Endometrial damage
Conditions
Interventions
Experimental group:A degradable endometrial repair membrane was placed after intrauterine adhesion separation
Control group:Intrauterine cross-linked sodium hyaluronate gel +Foley balloon catheter was placed after intrauterine adhesion separation
Sponsors
Reproductive Hospital Affiliated to Shandong University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. 181.1ng/ml within 1 year); 6. Voluntarily participate in this clinical trial and sign the informed consent form of the subject.
Exclusion criteria
Exclusion criteria: 1. Acute stage of pelvic inflammatory disease and vaginal inflammation; 2. Those with a history of uterine artery embolization surgery and uterine hyman and other binding procedures; 3. Patients with malignant tumors, endometrial complex hyperplasia with or without atypical hyperplasia; 4. Patients with adenomyosis and uterus larger than 60 days of gestation or combined with submucosal muscles; 5. Patients with uterine malformations and untreated hydrosalpinx found by ultrasound; 6. Known allergic reaction to gelatin, silicone rubber, sodium hyaluronate gel or Those with contraindications; 7. Long-term oral hormone drugs or use of high doses (days) within 1 month before surgery doses greater than 8mg) on estrogen; 8. The number of platelets at the screening stage is less than 50×10^9/L or the coagulation mechanism is abnormal (APTT > 1.5 times the upper limit of normal); 9. Combined with cardiovascular and cerebrovascular diseases, abnormal liver and kidney function (ALT, AST or Cr>upper limit of normal 1.5 times), or severe illness that affects their survival (such as tumors or self-reliance patients with immune diseases, etc.; 10. Participated in the clinical trial of other interventional devices within 3 months before the start of this trial Those who have tested or participated in the last drug clinical trial within 5 half-lives; 11. Those who are considered by the investigator to be inappropriate to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effective prevention of intrauterine adhesion;Endometrial thickness changes; | — |
Secondary
| Measure | Time frame |
|---|---|
| AFS score;Uterine cavity morphology, fallopian tube opening state;menstruation;Endometrial thickness;Subendometrial blood flow classification;The number of TCRA occurrences due to re-adhesion;Instrument performance evaluation; | — |
Countries
China
Contacts
Public ContactYan Lei
Reproductive Hospital Affiliated to Shandong University
Outcome results
None listed