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A multicenter randomized controlled trial of crosslinked sodium hyaluronate gel for the prevention of re-adhsion after hysteroscopic adhesiolysis with cold scissors for moderate/severe intrauterine adhesion

A multicenter randomized controlled trial of crosslinked sodium hyaluronate gel for the prevention of re-adhsion after hysteroscopic adhesiolysis with cold scissors for moderate/severe intrauterine adhesion

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200062384
Enrollment
Unknown
Registered
2022-08-03
Start date
2022-08-01
Completion date
Unknown
Last updated
2023-04-12

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

Conditions

Intrauterine adhesion

Interventions

hyaluronate gel:hyaluronate gel
balloon:Balloon
hyaluronate gel+Balloon:hyaluronate gel+Balloon

Sponsors

West China Second Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1) Patients with moderate to severe intrauterine adhesions confirmed by hysteroscopy in the outpatient department (Chinese scoring standard for the diagnosis of intrauterine adhesions or AFS scoring standard for intrauterine adhesions); Or those who are suspected of intrauterine adhesions by clinical or color Doppler ultrasound, and have a pre score of >= 6 points (endometrial thickness in the late proliferative period + menstrual status + previous pregnancy history + previous curettage History) in accordance with the grading criteria for the diagnosis of intrauterine adhesions in China. 2) Age 18-40 years old; 3) Obtain informed consent to participate in the study and agree to take contraceptive measures within 3 months after operation; 4) Good compliance, willing and able to carry out follow-up observation as required after operation, and can go to our hospital for hysteroscopy within 1-2 months after operation; 5) The clinical and laboratory examinations showed that the liver and kidney functions were normal without serious systemic diseases.

Exclusion criteria

Exclusion criteria: 1) Age >45 years old, weight >100 kg, BMI > 28 kg/m2.; 2) Mild intrauterine adhesion; 3) Pregnant women and postmenopausal women (FSH > 40 miu/ml, estradiol <20 pg/ml);, 4) Pelvic inflammation, malignant tumor of reproductive tract and other systemic diseases causing abnormal uterine bleeding; 5) No intrauterine adhesion found during hysteroscopy; 6) Perforation in hysteroscopic surgery; 7) Breast birads4 or other contraindications to estrogen and progesterone.

Design outcomes

Primary

MeasureTime frame
Adhesion score;

Secondary

MeasureTime frame
Menstruation;Pregnancy;

Countries

China

Contacts

Public ContactXin Tan
tan8336@icloud.com+86 13568808828

Outcome results

None listed

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