Status:
COMPLETED
The Efficacy of A New Crosslinked Hyaluronan Gel in Prevention of Intrauterine Adhesion
Lead Sponsor:
BioRegen Biomedical (CHangzhou) Co., Ltd
Conditions:
Intrauterine Adhesion
Eligibility:
FEMALE
18-45 years
Phase:
NA
Brief Summary
Using American Fertility Society classification of intrauterine adhesions, the efficacy of a new crosslinked hyaluronan gel in reducing intrauterine adhesion formation after dilatation and curettage f...
Detailed Description
Study Objectives: To evaluate the efficacy of a new crosslinked hyaluronan gel in reducing intrauterine adhesions formation after dilatation and curettage. Design: Randomized controlled trial. Settin...
Eligibility Criteria
Inclusion
- The inclusion criteria:
- Patients to be female, aged 18-45 years
- Without previous dilatation and curettage
- Undergoing dilatation and curettage for the current delayed miscarriage
- All participants should be with normal liver/rental function and without systemic disease
- Agree to use adequate forms of contraception throughout the study
- Be in good compliance with the follow-up examination according to the study protocol.
- The exclusion criteria:
- Known/suspected intolerance or hypersensitivity to hyaluronan or its derivatives
- Genital tract malformation
- Inflammation of genital tract or pelvic cavity, clinical evidence of cancer in genital tract
- Suspected genital tuberculosis
- Abnormal blood coagulation
- Medical histories of peripheral vascular disease, alcohol/drug abuse, and mental illness
- Acute or severe infection
- Autoimmune diseases.
Exclusion
Key Trial Info
Start Date :
July 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 15 2017
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT03353909
Start Date
July 1 2016
End Date
February 15 2017
Last Update
November 27 2017
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