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.
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.
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.