Using engineered stem cell exosomes to treat thin endometrial lining in women

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of mechanically engineered umbilical cord-derived stem cell exosomes compared to conventional exosomes and platelet-rich plasma (PRP) in improving endometrial thickness in women with thin endometrium due to intrauterine adhesions. Participants will receive one of the three treatments via subendometrial injection and will be monitored for changes in endometrial parameters and clinical pregnancy rates. The study aims to determine if the engineered exosomes provide superior therapeutic effects over the other treatments.

Why it matters

Who can join: the full rules

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.

Where it's running

• Tang-Du Hospital
  Xi'an, Shaanxi, China Recruiting
• Tang-Du Hospital
  Xi'an, Shaanxi, China Recruiting

Study contacts

• Principal investigator: The Fourth Military Medical University — Air Force Military Medical University, China
• Study coordinator: Wanlin Zhang, PhD
• Email: 1843678023@qq.com
• Phone: +86 18149363396

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.