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hBMSC Uterine Artery Infusion for Severe IUA-Related Infertility

NCT07176143 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-09-16

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Sixth Affiliated Hospital, Sun Yat-sen University

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
38 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-30
Primary Completion
2027-12-30
Completion
2028-12-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07176143 on ClinicalTrials.gov