hBMSC Uterine Artery Infusion for Severe IUA-Related Infertility

Inclusion criteria

• 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.

Exclusion criteria

• 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.
• Participation in other drug/device trials within 3 months prior to enrollment.
• Any condition (comorbidity, surgery, medication, or abnormal lab results) deemed by investigators to affect trial outcomes.
• Inability or refusal to comply with protocol requirements (including scheduled visits and tests).