List of Abbreviations
GnRH-a – gonadotropin-releasing hormone agonists
AUB – abnormal uterine bleeding
DC – diagnostic curettage
COC – progestogens and estrogens (fixed combinations)
LNG-IUS – levonorgestrel-releasing intrauterine system
MHT – menopausal hormone therapy
IMB – intermenstrual bleeding
HMB – heavy menstrual bleeding
EP – endometrial polyp
SIS – sonohysterography
US – ultrasound examination
IVF – in vitro fertilization
Terms and Definitions
Endometrial polyps (EPs) are benign focal lesions of the endometrium consisting of glands, fibrotic stroma, and blood vessels [1].
Abnormal uterine bleeding (AUB) — bleeding that is excessive in duration (more than 8 days), volume of blood loss (more than 80 mL), and/or frequency (less than 24 days) [2].
Heavy menstrual bleeding (HMB) — excessive menstrual blood loss that has a negative impact on the physical, social, emotional, and/or material well-being of a woman [2].
Intermenstrual bleeding (IMB) — irregular bleeding in the intermenstrual period [2].
1. Brief information on the disease or condition
1.1 Definition of the disease or condition
Endometrial polyps (EPs) — benign focal lesions of the endometrium consisting of glands, fibrotic stroma, and blood vessels. EPs can range from a few millimeters to 2–3 cm in size, have a thin stalk or a broad base, and can be single or multiple [1, 3].
1.2 Etiology and pathogenesis of the disease or condition (group of diseases or conditions)
The etiology and pathogenesis of EPs are not precisely known. Various mechanisms for the development of EPs are considered. These include impaired expression of estrogen and progesterone receptors in the endometrium, increased activity of signaling pathways that induce proliferation and angiogenesis, and decreased apoptosis [4, 5]. EPs are also viewed as monoclonal proliferations of genetically altered endometrial stromal cells with secondary formation of glands lined by benign epithelium and having a polyclonal origin. Chromosomal analysis has shown that in most cases there are clonal translocations in the regions 6p21-p22, 12q13-15, and 7q22 2-5 [6]. In 23–27% of cases, EPs may form against the background of concomitant chronic endometritis (CE), which indicates the significance of chronic inflammation as one of the links in the pathogenesis of EPs [7, 8].
The risk of developing EPs increases from menarche to the late reproductive age and rises significantly in menopause. Risk factors for EP formation include obesity, arterial hypertension, tamoxifen therapy**, as well as prolonged cyclic menopausal hormone therapy (MHT) [3, 4, 17, 18, 9–16]. EPs are frequently associated with uterine fibroids, endometriosis, and cervical polyps [9, 10].
1.3 Epidemiology of the Disease or Condition
The prevalence of EPs ranges from 7.8% to 34.9% and tends to increase toward peri- and postmenopause [19–22]. The proportion of EPs with atypical and malignant abnormalities, according to systematic reviews and meta-analyses, is 0.3–5.4% [23–27], and it is significantly higher in postmenopause (2.3–5.4%) than in premenopause (1.1–1.7%) [23, 25, 27]. The risk of EP malignancy increases with age, reaching maximum values in postmenopause, in the presence of AUB, and with an EP size greater than 1.0–1.5 cm. Endometrial cancer is detected in 9% of postmenopausal women with EPs [27].
Obesity, diabetes mellitus (DM), arterial hypertension, and tamoxifen therapy** also increase the risk of malignancy [28–30].
The recurrence rate of EPs after surgical treatment varies from 3.9% to 59.9%, averaging about 18% [31–35]. It is believed that cases of recurrence of the disease are associated with non-radical removal of the vascular stalk of the EP [31–35].
1.4 Features of Coding the Disease or Condition
N84.0 – Polyp of corpus uteri
1.5 Classification of the disease or condition
In the classification of tumors of the uterine corpus developed by the World Health Organization (WHO), endometrial polyps (EP) are classified as tumor-like lesions without subdivision into any categories [36]. In the guide *Blaunstein’s Pathology of the Female Genital Tract*, the authors recommend distinguishing:
Endometrial polyps
Endometrial polyps with atypia [6].
Currently, a classification based on the morphological structure of EP is widely used in Russia, according to which they are subdivided into glandular, glandular-fibrous, fibrous, adenomatous, adenomyomatous, and those covered by the functional layer of the endometrium [1]. However, there is no convincing data indicating differences in clinical manifestation, recurrence rate, diagnostic features, and treatment of these EP subtypes. In addition, there are no clear morphological criteria dividing them from each other, which leads to low reproducibility of diagnoses. Accordingly, the use of this classification in clinical practice is not advisable and does not determine further management tactics [1, 6, 9, 10, 36].
1.6 Clinical presentation of the disease or condition
The most frequent clinical manifestation of EP is abnormal uterine bleeding (AUB), which is observed in 38–81.5% of cases. EP is characterized by AUB, predominantly in the form of intermenstrual bleeding (IMB), and less frequently heavy menstrual bleeding (HMB) [37–39], while the severity of symptoms does not correlate with the size, number, or location of EP [10, 40]. EP reduces the likelihood of pregnancy, which is believed to be associated with a mechanical barrier to embryo implantation, impaired endometrial receptivity, and disrupted decidualization and secretory transformation processes [4, 40–42]. The proportion of EP in the structure of infertility causes can reach 32–38.5%, while polypectomy increases the likelihood of pregnancy by more than 2 times, both during in vitro fertilization (IVF) and in a natural cycle [40, 42–44]. According to various data, from 18 to 62% of EP remain asymptomatic and are an accidental finding during ultrasound examination [37–39].
2. Diagnostics, medical indications and contraindications for diagnostic methods
The diagnosis of EP should be based on the evaluation of complaints, anamnesis data, and the conclusion of pelvic ultrasound (US) or sonohysterography (SHG). The final diagnosis of EP is confirmed by pathomorphological examination of the biopsy (surgical) endometrial material [9–11].
2.1 Complaints and Anamnesis
Complaints are described in Section 1.6. "Clinical presentation".
2.2 Physical Examination
It is recommended that all female patients with suspected EP undergo a gynecological and reproductive history taking, a physical examination according to standard propaedeutics principles, speculum examination of the cervix, and bimanual pelvic examination [11, 24, 25, 28, 30, 45]
GCR CLEL 5Grade of Recommendations C (Level of Evidence – 5)
Comments: The collection of clinical and anamnesis data is necessary to identify recurrent EP and risk factors for malignancy, which include postmenopause, EP size greater than 1.0–1.5 cm, presence of AUB, obesity, diabetes mellitus, and tamoxifen use** [24, 25, 28, 30].
2.3 Laboratory Diagnostics
Specific laboratory diagnostics for EP have not been developed.
2.4 Instrumental Diagnostics
It is recommended to perform a pelvic ultrasound (transvaginal if possible) in patients with suspected EP to establish a diagnosis [10, 20, 46–49].
GCR ALEL 1Grade of Recommendations A (Level of Evidence – 1)
Comments: Pelvic ultrasound serves as the first-line diagnostic method for endometrial pathology, including EP, which are defined as hyperechoic formations with clear, smooth margins. It is most informative when performed in the early follicular phase of the menstrual cycle. The sensitivity of ultrasound ranges from 50% to 96%, and specificity from 53% to 100% [20, 46–49]. During transvaginal ultrasound, the additional use of color Doppler mapping helps to identify with greater precision the vascular pedicle characteristic of EP. This technique increases the sensitivity of ultrasound up to 91–97% and specificity up to 95–100% [50–53].
It is recommended to perform SHG (if possible) in case of inconclusive ultrasound data and suspected EP for differential diagnosis and clarification of the diagnosis [46, 49, 54, 55].
GCR ALEL 1Grade of Recommendations A (Level of Evidence – 1)
Comments: As a clarifying diagnostic method for EP (in case of their small size or the need for differential diagnosis with submucous uterine myoma), SHG is recommended as a more accurate diagnostic method for assessing the state of the endometrium. The average sensitivity of SHG ranges from 90.7% to 100%, and specificity from 91.1% to 100%. This method is based on transvaginal ultrasound with preliminary intrauterine administration of 5–15 ml of sterile saline solution, which improves the visualization of the uterine mucosa and allows a more accurate assessment of its structural features.
It is recommended for all patients as a definitive diagnostic method to perform a pathomorphological examination of the biopsy (surgical) material [9–11, 45, 46, 56–59].
GDR CLE 5Grade of recommendation C (level of evidence – 5)
Comments: Pathomorphological examination is the definitive diagnostic method for EP, which also makes it possible to determine the presence of atypia. If EP with atypia is detected, further management is carried out in accordance with clinical guidelines for the management of atypical endometrial hyperplasia.
2.5 Other Procedures
Not applicable
3. Treatment, including drug and non-drug therapies, diet therapy, and pain management
3.1 Conservative Treatment
It is not recommended to use hormonal therapy for the treatment of EP, including progestogens (according to ATX - Progestogens), combined oral contraceptives ((COCs) – according to ATX - Progestogens and estrogens (fixed combinations)) as standalone treatment, in the pre- and postoperative period [25, 60–64].
GCR CLEL 5Grade of Recommendations C (Level of Evidence – 5)
Comments: Currently, there are no indications regarding the efficacy of medical therapy for EP. Despite the fact that progestogens and COCs lead to a decrease in endometrial thickness, EP regression is not observed, which indirectly indicates the lack of hormone dependence of EP [25, 40, 60–64]. When EP is combined with endometrial hyperplasia detected during pathomorphological examination, hormonal therapy is prescribed (see Clinical Guidelines "Endometrial Hyperplasia").
3.2 Surgical Treatment
It is recommended to perform polypectomy and endometrial biopsy in patients, including those of reproductive age with AUB, infertility, pregnancy planning, presence of malignancy risk factors, as well as in all women in the peri- and postmenopausal period, with mandatory pathomorphological examination of the biopsy (surgical) material [9, 10, 53–55, 64–70, 39, 71, 72, 40, 47–52], [73].
GCR CLEL 5Grade of Recommendations C (Level of Evidence – 5)
Comments: Polypectomy under visual control via hysteroscopy is the optimal method of treatment for EP. According to literature data, various hysteroscopic techniques have similar efficacy, including resectoscopy, diode laser, intrauterine morcellation, and the use of forceps and scissors [40].
Removal of EP stops AUB and also increases the likelihood of pregnancy in infertility by more than 2 times [40, 65, 66, 69].
It is recommended in case of recurrent EP to perform hysteroresectoscopy as a prevention of their recurrence [64, 74]
GCR CLEL 4Grade of Recommendations C (Level of Evidence – 4)
Comments: Blind curettage does not always allow complete removal of the base and vascular pedicle of the EP, which causes recurrence. The use of a hysteroresectoscope makes it possible to control the complete removal and coagulation of the EP base, which leads to a decrease in the recurrence rate [40, 64, 74].
4. Medical Rehabilitation and Sanatorium-Resort Treatment
There is no specific rehabilitation.
It is recommended for all patients to consult a physical therapy doctor to determine a rehabilitation program when EP is combined with chronic endometritis [75].
GCR CLEL 5 Grade of Recommendations C (Level of Evidence – 5)
5. Prevention and Dispensary Observation
It is not recommended routine postoperative administration of progestogens (according to ATX - Progestogens), COCs (according to ATX - Progestogens and estrogens (fixed combinations)) and antibacterial therapy in order to reduce the risk of EP recurrence [11–13].
GCR CLEL 5Grade of Recommendations C (Level of Evidence – 5)
Comments: Currently, there is no convincing data on the efficacy of drug-based methods for EP prevention.
6. Organization of Medical Care
The indication for planned hospitalization in a level 2–3 medical organization, as well as in a day hospital for surgical treatment, is the detection of EP;
The indication for emergency hospitalization in a level 1–3 medical organization is EP accompanied by acute AUB and anemia.
Indications for discharge from the medical organization:
- removal of the endometrial polyp
7. Additional Information
Patients with endometrial polyps belong to dispensary observation group 1: women with chronic conditions, benign tumors, and hyperplastic processes of the reproductive system and mammary gland, as well as benign cervical diseases
Patients with endometrial polyps belong to health group III: women who have gynecological diseases or are at risk of developing them, requiring established dispensary observation or specialized, including high-tech, medical care. For women classified under health group III, an individualized treatment program within the framework of dispensary observation is drawn up by an obstetrician-gynecologist, depending on the identified conditions [77].
Criteria for Evaluating the Quality of Medical Care
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Order of the Ministry of Health of the Russian Federation No. 1130n dated October 20, 2020, "On Approval of the Procedure for Providing Medical Care in the Field of 'Obstetrics and Gynecology.'" 2020.
Appendix A1. Working Group Composition
1. Leyla V. Adamyan – Academician of the Russian Academy of Sciences, Doctor of Medical Sciences, Professor, Deputy Director of the National Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I. Kulakov of the Ministry of Health of the Russian Federation, Honored Scientist of Russia, Head of the Department of Reproductive Medicine and Surgery at the A.I. Evdokimov Moscow State University of Medicine and Dentistry of the Ministry of Health of Russia, Chief Non-Staff Specialist in Obstetrics and Gynecology of the Ministry of Health of Russia, member of the Society for Reproductive Medicine and Surgery, the Russian Association of Endoscopic Gynecologists, the Russian Endometriosis Association, and the Russian Society of Obstetricians and Gynecologists.
2. Natalya V. Artymuk – Doctor of Medical Sciences, Professor, Head of the Professor G.A. Ushakov Department of Obstetrics and Gynecology at Kemerovo State Medical University of the Ministry of Health of Russia, Chief Non-Staff Specialist in Obstetrics and Gynecology of the Ministry of Health of Russia in the Siberian Federal District (Kemerovo), member of the Presidium of the Board of the Russian Society of Obstetricians and Gynecologists, President of the Kemerovo Regional Public Organization "Association of Obstetricians and Gynecologists."
3. Alexandra V. Asaturova – Doctor of Medical Sciences, Head of the 1st Pathological Anatomy Department at the National Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I. Kulakov of the Ministry of Health of the Russian Federation.
4. Vitaly F. Bezhenar – Doctor of Medical Sciences, Professor, Head of the Department of Obstetrics, Gynecology and Reproductology at the First Pavlov State Medical University of St. Petersburg of the Ministry of Health of Russia, Chief Non-Staff Specialist in Obstetrics and Gynecology of the Health Committee of the Government of St. Petersburg, member of the Society for Reproductive Medicine and Surgery, the Russian Association of Endoscopic Gynecologists, and the Russian Society of Obstetricians and Gynecologists.
5. Tatyana E. Belokrinitskaya – Doctor of Medical Sciences, Professor, Head of the Department of Obstetrics and Gynecology of the Faculty of Advanced Training and Professional Retraining at Chita State Medical Academy of the Ministry of Health of Russia, Honored Doctor of the Russian Federation, Chief Non-Staff Specialist in Obstetrics and Gynecology of the Ministry of Health of Russia in the Far Eastern Federal District (Chita), member of the Russian Society of Obstetricians and Gynecologists, President of the Trans-Baikal Society of Obstetricians and Gynecologists.
6. Ilya A. Ivanov – Obstetrician-Gynecologist at the Department of Gynecological Endocrinology of the National Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I. Kulakov, Candidate of Medical Sciences.
7. Apollon I. Karseladze – Professor, Doctor of Medical Sciences, Chief Researcher at the N.N. Blokhin National Medical Research Center of Oncology of the Ministry of Health of Russia, Advisor to the Director of the National Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I. Kulakov.
8. Viktoria A. Krutova – Doctor of Medical Sciences, Professor, Chief Physician of the Clinic, Vice-Rector for Clinical Work at Kuban State University of the Ministry of Health of Russia, Chief Non-Staff Specialist in Obstetrics of the Ministry of Health of Russia, Chief Non-Staff Specialist in Gynecology of the Ministry of Health of Russia, Chief Non-Staff Specialist in Women's Reproductive Health in the Southern Federal District.
9. Anna I. Malyshkina – Doctor of Medical Sciences, Professor, Director of the V.N. Gorodkov Ivanovo Research Institute of Motherhood and Childhood, Head of the Department of Obstetrics, Gynecology and Medical Genetics of the Faculty of General Medicine at Ivanovo State Medical Academy of the Ministry of Health of Russia, Chief Non-Staff Specialist in Obstetrics of the Ministry of Health of Russia, Chief Non-Staff Specialist in Gynecology of the Ministry of Health of Russia, Chief Non-Staff Specialist in Women's Reproductive Health in the Central Federal District.
10. Anna A. Olina – Doctor of Medical Sciences, Professor, Deputy Director of the Department of Medical Care for Children and Obstetrics Services of the Ministry of Health of the Russian Federation.
11. Narine M. Tonoyan – Candidate of Medical Sciences, Obstetrician-Gynecologist at the Department of Operative Gynecology of the National Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I. Kulakov of the Ministry of Health of the Russian Federation.
12. Oleg S. Filippov – Doctor of Medical Sciences, Professor at the Department of Reproductive Medicine and Surgery, A.I. Evdokimov Moscow State University of Medicine and Dentistry of the Ministry of Health of Russia (Moscow).
13. Galina E. Chernukha – Doctor of Medical Sciences, Professor, Head of the Department of Gynecological Endocrinology at the National Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I. Kulakov of the Ministry of Health of the Russian Federation, President of the Association of Gynecological Endocrinologists, member of the Russian Society of Obstetricians and Gynecologists.
14. Maria I. Yarmolinskaya – Head of the Department of Gynecology and Endocrinology at the D.O. Ott Research Institute of Obstetrics, Gynecology and Reproductology, Head of Gynecology Department No. 2, Head of the Center for Diagnosis and Treatment of Endometriosis, Professor at the Department of Obstetrics and Gynecology of the North-Western State Medical University named after I.I. Mechnikov of the Ministry of Health of Russia, Professor of the RAS, Doctor of Medical Sciences, Professor, member of the Russian Society of Obstetricians and Gynecologists.
Conflict of interest:
All members of the working group declare no conflict of interest.
Appendix A2. Methodology for Developing Clinical Guidelines
Target audience for these clinical guidelines:
1. obstetricians-gynecologists
2. students; clinical residents, postgraduate students in obstetrics and gynecology
3. educators, researchers
Table 1. Scale for assessing levels of reliable evidence (LRE) for diagnostic methods (diagnostic interventions)
LoE | Definition |
|---|---|
1 | Systematic reviews of studies with reference standard control or systematic reviews of randomized controlled trials with meta-analysis |
2 | Individual studies with reference standard control or individual randomized controlled trials and systematic reviews of studies of any design, except randomized controlled trials, with meta-analysis |
3 | Studies without consecutive reference standard control or studies with a reference standard not independent of the test method, or non-randomized comparative studies, including cohort studies |
4 | Non-comparative studies, case report |
5 | Only justification of mechanism of action or expert opinion is available |
Table 2. Scale for grading levels of evidence certainty (LEC) for prevention, treatment, and rehabilitation methods (preventive, therapeutic, and rehabilitative interventions)
LoE | Definition |
|---|---|
1 | Systematic review of RCTs with meta-analysis |
2 | Individual RCTs and systematic reviews of studies of any design except RCTs, with meta-analysis |
3 | Non-randomized comparative studies, including cohort studies |
4 | Non-comparative studies, case reports or case series, case-control studies |
5 | Only justification of the mechanism of action of the intervention (preclinical studies) or expert opinion is available |
Table 3. Scale for grading grades of recommendation (GR) for prevention, diagnostic, treatment, and rehabilitation methods (preventive, diagnostic, therapeutic, and rehabilitative interventions)
GoR | Definition |
|---|---|
A | Strong recommendation (all considered efficacy criteria (outcomes) are important, all studies are of high or acceptable methodological quality, and their conclusions on the outcomes of interest are consistent) |
B | Conditional recommendation (not all considered efficacy criteria (outcomes) are important, not all studies are of high or acceptable methodological quality, and/or their conclusions on the outcomes of interest are inconsistent) |
C | Weak recommendation (lack of adequate quality evidence (all considered efficacy criteria (outcomes) are unimportant, all studies are of low methodological quality, and their conclusions on the outcomes of interest are inconsistent) |
Procedure for updating clinical guidelines.
The mechanism for updating clinical guidelines provides for their systematic revision — at least once every three years, as well as upon the emergence of new evidence-based medicine data regarding the diagnosis, treatment, prevention, and rehabilitation of specific diseases, or in the presence of justified additions/comments to previously approved clinical guidelines, but no more frequently than once every 6 months.
Appendix A3. Reference Materials
These clinical guidelines were developed taking into account the following regulatory legal documents:
1) Order of the Russian Ministry of Health No. 1130n dated October 20, 2020, "On Approval of the Procedure for Providing Medical Care in the Profile 'Obstetrics and Gynecology'" (Registered with the Ministry of Justice of Russia on November 12, 2020, No. 60869).
Appendix B. Physician Action Algorithms
Appendix C. Patient Information
Endometrial polyps are overgrowths of the uterine mucosal lining, tear- or mushroom-shaped in appearance. Polyps can range in size from a few millimeters to 2–3 centimeters and may occur singly or in multiples within the uterine cavity. Polyps are quite common, affecting 7.8–12% of all women. They may manifest as heavy or prolonged periods, as well as spotting occurring independently of the cycle day; however, polyps are frequently asymptomatic and are an incidental finding during pelvic ultrasound examination (ultrasound). In addition, endometrial polyps interfere with pregnancy establishment. In the vast majority of cases, polyps are benign lesions. The risk of detecting atypical or cancerous cells in polyps increases with age, peaking in postmenopause, and ranges from 0.3 to 5.4%.
The causes of polyp formation are not yet fully understood. The condition is believed to be rooted in chronic inflammation, impaired molecular interactions within the endometrium, and altered uterine sensitivity to hormones. Risk factors for polyps include older age, excess weight, arterial hypertension, tamoxifen use**, and Lynch syndrome. The use of combined oral contraceptives or menopausal hormone therapy does not cause endometrial polyps to develop.
To diagnose endometrial polyps, ultrasound is used, performed immediately after menstruation ends. Sometimes polyps can be difficult to detect, especially if they are small. In such cases, the physician may order further evaluation via sonohysterography—an ultrasound with fluid instilled into the uterine cavity, which significantly increases diagnostic accuracy. However, this method is currently not widespread in Russia. A physician may also suggest diagnostic hysteroscopy, which involves examining the uterine cavity using a specialized small camera. This method serves as both diagnostics and treatment, allowing the polyp to be visualized directly and removed simultaneously.
Endometrial polyp removal is performed under anesthesia, most commonly intravenous, and takes about 15–20 minutes. Polyps can be removed using several techniques: with an electrical loop called a hysteroresectoscope, or with nonelectrical instruments. Hysteroresectoscopy is a more effective treatment method for large polyps and also reduces the recurrence rate, which averages 10 to 20%.
There are currently no medical treatments for endometrial polyps. It should be noted that therapy with progesterone preparations or combined oral contraceptives has not proven effective. Given frequent episodes of bleeding, barriers to pregnancy, and the need to prevent malignancy, removal is recommended for all women with diagnosed endometrial polyps.
Following endometrial polyp removal, pathomorphologists will examine it under a microscope and provide a histopathological report indicating whether there are signs of atypia or malignancy, as well as any other endometrial conditions. Once benign pathology is confirmed, no additional treatment is required. There is no conclusive evidence that progesterone preparations or combined oral contraceptives reduce recurrence rates. If a woman was struggling with infertility, pregnancy can be planned starting in the next menstrual cycle following polyp removal.
Further follow-up and the frequency of pelvic ultrasound examinations are determined individually by the obstetrician-gynecologist (preferably annually).
Appendix G. Assessment Scales, Questionnaires, and Other Evaluation Tools
Not applicable.