Clinical Study of Umbilical Cord Mesenchymal Stem Cells Combined With Collagen Scaffold in the Tr… (NCT03724617) | Clinical Trial Compass
CompletedNot Applicable
Clinical Study of Umbilical Cord Mesenchymal Stem Cells Combined With Collagen Scaffold in the Treatment of Thin Endometrium
China18 participantsStarted 2018-10-29
Plain-language summary
This is a non-blind self-control trial. We mainly compare the changes of endometrial thickness，changes in menstrual flow, and improvement in pregnancy before and after stem cell treatment in patients with thin endometrium.
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
. According to the GCP regulations, obtain the informed consent of the subject, volunteer for the test, and have signed the informed consent form.
. Women aged 20-40 years with fertility requirements
. Infertility patients who are treated in this hospital
. After more than 2 times of hysteroscopic adhesion separation surgery, the uterine cavity morphology has basically returned to normal. The patient has a normal menstrual cycle or an estrogenic dose of 6 mg per day, and the highest thickness of the endometrium is 5.5 mm in 6 cycles by ultrasound.
. or receive adjuvant reproductive treatment, the endometrial thickness is less than 5.5mm for unknown reasons, the treatment of estrogen, colony stimulating factor, aspirin, sildenafil and other drugs up to 8mg / day is invalid.
. HBVAg negative, HCV negative, HIV negative, syphilis negative
. Normal bone marrow morphology, normal blood routine
. Previously failed to receive relevant stem cell therapy
Exclusion criteria
. Those who cannot accept the treatment observation process required by the test
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.
What they're measuring
1
the change of endometrial thickness
Timeframe: Change from Baseline endometrial thickness at 6 months
. There are contraindications for hysteroscopic surgery;
. congenital uterine malformation; severe adenomyosis; uterine fibroids that may affect embryo implantation; the investigators judged that there are other uterine factors that are not suitable for embryo implantation
. Patients with chromosomal abnormalities
. contraindications to estrogen therapy; systemic diseases such as thrombosis, cardiopulmonary disease, hematopoietic diseases, malignant tumors, etc.