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Application of extracellular matrix combined with uterine balloon in promoting endometrial repair: a prospective randomized controlled clinical study

Application of extracellular matrix combined with uterine balloon in promoting endometrial repair: a prospective randomized controlled clinical study

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100052027
Enrollment
Unknown
Registered
2021-10-14
Start date
2021-10-01
Completion date
Unknown
Last updated
2022-06-27

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

Conditions

Intrauterine adhesions

Interventions

Experimental group:BM(basement membrane) and intrauterine balloon implantation for 5 days
Control group:Intrauterine balloon implantation for 5 days

Sponsors

Shanghai Changzheng Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
No minimum to 40 Years

Inclusion criteria

Inclusion criteria: 1. Aged <= 40 years; 2. BMI 18-27.9kg/m2; 3. Who infertility diagnosis; 4. IVF / ICSI assisted pregnancy with at least 2 high-quality embryos; 5. Female patients with clinically diagnosed moderate to severe intrauterine adhesions (in line with AFS 1988 classification standard); 6. Patients who agreed to hysteroscopy and postoperative review; 7. Patients who can understand and cooperate with the clinical research process, and can comply with the requirements of the research protocol until the completion of the research; 8. Patients who agree to enter the clinical research and voluntarily sign the written informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with unexplained irregular vaginal bleeding; 2. Patients with ovarian, pituitary or hypothalamic amenorrhea; 3. Patients with uterine malformation; 4. Patients with hysteromyoma > 2 cm, adenomyosis and severe pelvic endometriosis; 5. Patients with a history of malignant or borderline tumors; 6. Patients with breast hyperplasia and other related diseases; 7. Patients with history of pelvic tuberculosis and acute infection of genitourinary system; 8. Patients with serious cardiovascular and cerebrovascular diseases, respiratory and digestive diseases; 9. Patients with severe history of thrombotic disease and family history; 10. Patients with severe liver and kidney dysfunction and immune system disorder; 11. Mental illness or serious mental illness; 12. Other diseases that do not meet the requirements of human assisted reproductive technology for pregnancy; 13. Those who have a history of allergy to pig derived products; 14. Those who cannot accept pig derived materials due to religious belief, nationality and other problems; 15. The researchers believe that other patients are not suitable for inclusion.

Design outcomes

Primary

MeasureTime frame
The effective rate of repairing intrauterine adhesions;

Secondary

MeasureTime frame
Endometrial thickness;Menstrual volume;Clinical pregnancy rate;

Countries

China

Contacts

Public ContactLi Wen

Shanghai Changzheng Hospital

liwenlyy@sina.com+86 18017310170

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 17, 2026