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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| stem cell therapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| umbilical cord mesenchymal stem cells combined with collagen scaffold | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| the change of endometrial thickness | B-ultrasound measures and compares the endometrial thickness of the luteal phase before and after administration. | Change from Baseline endometrial thickness at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| pregnancy rate | pregnancy rate = (pregnancy / observations) × 100% | pregnancy rate at 1 year |
| live birth rate | live birth rate = (live births / observations) × 100% |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xiaona Lin | Sir Run Run Shaw Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sir Run Run Shaw hopital,School of medicine,Zhejiang University | Hangzhou | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34294152 | Derived | Zhang Y, Shi L, Lin X, Zhou F, Xin L, Xu W, Yu H, Li J, Pan M, Pan Y, Dai Y, Zhang Y, Shen J, Zhao L, Lu M, Zhang S. Unresponsive thin endometrium caused by Asherman syndrome treated with umbilical cord mesenchymal stem cells on collagen scaffolds: a pilot study. Stem Cell Res Ther. 2021 Jul 22;12(1):420. doi: 10.1186/s13287-021-02499-z. |
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|
| live birth rate at 1 year |
| abortion rate | abortion rate = (number of abortions / observations) × 100% | abortion rate at 1 year |
| ID | Term |
|---|---|
| D006175 | Gynatresia |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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