Endometrial Polyps
Conditions
Interventions
Intrauterine placement of LNG-IUS during or after the polypectomy:None
Not receive intrauterine placement of LNG-IUS during or after the polypectomy:None
Sponsors
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Eligible participants must meet all the following criteria for enrollment: 1. Able to understand and voluntarily sign the informed consent form. 2. Female. 3. Underwent hysteroscopic endometrial polypectomy due to endometrial polyps. 4. Pathological diagnosis after surgery is benign endometrial polyps. 5. The last menstrual period was within 1 year before the surgery date (only for premenopausal women). 6. Not pregnant.
Exclusion criteria
Exclusion criteria: Participants who meet any of the following criteria are ineligible for enrollment: 1. Lactating (less than 3 months from childbirth, abortion, or breastfeeding to the start of treatment). 2. Receiving long-term treatment with any category of steroid hormone medications. Women who have taken any potentially effective medications (such as estrogen or progesterone preparations, hormonal contraceptives, or hormone-releasing contraceptive devices) during the three menstrual cycles before surgery are not eligible for this study. 3. Receiving any form of hormonal therapy, including tamoxifen. 4. Having a history of malignant genital tract tumors (including vulvar cancer, vaginal cancer, cervical cancer, endometrial cancer, uterine sarcoma, fallopian tube cancer, ovarian cancer, and peritoneal mesothelioma) or breast cancer. 5. Any disease or condition that may affect the implementation of the study or the interpretation of the results, including: - Known severe coagulation disorders. - Anemia caused by reasons other than abnormal uterine bleeding (AUB). - Known hemoglobinopathies. - Presence of one or more ovarian cysts with a diameter >30 mm on ultrasound examination before enrollment, and the cystic structure on the same side of the ovary persists for more than two menstrual cycles. - Unexplained ovarian tumors or pelvic masses that require further diagnosis. - Known or suspected uterine fibroids >50 mm. 6. Alcohol, drug, or medication (e.g., psychotropic drugs) abuse. 7. Receiving other treatments that may interfere with the implementation or interpretation of the study results, including: - Gonadotropin-releasing hormone agonists (GnRH-a), if not discontinued at least 60 days before enrollment. - Use of tranexamic acid, traditional Chinese medicine, or other medications for menorrhagia, if not discontinued at enrollment. - Use of anticoagulants, if not discontinued at enrollment. 8. Having liver disease or hepatic tumors. 9. Allergic to the active ingredient or excipients. 10. Participating in another clinical trial that may affect the purpose of this study. Participation in another clinical study that could influence the objectives of this study before enrollment (before visit 1). 11. Inability to comply with the study procedures for any reason, such as: - Language comprehension barriers. - Mental illness. - Inability to visit the research center. - Poor compliance with online operations. 12. Any other reason deemed by the investigator as unsuitable for the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The recurrence rates of endometrial polyps after polypectomy;Costs related to adverse events (including drug side effects and complications), including relevant tests and treatments.; | — |
Secondary
| Measure | Time frame |
|---|---|
| The time to first recurrence of endometrial polyps and changes in patients' bleeding symptoms.;For patients with fertility desires: Time to menstrual recovery. Menstrual recovery status. Duration of bleeding. Natural conception status. Pregnancy outcomes.;Rate of secondary polypectomy;Endometrial thickness and rate of endometrial reversa for patients with endometrial hyperplasia without atypia;Overall patient satisfaction with treatment: Compliance with medication. Compliance with follow-up visits. Satisfaction with treatment. Willingness to recommend the treatment to others.;Number of outpatient visits per patient during the follow-up period.;Number of inpatient visits per patient during the follow-up period; | — |
Countries
China
Contacts
Public ContactTong Jiali, Zhu Lan
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed