hBMSC Uterine Artery Infusion for Severe IUA-Related Infertility (NCT07176143) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
hBMSC Uterine Artery Infusion for Severe IUA-Related Infertility
60 participantsStarted 2025-09-30
Plain-language 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.
Who can participate
Age range20 Years – 38 Years
SexFEMALE
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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.
Exclusion criteria
What they're measuring
1
Clinical pregnancy rate
Timeframe: 90 days
Trial details
NCT IDNCT07176143
SponsorSixth Affiliated Hospital, Sun Yat-sen University