Actively Recruiting
Evaluating Mechanically Engineered Stem Cell Exosomes for Treating Endometrial Injury: A Clinical Study
Led by Tang-Du Hospital · Updated on 2025-03-26
90
Participants Needed
2
Research Sites
109 weeks
Total Duration
On this page
Sponsors
T
Tang-Du Hospital
Lead Sponsor
X
Xi'an Jiaotong University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 thickness in women with thin endometrium. The main questions it aims to answer are: Can exosomes delivered via subendometrial injection improve endometrial thickness or clinical pregnancy rates compared to PRP (platelet-rich plasma)? Are there significant differences in endometrial thickness between the two treatment groups? Researchers will compare the intervention groups, which one group receives mechanical exosomes and the other receives conventional esosomes via subendometrial injection, to the control group, which receives PRP via the same methods, to see if exosomes provide superior therapeutic effects. Participants will: Receive either mechanical exosomesor or conventional esosomes or PRP through subendometrial injection. Be monitored for changes in endometrial parameters.
CONDITIONS
Official Title
Evaluating Mechanically Engineered Stem Cell Exosomes for Treating Endometrial Injury: A Clinical Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 20 to 40 years (inclusive)
- Normal ovarian reserve function (AFC 63 7, AMH > 1.1 ng/mL)
- History of transcervical resection of adhesions (TCRA)
- Have received PRP treatment after TCRA
- At least one embryo transfer cycle with endometrial thickness < 7 mm
- Planning to continue IVF/ICSI/FET-assisted conception
- Able and willing to accept treatment, follow-up, and sign informed consent form
You will not qualify if you...
- Severe systemic diseases, surgical or cycle contraindications
- Reproductive tract infections, genital tuberculosis, pelvic inflammatory disease, or malignant tumors of reproductive organs
- Systemic diseases causing uterine bleeding
- Allergies to drugs, materials, or components used in the study
- High risk for hormone-dependent tumors (breast or ovarian cancer)
- Untreated submucosal fibroids (any size FIGO 0/I/II) or uterine fibroids 65 cm (FIGO III-VII), adenomyosis, unicornuate or bicornuate uterus, or endometrial polyps
- Hydrosalpinx 63 cm or hydrosalpinx with significant vaginal discharge
- Ovarian endometriotic cysts 64 cm
- Participation in other clinical trials within 3 months before surgery or during this study
- Unable to tolerate anesthesia
- Genetic abnormalities
- Other conditions deemed unsuitable by investigator
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Tang-Du Hospital
Xi'an, Shaanxi, China, 710038
Actively Recruiting
2
Tang-Du Hospital
Xi'an, Shaanxi, China, 710038
Actively Recruiting
Research Team
W
Wanlin Zhang, PhD
CONTACT
Y
Yafei Tong, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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