Receptivity of Endometrial Tissue and Peripheral Blood Mononuclear Cells in the Pathogenetic Rationale for the Management of Postmenopause Patients With Endometrial Proliferative Processes
Conditions: Endometrial Hyperplasia Without Atypia, Endometrial Hyperplasia With Atypia, Endometrial Cancer, Peripheral Blood Mononuclear Cells, Postmenopause, Estrogen Receptor, Progesterone Receptor
Sponsor: Pirogov Russian National Research Medical University

Unique Protocol ID № 210 
Endometrial Tissues and Mononuclear Cells Receptivity in Pathogenesis of 
Endometrial Proliferative Processes 
Study protocol 
Purpose of the study 
To evaluate the role of the expression of estradiol and progesterone receptor genes in 
endometrial tissue and peripheral blood mononuclear cells in the occurrence of 
endometrial proliferative processes in postmenopausal patients with a pathogenetic 
justification for the choice of treatment method 
Research objectives 
- To determine the expression of estradiol (ERα, ERβ, mER) and progesterone 
receptor genes (PRA, PRB, mPR, PGRmC1) in endometrial tissue with hyperplasia 
without atypia, atypical hyperplasia, adenocarcinoma and endometrial polyps as a 
control group in postmenopausal patients 
- To determine the expression of estradiol and progesterone receptor genes in 
peripheral blood mononuclear cells in postmenopausal patients with polyps, atypical 
hyperplasia, endometrial adenocarcinoma and in healthy women of the same age 
(control group) 
- To compare the expression of estradiol and progesterone receptor genes in 
endometrial tissue and peripheral blood mononuclear cells in patients with 
endometrial proliferative processes, depending on the nature of the pathological 
process 
- To research the effect of progesterone and mifepristone on the receptor profile of 
peripheral blood mononuclear cells experimentally (in ex vivo conditions) 
- To develop new pathogenetic approaches to treatment endometrial proliferative 
processes in postmenopausal patients 
Research period: 2012-2022 
Duration of treatment for an individual patient: from 3 to 12 days. 
Number of patients: 90 
Inclusion criteria: 
The study included 90 postmenopausal patients with various endometrial proliferative 
processes (endometrial polyps, endometrial hyperplasia without atypia , atypical 
endometrial hyperplasia, endometrial cancer). 
Exclusion criteria were: taking hormonal drugs for 6 months before inclusion in the 
study (COC, gestagens, GnRH, MHT, tamoxifen, etc.), uterine fibroids, more than 6–

7 weeks of pregnancy, uterine appendages pathology according to pelvic ultrasound 
examination, severe extragenital pathology, inflammatory diseases of any localization 
at the time of specimen collection, and the presence of autoimmune diseases 
Design Research: 
Researchers plan to examine 90 postmenopausal patients with endometrial 
proliferative processes who are hospitalized at Hospital No. 31, Moscow, from 2012 
to 2022. 
Researchers will evaluate: 
- Assess medical data: height, weight, body mass index, activity indicator, 
gynecological history, reproductive history, family history, COC and MHT use, 
concomitant pathology. 
- Carry out standard treatment methods: hysteroscopy with dilation and curettage and 
possible simultaneous intrauterine surgery (polypectomy, electrosurgical resection of 
the endometrium in the first stages and hormonal therapy according to indications in 
the last stages. 
- To investigate the expression level of sex steroid hormone receptors genes (ER𝛼, 
ER𝛽, GPER, PRA, PRB, PGRmC1, mPR) in endometrial tissue and the peripheral 
blood mononuclear cells using RT-PCR. 
- Dynamic monitoring of patients. 
Personal data of patients will not be mentioned in work, publications, or reports. 
Side effects and additions: 
This study is safe and has minimal risk. 
01.10.2012