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:
1. To evaluate the safety of stem cell therapy (e.g., side effects or complications). 2. To explore how stem cells help repair the endometrium (e.g., by promoting endometrial growth or improving uterine conditions).
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.
Subjects fully comprehend the screening process and study objectives, demonstrate adequate understanding of and compliance with the trial protocol, and provide signed informed consent.
Age between 20 and 38 years.
Body mass index (BMI) 18-27 kg/m².
Regular menstrual cycles (27-35 days) for ≥6 months.
Ovarian cysts ≥20 mm, submucosal/intramural uterine fibroids >30 mm, pituitary tumors, or malignancy in any organ.
Clinically significant uterine (endometrial polyps, IUA, malformations, endometriosis) or adnexal (hydrosalpinx) abnormalities.
Recurrent implantation failure (≥3 consecutive transfers with ≥6 good-quality embryos failing).
Unexplained abnormal vaginal bleeding.
Parallel
Delivering human bone marrow mesenchymal stem cells via the uterine artery
Procedure/SurgeryInterventional 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: 1. Positioning \& Anesthesia: (Patient placed in supine position; Local infiltration anesthesia administered) 2. Arterial Access: (Femoral artery punctured using Seldinger technique; Vascular sheath and catheter inserted) 3. Catheterization: (Catheter/microcatheter advanced into one uterine artery; Position confirmed by angiography) 4. Stem Cell Infusion: (Under fluoroscopic guidance, slowly inject 15mL solution containing 1×10⁶ cells/kg hBMSCs via microcatheter) 5. Postoperative Care: (Hospital observation for 48 hours) 6. Concurrent Treatment: (Hormone replacement therapy cycle maintained during the procedure month) Treatment Frequency: Single intervention
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.
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.
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.
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