Evaluating Mechanically Engineered Stem Cell Exosomes for Treating Endometrial Injury: A Clinical… (NCT06896747) | Clinical Trial Compass
RecruitingPhase 1/2
Evaluating Mechanically Engineered Stem Cell Exosomes for Treating Endometrial Injury: A Clinical Study
China90 participantsStarted 2025-02-21
Plain-language summary
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.
Who can participate
Age range
20 Years – 40 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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;