NCT07176143

hBMSC Uterine Artery Infusion for Severe IUA-Related Infertility

Study on the Clinical Efficacy and Safety of Infusing Human Bone Marrow Mesenchymal Stem Cells Via Uterine Artery for the Treatment of Infertility Due to Severe Intrauterine Adhesions

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University · Academic / Other
• Sex: Female
• Age: 20 Years – 38 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Intrauterine Adhesions

Interventions

Type	Name	Description
PROCEDURE	Delivering human bone marrow mesenchymal stem cells via the uterine artery	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: 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

Timeline

• Start date: 2025-09-30
• Primary completion: 2027-12-30
• Completion: 2028-12-30
• First posted: 2025-09-16
• Last updated: 2025-09-16