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The goal of this clinical trial is to test a new approach: delivering human bone marrow mesenchymal stem cells (hBMSCs) via the uterine artery to treat infertility caused by severe intrauterine adhesions (IUA). This method may help stem cells better reach the deep layer of the endometrium, promote endometrial repair, and improve pregnancy chances.
Primary Objective: To assess whether stem cell therapy improves pregnancy success rates (clinical pregnancy rate after embryo transfer) in infertility patients with severe IUA undergoing IVF.
Secondary Objectives:
By tracking endometrial thickness, embryo implantation rate, clinical pregnancy rate, and other indicators, we will evaluate whether this new approach is safe and effective.
Treatment Groups:
Control group: Standard hormone replacement therapy (HRT) cycle medication only.
Stem cell therapy group: Standard HRT medication + hBMSC infusion via uterine artery.
Both groups will undergo embryo transfer, and clinical pregnancy rates will be compared.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stem cell therapy group | Experimental | Traditional hormone replacement cycle therapy was used (estrogen Valerate tablets 3mg bid for 28 days, followed by Dydrogesterone tablets 10mg bid for the last 10 days of the 28 day period) + hBMSC infusion via uterine artery. |
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| Control group | No Intervention | Traditional hormone replacement cycle therapy was used (estrogen Valerate tablets 3mg bid for 28 days, followed by Dydrogesterone tablets 10mg bid for the last 10 days of the 28 day period). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Delivering human bone marrow mesenchymal stem cells via the uterine artery | Procedure | Interventional Uterine Artery Infusion of Human Bone Marrow Mesenchymal Stem Cells (hBMSCs): Subjects in the experimental group will undergo iodine allergy testing and groin area shaving/disinfection preoperatively. The procedure is performed on Day 10 of the endometrial proliferation phase. Step-by-Step Procedure:
Treatment Frequency: Single intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical pregnancy rate | To assess whether stem cell therapy improves pregnancy success rates (clinical pregnancy rate after embryo transfer) in infertility patients with severe IUA undergoing IVF. | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of transuterine arterial infusion of hBMSCs | Immediate adverse events include monitoring for infusion-related reactions such as fever, chills, allergic manifestations, local pain at the uterine artery puncture site or pelvis, and hemodynamic instability. Within the first week, short-term safety evaluation emphasizes detecting infection markers, thrombotic complications, and bleeding risks. Medium-term safety (1-3 months) involves assessing hepatic/renal function abnormalities, potential immune responses through autoantibody testing and lymphocyte profiling, and imaging surveillance for ectopic tissue formation. Long-term follow-up (≥6 months) systematically evaluates tumorigenic risks through serum tumor markers and pelvic imaging, screens for endometrial malignant transformation via biopsy, and monitors ovarian reserve through hormonal (FSH, AMH) and follicular tracking. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guihua Liu | Contact | +86-15918658906 | liuguihua@mail.sysu.edu.cn |
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| ID | Term |
|---|---|
| D006175 | Gynatresia |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| 6 month |
| Exploration of related mechanisms | Exploring the mechanism of endometrial proliferation in infertile subjects with severe intrauterine adhesions treated by infusion of human bone marrow mesenchymal stem cells via uterine artery. | 1 year |
| D000091662 | Genital Diseases |