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

About this trial

Last updated a year ago

Study ID

2024LC2421

Status

Recruiting

Type

Interventional

Phase

Phase 1

Placebo

Accepting

20 to 40 Years

Female

Trial Timing

Started a year ago

What is this trial 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.

What are the participation requirements?

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.