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 range
20 Years – 38 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Clinical pregnancy rate
Timeframe: 90 days
Trial details
NCT IDNCT07176143
SponsorSixth Affiliated Hospital, Sun Yat-sen University
. ≥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
. Ovarian cysts ≥20 mm, submucosal/intramural uterine fibroids \>30 mm, pituitary tumors, or malignancy in any organ.