No. 26, Second Horizontal Road, Yan Village, Tianhe District
Guangzhou, Guangdong, 510600, China
NCT Number: NCT07416578
Intrauterine adhesions (IUA) is a group of diseases caused by endometrial injury leading to occlusion of the uterine cavity and serious abnormality of the uterine cavity morphology, which causes primary or secondary infertility by affecting embryo implantation. At present, the poor effectiveness of clinical treatment methods has made the thin endometrium after intrauterine adhesions an urgent problem to be solved in the clinical field of assisted reproduction.
Stem cells with multi-directional differentiation potential provide a new idea for the treatment of cervical adhesions. However, due to limitations such as stem cell extraction, technical conditions, and ethical issues, clinical application cannot be widely carried out. Exosomes are vesicle structures produced by paracrine secretion of cells, containing abundant proteins, RNA, etc., and mediating information exchange between cells. Recent studies have found that stem cells play a role in tissue repair mainly through paracrine, and stem cell-derived exosomes have similar functions to stem cells. Human cord mesenchymal stem cells were selected as an intervention for this clinical study because of their wide source, easy access, and low immunogenicity.
Therefore, in this clinical study, the investigator will evaluate the clinical safety and efficacy of infusing human umbilical cord mesenchymal stem cell exosomes into the uterine cavity for the treatment of thin endometrium after intrauterine adhesions.
This study is active but is not currently recruiting participants.
Notify Me20 year–38 year
Female
Interventional
Not applicable
Guangzhou, Guangdong, 510600, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
After hysteroscopy, immediate intracavitary perfusion therapy with exosomes was administered.
After hysteroscopy, traditional hormone replacement therapy (HRT) cycle drug treatment was performed (from the day of the surgery to the 25th day of the menstrual cycle, 3 mg of estradiol valerate (Climen) was taken twice a day, and on the 16th day of the menstrual cycle, 10 mg of dydrogesterone (Duphaston) was added twice a day for 10 days).
Time frame: One month after hysteroscopy surgery
The thickness of the endometrium was measured through three-dimensional color ultrasound examination of the uterus. The thickness (in millimeters) of the endometrium before and after the hysteroscopy procedure was recorded.
Time frame: 1-1.5year
By conducting regular postoperative follow-ups on the participants, the investigator can observe their pregnancy outcomes and record whether they have successfully achieved clinical pregnancy.
Time frame: 1-1.5year
By conducting regular postoperative follow-ups on the participates, the investigator can observe their pregnancy outcomes and record whether they have successfully achieved clinical pregnancy.
Sixth Affiliated Hospital, Sun Yat-sen University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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