Endometrial Polyps. Pathophysiology and Clinical Consequences.
Study Part 1: New diagnostic methods for the prediction of malignancy in endometrial polyps:
A prospective pilot study.
Study of angiogenesis by identification of specific angiogenesis factors in tissue biopsies
from the endometrium and by Doppler ultrasound combined with IV contrast. We hope to find
specific characteristics with new vessel formation in the endometrial polyp, which can play
a role in the prognostic evaluation regarding the risk for cancer development. We will
compare women with endometrial polyps and women with endometrial cancer to see if these
methods of angiogenesis evaluation may be useful in separating benign polyps from
premalignant and malignant polyps.
Study Part 2: The natural history of endometrial polyps. A prospective randomised study of
patients with endometrial polyps.
Blood loss during menstruation is documented with the help of a standardized form (PBAC).
The patients are randomized to hysteroscopic resection of the endometrial polyp or 6 months
of observation. A new registration of blood loss during menstruation is performed by
patients in both groups. In the intervention group, a new gynaecological examination 6
months after the resection documents the presence of residual polyp or symptoms. The other
group is examined again after 6 months of observation. Symptoms and findings with the second
examination are compared with symptoms and findings at the first examination, any changes
are documented and the final outcome in the to groups are compared.
Study Part 3: The occurrence and natural history of asymptomatic endometrial polyps in
perimenopausal women. A prospective controlled study.
Registration of blood loss during menstruation is documented with the help of a standardized
form (PBAC) and gynaecological examination including SIS of 1000 randomly selected women in
the age group 45-50. Where endometrial polyps are identified, we document the size and
number of polyps and an endometrial biopsy is taken. After including a woman with an
endometrial polyp in the study, the next woman without endometrial polyp is recruited to the
control group. After one year, blood loss during menstruation is registered again, and all
women with endometrial polyps as well as the control group have a new examination including
vaginal ultrasound, SIS and endometrial biopsy. Symptoms and findings are compared with
symptoms and findings at the first examination and all changes are documented. If the woman
has a persistent endometrial polyp when examined at 1 year, she is offered treatment with
hysteroscopic polyp resection.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Study part 1. Angiogenesis factor levels in endometrial biopsies in patients with endometrial polyps compared to patients with endometrial cancer
Olav Istre, MD., PhD.
Department og Gynaecology, Ullevaal University Hospital, Oslo, Norway.
Norway:National Committee for Medical and Health Research Ethics