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To explore the therapeutic effect and safety of human umbilical cord mesenchymal stem cells on thin endometrial infertility and to explore whether human umbilical cord mesenchymal stem cells using collagen as the carrier can promote endometrial growth, reduce the recurrence rate of intrauterine adhesion, increase the clinical pregnancy rate, improve the pregnancy outcome, and study its safety.
This is a random, open label, and self-control experiment. 24 patients are selected and sign consent forms, then divided into two groups. Doctors collect the basic information of patient (including age, BMI, mental condition, vital sign, history of disease, pharmaco-history, and so on.), evaluate the symptom of thin endometrial infertility (menstrual conditions, uterine cavity form, pregnancies).
All patients receive laboratory and image examination as baseline. Then, cell treatment will be given based on the clinical protocol. Doctors have follow-up visit on 1, 3, 6, 12 month after treatment, and do efficacy evaluation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| stem cell and collagen transplantation group | Experimental | Human Umbilical Cord Mesenchymal Stem Cells (19#iSCLife®-UT) |
|
| control group | Active Comparator | collagen transplantation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| human umbilical cord mesenchymal stem cell complex collagen | Biological | 1 * 10^7 cells (2ml) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pregnancy outcome | Pregnancy status is tracked for pregnancy rate, clinical pregnancy rate, ongoing pregnancy rate, miscarriage rate and live birth rate. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Intrauterine adhesion patients efficacy evaluation | Evaluated by Ultrasound B. The endometrium thickness increased ≥ 2mm and "B" or "A" endometrium appeared in the endometrium proliferation stage. | 12 months |
| Irregular menstruation patients efficacy evaluation |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiangya Hospital Central South University | Changsha | Hunan | 410008 | China |
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| ID | Term |
|---|---|
| D007247 | Infertility, Female |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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randomize double-blind
| intrauterine injection | Procedure | intrauterine injection with human umbilical cord mesenchymal stem cell (19#iSCLife®-UT); total 1 time |
|
Evaluated by Menstrual Blood Volume Scale. The menstrual cycle returned to normal and menstrual volume improved. |
| 12 months |
| Poor endometrial receptivity patients efficacy evaluation | The criterion is clinical pregnancy and supplemented with ERT detection. | 12 months |
| D000091662 | Genital Diseases |
| D007246 | Infertility |