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New treatment option for Thin Endometrial Lining
Official title Evaluating Mechanically Engineered Stem Cell Exosomes for Treating Endometrial Injury: A Clinical Study
ClinicalTrials.gov ID: NCT06896747
What this study is testing
What is Mechanically Engineered Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes?
Mechanically Engineered Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for thin endometrial lining.
Also referred to as ME-UCMSC-Exo, RH-Exo.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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)?
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 to 40, women only
You may be able to join if
- 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...
You likely can't join if
- 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...
See the full eligibility criteria
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Xi'an, Shaanxi, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 20 years to 40 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Xi'an, Shaanxi, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.