Endometrial polyps
Conditions
Interventions
TCRP+LNG-IUS Group:LNG-IUS placed after hysteroscope
TCRP Group:hysteroscope
Sponsors
Obstetrics and Gynecology Hospital Affiliated to Zhejiang University School of Medicine
Eligibility
Sex/Gender
Female
Age
18 Years to 46 Years
Inclusion criteria
Inclusion criteria: 1. The informed consent form has been signed and dated; 2. Female, aged at least 18 years at the time of screening, but less than 46 years, and has given birth to at least one child; 3. Endometrial polyps were diagnosed by transvaginal three-dimensional ultrasonography twice at the time of screening, and their image descriptions were consistent with ''highly echogenic mass in the uterine cavity (one of the three diameters >= 10 mm), and blood flow signals were accessible''; Bilateral endometrial thickness (excluding polyp measurements) should be <=18mm; 4. The maximum diameter of any endometrial polyp is less than 50mm; 5. Accept transcervical endometrial polypectomy (TCRP); 6. Good general health (except for conditions related to endometrial polyps) based on medical history, physical and gynecological examinations, and laboratory test results; 7. The results of cervical smear are normal or have no clinical significance, and no further follow-up is required. Pap smears may be waived if normal results are documented in the subject's medical record within the previous 6 months. Human papillomavirus (HPV) testing can be used as an adjunct test in subjects with atypical squamous cells of undetermined significance (ASCUS). Subjects with ASCUS were eligible for study entry if they tested negative for high-risk HPV strains; 8. Not pregnant, no fertility plan within two years after TCRP surgery. Use an acceptable non-hormonal method of contraception (eg, male condom, cervical cap, diaphragm, or sponge, all in combination with spermicide) from the start of the study until the end of the study. Barrier contraception is not required if permanent contraception is achieved by the subject's bilateral tubal ligation or the partner's vasectomy.
Exclusion criteria
Exclusion criteria: 1. Lactation period (delivery, miscarriage or breastfeeding less than 3 months after the start of treatment); 2. Long-term treatment with all types of steroid hormone drugs; women who received any potentially effective drugs (such as estrogen or progestin preparations, hormonal contraceptives, hormone-releasing contraceptive devices) during the first trimester before surgery are not suitable for inclusion in this study ; 3. Current users of tamoxifen; 4. Patients with malignant reproductive tract tumors (including vulvar cancer, vaginal cancer, cervical cancer, endometrial cancer, uterine sarcoma, fallopian tube cancer, ovarian cancer and peritoneal mesothelioma, etc.) or breast cancer; 5. Other contraindications for LNG-IUS placement: known or suspected pregnancy; current pelvic inflammatory disease or recurrence of pelvic inflammatory disease; lower genital tract infection; postpartum endometritis; infectious abortion within the past 3 months; cervicitis; cervical dysplasia; malignant lesions of the uterus or cervix; progesterone-dependent tumors; abnormal uterine bleeding of unknown cause; congenital or acquired uterine abnormalities, including fibroids that deform the uterine cavity; conditions that increase susceptibility to infection; acute liver disease or liver tumor; allergic to active ingredients or excipients; 6. Any disease, condition or drug that may impair the function of the body system, lead to altered absorption, excessive accumulation, metabolic impairment or altered excretion of the study drug, including but not limited to: (1) Impaired renal function (laboratory test values exceed the range of inclusion criteria); (2) Elevated liver enzymes (at least one of the following conditions exists): 1) Aspartate aminotransferase (GOT)/aspartate aminotransferase (AST) levels exceeding 2 times the upper limit of normal (ULN); 2) Alanine aminotransferase (GPT)/alanine aminotransferase (ALT) levels exceeding 2 times ULN; 3) Alkaline phosphatase (AP) level exceeds 2 times ULN; 4) Total bilirubin 1.5 times ULN; (3) Chronic intestinal diseases, such as Crohn's disease and ulcerative colitis; 7. Any disease or condition that may affect the conduct of the study or the interpretation of the results, including: (1) Known severe coagulation disorder; (2) Anemia caused by known causes other than AUB; (3) Known hemoglobinopathies; (4) Ultrasound examination before screening showed that one or more ovarian cysts were >30mm in diameter, and there were cystic structures in the same side of the ovary for more than 2 menstrual cycles; (5) Unexplained ovarian tumors or pelvic masses require further diagnosis; (6) Known or suspected uterine fibroids >50 mm; 8. Abuse of alcohol, drugs or drugs (for example, psychotropic substances); 9. Receive other treatments that may interfere with the conduct of the study or the interpretation of the results, including: (1) Gonadotropin-releasing hormone agonist (GnRHa), if not discontinued at least 60 days before enrollment; (2) Use of tranexamic acid, traditional Chinese medicine or other drugs for AUB for the treatment of menorrhagia, if not discontinued at the time of enrollment; (3) Anticoagulants are used and not stopped at the time of enrollment; 10. Participate in another drug clinical study at the same time. Participation in another clinical study that may have an impact on the purpose of this study prior to study entry (before Visit 1); 11. People closely related to the resea
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to the first recurrence of endometrial polyps; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in patient bleeding symptoms; | — |
Countries
China
Contacts
Public ContactHuang Xiufeng
Obstetrics and Gynecology Hospital Affiliated to Zhejiang University School of Medicine
Outcome results
None listed