3D TV-US will
be registered.
Background summary
Submucous fibroids are an important cause of bleeding disorders in women, and
account for a substantial part of all consultations of gynaecologists. However,
the etiology of bleeding disorders caused by submucous fibroids is unknown.
Better understanding of the etiology is essential to develop more effective
therapies with fewer side effects. We hypothesize that endometrial angiogenesis
plays a key role in these bleeding disorders.
Study objective
To compare vascular density and angiogenic factors in normal endometrium and
endometrium covering submucous fibroids in patients with submucous fibroids.
Study design
A prospective cohort study
Study burden and risks
The diagnostical traject and TCRM will be performed according to the standard
used protocol. The only difference with respect the standard procedure is that
we add color-doppler to our normal performed TV-US and that during TCRM we will
collect the samples of removed endometrium and fibroid tissue separately.
Additionally we will take one extra sample of normal endometrium. The
additional risk of taking the additional endometrium samples is negligible.
Patients will be followed up by standard protocol after TCRM.
De Boelelaan 1117
1081 HV Amsterdam
NL
De Boelelaan 1117
1081 HV Amsterdam
NL
Listed location countries
Age
Inclusion criteria
Premenopausal women, aged above18 years, with a regular menstrual cycle planned for a transcervical hysteroscopic resection (TCRM) of submucous fibroids.
Exclusion criteria
Occlusion or embolization of uterine arteries in the history, risk of pelvic inflammatory disease, known endometrioses, cervical cancer or pregnancy.
Design
Recruitment
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 | NL34523.029.10 |