Endometriosis
Conditions
Interventions
Test group:Polidocanol injection
Control group:Lauromacrogol injection
Sponsors
The First Medical Centre, Chinese PLA General Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. At least 18 years old; 2. According to the comprehensive judgment of clinical, imaging and laboratory examination, it was diagnosed as ovarian endometriosis with a diameter of 4-10 cm; 3. Ultrasonography revealed a single cyst in one or both ovaries with unspaced unilocular cysts; 4. Serum carbohydrate antigen 125 (CA-125) < 200 U/mL; 5. No hormones and gonadotropin-releasing hormone analogues (GnRH-a) were taken in the past three months; 6. No other gynecological diseases, serious heart and lung diseases; 7. For females of childbearing potential, pregnancy test results were negative at screening/baseline; 8. Sign informed consent voluntarily and follow protocol requirements.
Exclusion criteria
Exclusion criteria: 1. Cyst with unknown clinical diagnosis, or malignant neoplastic lesions, or cyst that disappear spontaneously. 2. Multilocular cyst; 3. CA-125 >= 200 U/mL; 4. Allergic to any component of the investigational product; 5. There are contraindications to polidocanol or lauromacrogol: patients with severe systemic disease, or severe arterial occlusive disease, or thromboembolic disease and patients at high risk of thrombosis, or immobile patients, etc.; 6. Unable to complete the puncture process; 7. There was no safe puncture path, and important organs such as major blood vessels and intestines cannot be avoided after taking auxiliary measures; 8. There are infectious lesions in the puncture path; 9. Those with severe bleeding tendency and coagulation mechanism disorder; 10. Those with a history of mental illness or neurological dysfunction; 11. Pregnant or lactating women; 12. Women who are menstruating, ovulating and/or on anticoagulant medication; 13. They are not allowed to use contraception or plan pregnancy or breastfeeding as required during the study period; 14. Other conditions that the investigator considers inappropriate to participate in the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction rate of cyst volume; | — |
Secondary
| Measure | Time frame |
|---|---|
| Cyst recurrence rate;Visual analogue scales;Quality of life;Medical costs;Duration of sclerotherapy;Total amount of sclerosing agents; | — |
Countries
China
Contacts
Public ContactLuo Yukun
The First Medical Centre, Chinese PLA General Hospital
Outcome results
None listed