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Clinical Study on the Safety and Efficacy of Human-Derived Engineered Extracellular Matrix Combined with Sodium Hyaluronate Gel Perfusion in Endometrial Repair

Clinical Study on the Safety and Efficacy of Human-Derived Engineered Extracellular Matrix Combined with Sodium Hyaluronate Gel Perfusion in Endometrial Repair

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500113586
Enrollment
Unknown
Registered
2025-12-01
Start date
2025-12-01
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Decreased menstrual flow

Interventions

Experimental Group:Human-Derived Engineered Extracellular Matrix Lyophilized Powder Combined with Sodium Hyaluronate for Treatment
Control Group:Treatment with Lyophilized Powder (Without Human-Derived Engineered Extracellular Matrix) Combined with Sodium Hyaluronate

Sponsors

The Seventh Affiliated Hospital Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. Age: 20-45 years old, Female, Body Mass Index (BMI) 1.1 ng/ml; 6. The TCT test result is normal within one year, or both the TCT and HPV test results are normal within three years; 7. After providing full informed consent, the participant voluntarily participates in this study and is able to complete the follow-up as scheduled;

Exclusion criteria

Exclusion criteria: 1. Any individual with severe cardiovascular, pulmonary, hepatic, or renal diseases; those with chronic diseases such as diabetes mellitus, hypertension, hematological diseases, thromboembolic diseases, autoimmune diseases, etc.; or those with comorbid diseases that seriously endanger the participant's safety or affect their ability to complete this study; 2. Those with untreated sexually transmitted infections (STIs) such as AIDS, syphilis, gonorrhea, or chlamydia; those with unresolved vaginitis, pelvic inflammatory disease, or other genital tract infectious diseases; and those with untreated alcoholism, drug use, or drug addiction. 3. There is a malignant tumor or a suspected malignant tumor; 4. There are uterine organic lesions such as uterine malformation, adenomyosis, uterine fibroids, and endometrial hyperplasia, as well as reproductive organ lesions such as hydrosalpinx or ovarian cysts; 5. Those who have been pregnant before enrollment, or have had sexual intercourse after the onset of menstruation; 6. Those with mental illnesses, including severe hysteria, who lack the capacity for autonomy; 7. History of severe allergies, history of severe immunodeficiency; 8. People with poor adherence; 9. Have participated in other experimental studies in the recent 3 months; 10. Unable to understand the researcher's introduction or explanation of this study; 11. Other circumstances deemed unsuitable for participation in the study by the researcher.

Design outcomes

Primary

MeasureTime frame
Effective rate of endometrial thickness improvement during the periovulatory period;

Secondary

MeasureTime frame
Uterine Cavity Morphology;Menstrual blood volume;Subjects' Self-Assessment of Treatment Effect Satisfaction;Effective rate of endometrial thickness improvement during the periovulatory period (process);

Countries

China

Contacts

Public ContactLi Tian

The Seventh Affiliated Hospital Sun Yat-sen University

litian@sysush.com+86 7551234567

Outcome results

None listed

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