Status:
RECRUITING
Evaluating Mechanically Engineered Stem Cell Exosomes for Treating Endometrial Injury: A Clinical Study
Lead Sponsor:
Tang-Du Hospital
Collaborating Sponsors:
Xi'an Jiaotong University
Conditions:
Thin Endometrial Lining
Female Infertility
Eligibility:
FEMALE
20-40 years
Phase:
PHASE1
PHASE2
Brief Summary
The goal of this clinical trial is to evaluate if engineered mechanically umbilical cord-derived stem cell exosomes, or conventional umbilical cord -derived stem cell exosomes, can improve endometrial...
Detailed Description
This study is a prospective, non-randomized controlled clinical trial designed to evaluate the efficacy and safety of mechanically engineered umbilical cord mesenchymal stem cell-derived exosomes (ME-...
Eligibility Criteria
Inclusion
- Females aged 20-40 years (inclusive of boundary values);
- Normal ovarian reserve function (criteria: AFC ≥ 7, AMH \> 1.1 ng/mL);
- History of transcervical resection of adhesions (TCRA);
- Received PRP treatment after TCRA;
- At least one embryo transfer (ET) cycle in which they underwent standard ovarian stimulation (fresh cycle) or standard hormone replacement therapy (FET cycle), with an endometrial thickness of \<7 mm;
- Planned to continue IVF/ICSI/FET-assisted conception;
- Able to accept and adhere to treatment and follow-up and willing to sign an informed consent form.
Exclusion
- Patients with severe systemic diseases, surgical contraindications, or cycle contraindications;
- Patients with reproductive tract infections, genital tuberculosis, pelvic inflammatory disease, or malignant tumors of reproductive organs;
- Patients with systemic diseases that cause uterine bleeding;
- Patients allergic to any drugs, materials, or components used in this study;
- Patients at high risk for hormone-dependent tumors such as breast cancer or ovarian tumors;
- Patients with untreated submucosal fibroids of any size (FIGO 0/I/II), uterine fibroids ≥5 cm (FIGO III, IV, V, VI, VII), adenomyosis, unicornuate uterus, bicornuate uterus, or endometrial polyps;
- Patients with hydrosalpinx ≥3 cm or hydrosalpinx of any size with significant vaginal discharge;
- Patients with ovarian endometriotic cysts (chocolate cysts) ≥4 cm;
- Patients who participated in other clinical trials within 3 months before surgery or during the study period;
- Patients unable to tolerate anesthesia;
- Patients with genetic abnormalities;
- Other patients deemed unsuitable for participation in this study by the investigator.
Key Trial Info
Start Date :
February 21 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2027
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06896747
Start Date
February 21 2025
End Date
March 31 2027
Last Update
March 26 2025
Active Locations (2)
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1
Tang-Du Hospital
Xi'an, Shaanxi, China, 710038
2
Tang-Du Hospital
Xi'an, Shaanxi, China, 710038