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

Primary Purpose

Intrauterine Adhesion

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

new crosslinked hyaluronan gel

About this trial

This is an interventional prevention trial for Intrauterine Adhesion focused on measuring Intrauterine adhesion, Delayed miscarriage, hyaluronan gel

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Treatment

Control

Arm 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.

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

Outcomes

Primary Outcome Measures

Incidence of intrauterine adhesion

The number of women with intrauterine adhesion

Secondary Outcome Measures

The adhesion scores of extent of uterine cavity involved

Evaluated according to American Fertility Society classification of intrauterine adhesion during the follow-up diagnostic hysteroscopy: 1 point (<1/3 cavity with adhesion), 2 points (1/3-2/3 cavity with adhesion) and 4 points (>2/3 cavity with adhesion), high values represent worse outcome

The adhesion scores of type of adhesion

Evaluated according to American Fertility Society classification of intrauterine adhesion during the follow-up diagnostic hysteroscopy: 1 point (filmy adhesion), 2 points (filmy & dense adhesion) and 4 points (dense adhesion), high values represent worse outcome

The adhesion scores of menstrual pattern

Evaluated according to American Fertility Society classification of intrauterine adhesion during the follow-up diagnostic hysteroscopy: 0 point (normal), 2 points (hypomenorrhea) and 4 points (amenorrhea), high values represent worse outcome

Cumulative adhesion score

The summed score of the adhesion scores of extent of uterine cavity involved, type of adhesion and menstrual pattern; range: 1-12 points, high values represent worse outcome

Severity

Graded according to cumulative adhesion score: Stage I (mild)(1-4 points), Stage II (moderate)(5-8 points) and Stage III (severe)(9-12 points).

Full Information

NCT ID

NCT03353909

First Posted

October 10, 2017

Last Updated

November 23, 2017

Sponsor

BioRegen Biomedical (CHangzhou) Co., Ltd

1. Study Identification

Unique Protocol Identification Number

NCT03353909

Brief Title

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

Official Title

The Efficacy of A New Crosslinked Hyaluronan Gel in the Prevention of Postoperative Intrauterine Adhesion After Dilatation and Curettage in Women With Delayed Miscarriage: A Prospective, Randomized, Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Completed

Study Start Date

July 1, 2016 (Actual)

Primary Completion Date

February 15, 2017 (Actual)

Study Completion Date

February 15, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

BioRegen Biomedical (CHangzhou) Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Intrauterine Adhesion

Keywords

Intrauterine adhesion, Delayed miscarriage, hyaluronan gel

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

300 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment

Arm Type

Experimental

Arm 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.

Arm Title

Control

Arm Type

No Intervention

Arm Description

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

Intervention Type

Device

Intervention Name(s)

new crosslinked hyaluronan gel

Other Intervention Name(s)

MateRegen Gel

Intervention Description

At the end of the dilatation and curettage, new crosslinked hyaluronan gel was applied to the uterine cavity.

Primary Outcome Measure Information:

Title

Incidence of intrauterine adhesion

Description

The number of women with intrauterine adhesion

Time Frame