hBMSC Uterine Artery Infusion for Severe IUA-Related Infertility

NCT07176143 | Not Yet Recruiting

• 1 other identifier: 2024ZSLYFEC-013
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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. 1.To evaluate the safety of stem cell therapy (e.g., side effects or complications).
2. 2.To explore how stem cells help repair the endometrium (e.g., by promoting endometrial growth or improving uterine conditions).

Conditions

Intrauterine Adhesions

Keywords

intrauterine adhesions; uterine artery perfusion; human bone marrow mesenchymal stem cells

Outcome Measures

Primary Outcomes (1)

• 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.

  90 days

Secondary Outcomes (2)

• Safety of transuterine arterial infusion of hBMSCs

  6 month

• Exploration of related mechanisms

  1 year

Study Arms (2)

Stem cell therapy group

EXPERIMENTAL

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.

Procedure: Delivering human bone marrow mesenchymal stem cells via the uterine artery

Control group

NO INTERVENTION

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).

Interventions

Delivering human bone marrow mesenchymal stem cells via the uterine artery 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

Also known as: Arterial perfusion of bone marrow mesenchymal stem cells

Stem cell therapy group

Eligibility Criteria

• Age: 20 Years - 38 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.
• Negative serology within 6 months for: HIV antibodies; Treponema pallidum antibodies (TPA); Hepatitis B surface antigen (HBsAg); Hepatitis C virus antibodies (HCV-Ab).
• ≥2 good-quality blastocysts (D5/D6) according to Gardner grading criteria.
• Prior hysteroscopic diagnosis of severe intrauterine adhesions (IUA) treated with electroresection, with normal uterine cavity morphology confirmed by hysteroscopy within 3 months.
• History of canceled frozen embryo transfers due to persistently thin endometrium (\<6 mm) in HRT and/or natural cycles during the late proliferation phase.

You may not qualify if:

• 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.
• Active pelvic inflammatory disease.
• Reproductive tract malformations incompatible with pregnancy.
• Abnormal cervical cytology (TCT) within 1 year before screening.
• Severe hepatic/renal impairment, cardiac disease, or hypertension.
• History of thrombophlebitis or thromboembolism.
• Platelet count \<100×10⁹/L, hemoglobin \<100 g/L, or hematologic disorders (e.g., idiopathic thrombocytopenic purpura).
• Clinically significant systemic diseases (e.g., diabetes, tuberculosis).
• History of recurrent miscarriage.
• Chromosomal abnormalities in either partner.
• Genetic disorders (per Maternal and Infant Health Care Law) contraindicating pregnancy in either partner.
• Exposure to teratogenic radiation, toxins, or medications in either partner.

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University: lead

MeSH Terms

Conditions

Gynatresia

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

Guihua Liu

CONTACT

+86-15918658906; liuguihua@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2025
• First Posted: September 16, 2025
• Study Start: September 30, 2025
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2028
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share