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A clinical study to evaluate the safety and efficacy of 3D exosomes combined with sodium hyaluronate gel perfusion therapy in repairing the endometrium

A clinical study to evaluate the safety and efficacy of 3D exosomes combined with sodium hyaluronate gel perfusion therapy in repairing the endometrium

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600116514
Enrollment
Unknown
Registered
2026-01-12
Start date
2026-01-15
Completion date
Unknown
Last updated
2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometrial injury

Interventions

Experimental Group:Receive 0.5ml of 3D exosomes combined with 0.5ml of sodium hyaluronate once a week for a total of three treatments
Control group:Receive 0.5ml of normal saline (0.9% sodium chloride solution) combined with 0.5ml of sodium hyaluronate once a week for a total of three treatments

Sponsors

The First Affiliated Hospital of Guangxi Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1.Age: 20 to 45 years old, female, body mass index 1.1ng/ml; 6.The TCT test results are normal within one year or both TCT and HPV test results are normal within three years; 7.With full informed consent, voluntarily participate in this study and be able to complete the follow-up on schedule.

Exclusion criteria

Exclusion criteria: 1. Anyone suffering from serious cardiovascular, lung, liver and kidney diseases; Suffering from chronic diseases: diabetes, hypertension, blood disorders, embolic diseases, autoimmune diseases, etc. There are concurrent diseases that seriously endanger patient safety or affect the patient's completion of this study; 2. Those who have not been cured of STI such as AIDS, syphilis, Neisseria gonorrhoeae or chlamydia, as well as those who have not been cured of vaginitis, pelvic inflammatory disease or reproductive tract infectious diseases; Those who have not been cured of alcoholism, drug abuse or drug addiction; 3. Presence of malignant tumors or suspected malignant tumors; 4. There are organic uterine lesions such as uterine malformations, adenomyosis, uterine fibroids, and endometrial hyperplasia, as well as reproductive organ lesions such as hydrosalpinx or ovarian cysts; 5. Those who were pregnant before inclusion or had sexual activity after the onset of menstruation; 6. Suffering from mental illness, including severe hysteria, and lacking autonomy; 7. History of severe allergies or severe immune deficiency; 8. Poor compliance; 9. Participated in other experimental studies in the past three months; 10. Unable to understand the researcher's introduction or explanation of this study; 11. Other circumstances where the researcher deems it unsuitable to participate in the study.

Design outcomes

Primary

MeasureTime frame
The effective rate of improvement in endometrial thickness during the luteal phase;

Secondary

MeasureTime frame
Effective rate of improvement in endometrial thickness during the luteal phase (process);Menstrual blood volume;Endometrial morphology;Self-satisfaction evaluation of the treatment effect by the subjects;

Countries

China

Contacts

Public ContactMo Xiaoliang

The First Affiliated Hospital of Guangxi Medical University

moxiaoliang122@163.com+86 139 7713 8406

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026