Intrauterine AdhesionsNCT07176143
hBMSC Uterine Artery Infusion for Severe IUA-Related Infertility
A study testing Delivering human bone marrow mesenchymal stem cells via the uterine artery in people with Intrauterine Adhesions, run by Sixth Affiliated Hospital, Sun Yat-sen University.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 to 38 years, women only
- Conditions the study is for
- Intrauterine Adhesions
- What is being tested?
- Delivering human bone marrow mesenchymal stem cells via the uterine artery
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2025to 30 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 38 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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).
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- ≥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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Study on the Clinical Efficacy and Safety of Infusing Human Bone Marrow Mesenchymal Stem Cells Via Uterine Artery for the Treatment of Infertility Due to Severe Intrauterine Adhesions
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.
Read more
Secondary Objectives:
- To evaluate the safety of stem cell therapy (e.g., side effects or complications).
- 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.
- Conditions
- Intrauterine Adhesions
- Being tested
- Delivering human bone marrow mesenchymal stem cells via the uterine artery
- Keywords
- intrauterine adhesions, uterine artery perfusion, human bone marrow mesenchymal stem cells
- Medical subject headings
- Gynatresia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delivering human bone marrow mesenchymal stem cells via the uterine arteryProcedure or surgery
Also called Arterial perfusion of bone marrow mesenchymal stem cells
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:
- Positioning \& Anesthesia: (Patient placed in supine position; Local infiltration anesthesia administered)
- Arterial Access: (Femoral artery punctured using Seldinger technique; Vascular sheath and catheter inserted)
- Catheterization: (Catheter/microcatheter advanced into one uterine artery; Position confirmed by angiography)
- Stem Cell Infusion: (Under fluoroscopic guidance, slowly inject 15mL solution containing 1×10⁶ cells/kg hBMSCs via microcatheter)
- Postoperative Care: (Hospital observation for 48 hours)
- Concurrent Treatment: (Hormone replacement therapy cycle maintained during the procedure month)
Treatment Frequency: Single intervention
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days
Secondary outcomes (2)
Safety of transuterine arterial infusion of hBMSCs
Immediate adverse events include monitoring for infusion-related reactions such as fever, chills, allergic manifestations, local pain at the uterine artery puncture site or pelvis, and hemodynamic instability. Within the first week, short-term safety evaluation emphasizes detecting infection markers, thrombotic complications, and bleeding risks. Medium-term safety (1-3 months) involves assessing hepatic/renal function abnormalities, potential immune responses through autoantibody testing and lymphocyte profiling, and imaging surveillance for ectopic tissue formation. Long-term follow-up (≥6 months) systematically evaluates tumorigenic risks through serum tumor markers and pelvic imaging, screens for endometrial malignant transformation via biopsy, and monitors ovarian reserve through hormonal (FSH, AMH) and follicular tracking.
Measured: 6 month
Exploration of related mechanisms
Exploring the mechanism of endometrial proliferation in infertile subjects with severe intrauterine adhesions treated by infusion of human bone marrow mesenchymal stem cells via uterine artery.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start30 Sep 2025 (estimated)
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrauterine AdhesionsStudies of the same condition, open and under way.
- More trials run by Sixth Affiliated Hospital, Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07176143
- Sponsor's protocol ID
- 2024ZSLYFEC-013
- Status last verified
- Sep 2025
- First submitted
- 30 Jun 2025
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Clinical Efficacy and Safety of Infusing Human Bone Marrow Mesenchymal Stem Cells Via Uterine Artery for the Treatment of Infertility Due to Severe Intrauterine Adhesions
- ClinicalTrials.gov ID
- NCT07176143
- Acronym / sponsor ID
- 2024ZSLYFEC-013
- Conditions
- Intrauterine Adhesions
- Keywords
- intrauterine adhesions, uterine artery perfusion, human bone marrow mesenchymal stem cells
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 30 Sep 2025 (estimated)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 16 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To evaluate the safety of stem cell therapy (e.g., side effects or complications).
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stem cell therapy group | Experimental | Procedure: Delivering human bone marrow mesenchymal stem cells via the uterine arteryTraditional 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. |
| 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). |
Who may qualify
- Ages
- 20 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Delivering human bone marrow mesenchymal stem cells via the uterine arteryAlso: Arterial perfusion of bone marrow mesenchymal stem cellsInterventional 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 | Procedure or surgery | Stem cell therapy group |
Primary outcome
Clinical pregnancy rate
Time frame: 90 days
To assess whether stem cell therapy improves pregnancy success rates (clinical pregnancy rate after embryo transfer) in infertility patients with severe IUA undergoing IVF.
2 secondary outcomes
Safety of transuterine arterial infusion of hBMSCs
Time frame: 6 month
Exploration of related mechanisms
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Delivering human bone marrow mesenchymal stem cells via the uterine artery in people with Intrauterine Adhesions, run by Sixth Affiliated Hospital, Sun Yat-sen University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guihua Liu (+86-15918658906, liuguihua@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical pregnancy rate (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.