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Intrauterine adhesions (IUA) is a group of diseases caused by endometrial injury leading to occlusion of the uterine cavity and serious abnormality of the uterine cavity morphology, which causes primary or secondary infertility by affecting embryo implantation. At present, the poor effectiveness of clinical treatment methods has made the thin endometrium after intrauterine adhesions an urgent problem to be solved in the clinical field of assisted reproduction.
Stem cells with multi-directional differentiation potential provide a new idea for the treatment of cervical adhesions. However, due to limitations such as stem cell extraction, technical conditions, and ethical issues, clinical application cannot be widely carried out. Exosomes are vesicle structures produced by paracrine secretion of cells, containing abundant proteins, RNA, etc., and mediating information exchange between cells. Recent studies have found that stem cells play a role in tissue repair mainly through paracrine, and stem cell-derived exosomes have similar functions to stem cells. Human cord mesenchymal stem cells were selected as an intervention for this clinical study because of their wide source, easy access, and low immunogenicity.
Therefore, in this clinical study, the investigator will evaluate the clinical safety and efficacy of infusing human umbilical cord mesenchymal stem cell exosomes into the uterine cavity for the treatment of thin endometrium after intrauterine adhesions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The conventional treatment group | Other | traditional hormone replacement therapy |
|
| Exosomes group | Experimental | Exosomes group:After hysteroscopic surgery, exosomes were infused into the uterus immediately, and traditional hormone replacement therapy (HRT) was given after surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exosmoes | Combination Product | After hysteroscopy, immediate intracavitary perfusion therapy with exosomes was administered. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Endometrial thickness | The thickness of the endometrium was measured through three-dimensional color ultrasound examination of the uterus. The thickness (in millimeters) of the endometrium before and after the hysteroscopy procedure was recorded. | One month after hysteroscopy surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical pregnancy rate | By conducting regular postoperative follow-ups on the participants, the investigator can observe their pregnancy outcomes and record whether they have successfully achieved clinical pregnancy. | 1-1.5year |
| Live birth rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| No. 26, Second Horizontal Road, Yan Village, Tianhe District | Guangzhou | Guangdong | 510600 | China |
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The conventional treatment group and Exosomes group
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| HRT | Drug | After hysteroscopy, traditional hormone replacement therapy (HRT) cycle drug treatment was performed (from the day of the surgery to the 25th day of the menstrual cycle, 3 mg of estradiol valerate (Climen) was taken twice a day, and on the 16th day of the menstrual cycle, 10 mg of dydrogesterone (Duphaston) was added twice a day for 10 days). |
|
By conducting regular postoperative follow-ups on the participates, the investigator can observe their pregnancy outcomes and record whether they have successfully achieved clinical pregnancy.
| 1-1.5year |
| 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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