Evaluating Mechanically Engineered Stem Cell Exosomes for Treating Endometrial Injury: a Clinical Study

Launched by TANG-DU HOSPITAL · Mar 19, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment for women who have a thin endometrial lining, which can affect fertility. The study is specifically looking at whether specially engineered stem cell exosomes, derived from umbilical cords, can help increase the thickness of the endometrium compared to traditional stem cell exosomes and a common treatment called platelet-rich plasma (PRP). By injecting these treatments directly into the endometrium, the researchers hope to see if one method is more effective than the others in improving endometrial thickness and increasing the chances of pregnancy.

To participate in this trial, women aged 20-40 who have had previous treatments for intrauterine adhesions and have a history of challenges with fertility may be eligible. Participants will receive one of the three treatments—mechanically engineered exosomes, conventional exosomes, or PRP—and will be monitored for changes in their endometrial health. It’s important for potential participants to be in good overall health and willing to follow the study's guidelines. If you think you might qualify and are interested in joining, you'll need to talk to your doctor about the details and get informed consent.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Females aged 20-40 years (inclusive of boundary values);
• • 2. Normal ovarian reserve function (criteria: AFC ≥ 7, AMH \> 1.1 ng/mL);
• • 3. History of transcervical resection of adhesions (TCRA);
• • 4. Received PRP treatment after TCRA;
• • 5. 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;
• • 6. Planned to continue IVF/ICSI/FET-assisted conception;
• • 7. Able to accept and adhere to treatment and follow-up and willing to sign an informed consent form.
• Exclusion Criteria:
• • 1. Patients with severe systemic diseases, surgical contraindications, or cycle contraindications;
• • 2. Patients with reproductive tract infections, genital tuberculosis, pelvic inflammatory disease, or malignant tumors of reproductive organs;
• • 3. Patients with systemic diseases that cause uterine bleeding;
• • 4. Patients allergic to any drugs, materials, or components used in this study;
• • 5. Patients at high risk for hormone-dependent tumors such as breast cancer or ovarian tumors;
• • 6. 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;
• • 7. Patients with hydrosalpinx ≥3 cm or hydrosalpinx of any size with significant vaginal discharge;
• • 8. Patients with ovarian endometriotic cysts (chocolate cysts) ≥4 cm;
• • 9. Patients who participated in other clinical trials within 3 months before surgery or during the study period;
• • 10. Patients unable to tolerate anesthesia;
• • 11. Patients with genetic abnormalities;
• • 12. Other patients deemed unsuitable for participation in this study by the investigator.