The Efficacy of A New Crosslinked Hyaluronan Gel in Prevention of Intrauterine Adhesion

BioRegen

Status: Completed

Conditions: Intrauterine Adhesion

Treatments: Device: new crosslinked hyaluronan gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT03353909

FNL-2016-03

Details and patient eligibility

About

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 for delayed miscarriage in women without previous dilatation and curettage was examined.

Full 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. Settings: Six hospitals for maternal and child health care in China. Patients: Three hundred women undergoing dilatation and curettage for delayed miscarriage without previous dilatation and curettage.

Interventions: Women were randomly assigned into either dilatation and curettage alone group or dilatation and curettage plus new crosslinked hyaluronan gel application group with 1:1 allocation.

Measurements and Outcomes: All patients were evaluated using American Fertility Society classification of IUAs during the follow-up diagnostic hysteroscopy, scheduled 3 months after dilatation and curettage procedure. The primary outcome was the number of women with IUAs, and the secondary outcome was the adhesion scores and the severity of IUAs.

Enrollment: 300 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 2 patient groups

Treatment

Experimental group

Description:

At the end of the dilatation and curettage, new crosslinked hyaluronan gel (3ml) was applied to the uterine cavity in women assigned to the treatment group through a 15-cm sterile cannula.

Treatment:

Device: new crosslinked hyaluronan gel

Control

No Intervention group

Description:

At the end of the dilatation and curettage, nothing was applied to the uterine cavity in women assigned to the control group.