hBMSC Uterine Artery Infusion for Severe IUA-Related Infertility

N/ANot Yet RecruitingNCT07176143

Sixth Affiliated Hospital, Sun Yat-sen University60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Intrauterine Adhesions

Delivering human bone marrow mesenchymal stem cells via the uterine arteryPROCEDURE

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

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 38 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Subjects fully comprehend the screening process and study objectives, demonstrate adequate understanding of and compliance with the trial protocol, and provide signed informed consent. 2. Age between 20 and 38 years. 3. Body mass index (BMI) 18-27 kg/m². 4. Regular menstrual cycles (27-35 days) for ≥6 months. 5. Normal ovarian reserve: Antral follicle count (AFC) ≥6; Follicle-stimulating hormone (FSH) 1-10 IU/L on cycle days 2-4; Baseline sex hormones within normal laboratory ranges. 6. Negative serology within 6 months for: HIV antibodies; Treponema pallidum antibodies (TPA); Hepatitis B surface antigen (HBsAg); Hepatitis C virus antibodies (HCV-Ab). 7. ≥2 good-quality blastocysts (D5/D6) according to Gardner grading criteria. 8. Prior hysteroscopic diagnosis of severe intrauterine adhesions (IUA) treated with electroresection, with normal uterine cavity morphology confirmed by hysteroscopy within 3 months. 9. History of canceled frozen embryo transfers due to persistently thin endometrium (\<6 mm) in HRT and/or natural cycles during the late proliferation phase. Exclusion Criteria: 1. Ovarian cysts ≥20 mm, submucosal/intramural uterine fibroids \>30 mm, pituitary tumors, or malignancy in any organ. 2. Clinically significant uterine (endometrial polyps, IUA, malformations, endometriosis) or adnexal (hydrosalpinx) abnormalities. 3. Recurrent implantation failure (≥3 consecutive transfers with ≥6 good-quality embryos failing). 4. Unexplained abnormal vaginal bleeding. 5. Active pelvic inflammatory disease. 6. Reproductive tract malformations incompatible with pregnancy. 7. Abnormal cervical cytology (TCT) within 1 year before screening. 8. Severe hepatic/renal impairment, cardiac disease, or hypertension. 9. History of thrombophlebitis or thromboembolism. 10. Platelet count \<100×10⁹/L, hemoglobin \<100 g/L, or hematologic disorders (e.g., idiopathic thrombocytopenic purpura). 11. Clinically significant systemic diseases (e.g., diabetes, tuberculosis). 12. History of recurrent miscarriage. 13. Chromosomal abnormalities in either partner. 14. Genetic disorders (per Maternal and Infant Health Care Law) contraindicating pregnancy in either partner. 15. Exposure to teratogenic radiation, toxins, or medications in either partner. 16. Participation in other drug/device trials within 3 months prior to enrollment. 17. Any condition (comorbidity, surgery, medication, or abnormal lab results) deemed by investigators to affect trial outcomes. 18. Inability or refusal to comply with protocol requirements (including scheduled visits and tests).

Outcomes

Primary Outcomes

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.

Time frame: 90 days

Secondary Outcomes

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.

Time frame: 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.

Time frame: 1 year