Intrauterine Adhesion Clinical Trial
Official title:
Human Amniotic Epithelial Stem Cell in Treatment of Refractory Severe Intrauterine Adhesion
This project will investigate the safety and effectiveness of human amniotic epithelial stem cells for treatment of severe refractory Asherman's syndrome.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | September 1, 2023 |
Est. primary completion date | September 1, 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 20 Years to 45 Years |
Eligibility | Inclusion Criteria: - 1. Previously diagnosed as uterine adhesion, after the operation of TCRA and the postoperatively standardized hormonal replacement therapy(HRT) , recently diagnosed with refractory Asherman's syndrome or endometrial atrophy(EA); - 2. According to the American Fertility Society(AFS) classification in 1988, patients are diagnosed of AS or EA stage?-? confirmed by hysteroscopy; - 3. Elimination of infertility, recurrent spontaneous abortion or hypomenorrhea caused by other diseases; - 4. Be willing to maintain an HRT cycle medication throughout the study, unless it is not tolerated; - 5. Normal blood coagulation, liver, heart, and kidney function, absence of HIV, Hepatitis B or C, syphilis and psychiatric pathology; - 6. Be willing to complete the study and sign the consent form. Exclusion Criteria: - 1. Patients with severe internal disease; - 2. The patients are suffering from gynecologic inflammation or active genital tubercle bacillus; - 3. The patient has other uterine diseases or the abnormal uterine cavity which can't be restored by surgery; - 4. Infertility due to a man's cause; - 5. The patient has a previous history of cancer and is undergoing radiotherapy or chemotherapy; - 6. HIV positive - 7. Active hepatitis B or C infection, syphilis seropositive - 8. Laboratory routine check index abnormality, such as Hb(hemoglobin)<8.0 g/dL,WBC(white blood cell count)<3,000/ml, platelet counts<75 000/mm3, AST(glutamic oxalacetic transaminase)>ULN(upper limit of normal),ALT(Glutamic pyruvic transaminase)>ULN and so on; - 9. Patients have any complications that may interfere with safety or efficacy or predict life expectancy of less than 24 months; - 10. Mental illness in the past 6 months; - 11. Patients have a history of drug or alcohol abuse or dependence in the past two years; - 12. Unable or unwilling to give informed consent. |
Country | Name | City | State |
---|---|---|---|
China | Second Affiliated Hospital, School of Medicine, Zhejiang University | Hangzhou | Zhejiang |
Lead Sponsor | Collaborator |
---|---|
Second Affiliated Hospital, School of Medicine, Zhejiang University | Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | changes of Endometrial thickness | Measure the endometrial thickness during periovulatory period on ultrasound by the same trained medical sonographers at 1,3,6 and 9 months after surgery, comparing with pre-operation. | at the 1, 3,6 and 9 months after surgery | |
Primary | changes of Menstrual blood volume | Estimate the menstrual blood volume after surgery by the number of sanitary napkins per day and number of days to menstruation at 1, 3, 6, 9 months after surgery, which will be compared with pre-operation. | at the 1, 3,6 and 9 months after surgery | |
Secondary | pregnancy rate | Ultrasound reveals that the fetus had a heart activity | 24 months |
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