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The purpose of the study is to evaluate the safety and effectiveness of the collagen scaffold loaded with umbilical cord derived mesenchymal stem cells (UC-MSCs) in infetile women with thin endometrium or endometrial scarring.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UC-MSCs therapy | Experimental | transplant collagen scaffold loaded with UC-MSCs to treat infertility caused by thin endometrium or endometrial scarring |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UC-MSCs therapy | Procedure | After history taking, physical examination, ultrasound examination and hysteroscopy examination,infertile women diagnosed with thin endometrium or endometrial scarring will be included in the clinical trial. A collagen scaffold loaded with UC-MSCs will be transplanted into the uterine cavity during hysteroscopy, and participants will receive hormone replacement therapy before and after the treatment. Postoperative observations including ultrasound examination once a month for 3 times and hysteroscopy in the third month after first UC-MSCs therapy. Those whose endometrium is suitable for pregnancy will be recommended attempting conception actively. The next round of cell therapy will be conducted 3 cycles after the first month if the endometrial growth is unsatisfactory. |
| Measure | Description | Time Frame |
|---|---|---|
| endometrial thickness | endometrium thickness evaluated by transvaginal sonography during late proliferating phase | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| ongoing pregnancy rate | the presence of a living intrauterine fetus on TVU at the 12th week of gestation | 24 months |
| live birth rate | a live born baby ≥28 weeks of gestation |
| Measure | Description | Time Frame |
|---|---|---|
| menstrual blood volume | the change of menstrual blood volume after surgery compared with pre-operation | baseline and 6 month postoperation |
| adverse event rate | the occurrence of infections、allergies、abdominal pain postoperation |
Inclusion Criteria:
Exclusion Criteria:
female
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| Name | Affiliation | Role |
|---|---|---|
| Yali Hu, MD,PhD | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanjing Drum Tower Hospital | Nanjing | Jiangsu | 210008 | China |
Within six months after the trial complete
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|
|
| 24 months |
| endometrial blood flow | uterine blood flow evaluated by transvaginal sonography | 6 months |
| 30 months |
| ID | Term |
|---|---|
| D007247 | Infertility, Female |
| D007246 | Infertility |
| 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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