Intrauterine Adhesion, Thin Endometrium
Conditions
Keywords
thin endometrium, Intrauterine Adhesion, stem cell, Collagen scaffold
Brief summary
This is a non-blind self-control trial. We mainly compare the changes of endometrial thickness，changes in menstrual flow, and improvement in pregnancy before and after stem cell treatment in patients with thin endometrium.
Detailed description
According to the medical history and the results of the examination, the selected cases were screened and the informed consent was signed. After hysteroscopy, the collagen/umbilical cord mesenchymal stem cell was spread on a foley catheter, and placed in the uterine cavity, and 5 ml of saline was filled into the balloon. B-ultrasound confirmed that the stent was attached to the uterine wall. The balloon was removed in situ after 1 week. We mainly compare the endometrial thickness before and 6 months after surgery.
Interventions
DRUGumbilical cord mesenchymal stem cells combined with collagen scaffold
3-7 days after the end of menstruation, we underwent hysteroscopic exploration and separation if there was intrauterine adhesions. Intraoperative endometrial biopsy, recording biopsy location, endometrial specimens sent to HE examination and immunohistochemistry (vwf detection of microvessel density). The umbilical cord mesenchymal stem cell combined with collagen scaffold was spread on the balloon scaffold and placed in the uterine cavity. 5 ml of saline was filled into the balloon, and B-ultrasound confirmed that the scaffold was attached to the uterine wall. The patient was hospitalized for 2 hours and the patient's vital signs were recorded.
Sponsors
Sir Run Run Shaw Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
1. According to the GCP regulations, obtain the informed consent of the subject, volunteer for the test, and have signed the informed consent form. 2. Women aged 20-40 years with fertility requirements 3. Infertility patients who are treated in this hospital 4. After more than 2 times of hysteroscopic adhesion separation surgery, the uterine cavity morphology has basically returned to normal. The patient has a normal menstrual cycle or an estrogenic dose of 6 mg per day, and the highest thickness of the endometrium is 5.5 mm in 6 cycles by ultrasound. 5. or receive adjuvant reproductive treatment, the endometrial thickness is less than 5.5mm for unknown reasons, the treatment of estrogen, colony stimulating factor, aspirin, sildenafil and other drugs up to 8mg / day is invalid. 6. HBVAg negative, HCV negative, HIV negative, syphilis negative 7. Normal bone marrow morphology, normal blood routine 8. Previously failed to receive relevant stem cell therapy
Exclusion criteria
1. Those who cannot accept the treatment observation process required by the test 2. There are contraindications for hysteroscopic surgery; 3. congenital uterine malformation; severe adenomyosis; uterine fibroids that may affect embryo implantation; the investigators judged that there are other uterine factors that are not suitable for embryo implantation 4. Patients with chromosomal abnormalities 5. contraindications to estrogen therapy; systemic diseases such as thrombosis, cardiopulmonary disease, hematopoietic diseases, malignant tumors, etc. 6. Patients without fertility requirements
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the change of endometrial thickness | Change from Baseline endometrial thickness at 6 months | B-ultrasound measures and compares the endometrial thickness of the luteal phase before and after administration. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| pregnancy rate | pregnancy rate at 1 year | pregnancy rate = (pregnancy / observations) × 100% |
| live birth rate | live birth rate at 1 year | live birth rate = (live births / observations) × 100% |
| abortion rate | abortion rate at 1 year | abortion rate = (number of abortions / observations) × 100% |
Countries
China
Outcome results
None listed