hBMSC Uterine Artery Infusion for Severe IUA-Related Infertility

NCT ID: NCT07176143

Last Updated: 2025-09-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2028-12-30

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Stem cell therapy group

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.

Group Type: EXPERIMENTAL

Delivering human bone marrow mesenchymal stem cells via the uterine artery

Intervention Type: 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:

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

Control group

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: PROCEDURE

Other Intervention Names

Arterial perfusion of bone marrow mesenchymal stem cells

Eligibility Criteria

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).

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 38 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Sixth Affiliated Hospital, Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Guihua Liu

Role: CONTACT

liuguihua@mail.sysu.edu.cn

+86-15918658906

Other Identifiers

2024ZSLYFEC-013

Identifier Type: -

Identifier Source: org_study_id