Severe mechanical damage to the endometrium
Conditions
Interventions
Moderate to severe intrauterine adhesions-stem cell group:The uterine cavity was treated with human umbilical cord mesenchymal stem cell transplantation carried by cross-linked sodium hyaluronate gel
Moderate to severe intrauterine adhesions-stem cells combined with estrogen group:The uterine cavity was treated with human umbilical cord mesenchymal stem cell transplantation carried by cross-linked
Thin endometrial-stem cell group:The uterine cavity was treated with human umbilical cord mesenchymal stem cell transplantation carried by cross-linked sodium hyaluronate gel
Thin endometrial-stem cells combined with estrogen group:The uterine cavity was treated with human umbilical cord mesenchymal stem cell transplantation carried by cross-linked sodium hyaluronate gel a
Sponsors
Obstetrics and Gynecology Hospital of Fudan University
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Age 18 to 45 years old, non-menopausal, with fertility requirements; 2. History of mechanical manipulation of the uterine cavity, and the competent physician assesses the endometrial injury as mechanical injury; 3. Moderate-severe intrauterine adhesion cohort: patients who have undergone hysteroscopy and have been diagnosed with moderate (5-8 points) or severe (9-12 points) intrauterine adhesions according to the AFS intrauterine adhesion scoring criteria, and who have received ineffective traditional treatment measures in the past: have received at least one intrauterine adhesion dissection in the past, and received high-dose estrogen replacement therapy for more than 12 days after surgery (Bujiale, =4mg/day), and the intrauterine adhesion score has not been reduced by 4 points or more or the intrauterine adhesion has recurred after treatment; 4. Thin endometrial cohort: have a history of primary or secondary infertility, evaluated as endometrial causes, and evaluated by hysteroscopy without intrauterine adhesions or only mild intrauterine adhesions (AFS score 1-4), and meet any of the following conditions: (1) ultrasound on the day of hCG injection in the IVF cycle for at least 2 cycles to examine the thickness of the double intimar 1.2ng/mL on the 5th day of menstruation; 8. Regular ovulation: normal menstrual cycle; Or, patients without menstruation have demonstrated regular ovulation after at least two months of menstrual cycle B-ultrasound monitoring or basal body temperature monitoring; 9. No endometrial organic lesions: the following organic lesions were excluded by clinical, imaging evaluation, endometrial diagnosis and curettage or biopsy pathology report before treatment: mediastinal uterus, uterine fibroids, severe adenomyosis, endometriosis, endometrial cancer and precancerous lesions, cervical cancer and precancerous lesions, etc.; 10. No evidence of endometrial and systemic infectious lesions: routine vaginal secretions, endocervical secretion cultures (bacteria, chlamydia, mycoplasma), blood routine, and blood infectious indicators (CRP, PCT) were excluded before treatment.
Exclusion criteria
Exclusion criteria: 1.Those who are taking immunosuppressants or have been taking immunosuppressants in the past month; 2. Successful delivery after a previous diagnosis of moderate-severe intrauterine adhesions or thin endometrium; If the first miscarriage after pregnancy is still included in this study; 3. Those who have had serious adverse reactions to stem cell therapy in the past, and have a known history of allergy to stem cells, stem cell culture medium components, and sodium hyaluronate gel; 4. Patients with severe internal diseases, severe impairment of liver and kidney function, deep vein thrombosis, and stroke; 5. Patients with malignant tumors of other systems of the body; 6. Those who have a history of uterine surgery (excluding hysteroscopic surgery/curettage) or uterine perforation within three months; 7. Acute and subacute genital tract infection, genital tract tuberculosis, and those who have not been treated for anti-tuberculosis; Genital tract malformations. 8. Other gynecological or non-gynecological conditions, which are not suitable for pregnancy after clinical assessment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intrauterine adhesion score at the third month after initial stem cell transplantation in the moderate-severe intrauterine adhesion cohort;Intimal thickness at three months after initial stem cell transplantation in the thin endometrial cohort; | — |
Secondary
| Measure | Time frame |
|---|---|
| Effect of estrogen on the efficacy of stem cell transplantation in the treatment of endometrial injury;Intrauterine adhesion score at six months after primary stem cell transplantation in moderate-severe intrauterine adhesion cohorts;Intimal thickness at six months after primary stem cell transplantation in the thin endometrial cohort;Pregnancy rate and live birth rate after treatment;Intimal thickness at the third and six months after initial stem cell transplantation in the moderate-severe intrauterine adhesion cohort; | — |
Countries
China
Contacts
Public ContactXiaojun Chen
Obstetrics and Gynecology Hospital of Fudan University
Outcome results
None listed