Status:
NOT_YET_RECRUITING
hBMSC Uterine Artery Infusion for Severe IUA-Related Infertility
Lead Sponsor:
Sixth Affiliated Hospital, Sun Yat-sen University
Conditions:
Intrauterine Adhesions
Eligibility:
FEMALE
20-38 years
Phase:
NA
Brief 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 adhesi...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
September 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2028
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT07176143
Start Date
September 30 2025
End Date
December 30 2028
Last Update
September 16 2025
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