New Cross-linked Hyaluronan Gel to Prevent Adhesion After USG-MVA: RCT
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorChinese University of Hong Kong
About this trial
The objective of this prospective, randomized controlled study was to evaluate the effectiveness of this NCH gel in the prevention of IUA development as assessed by hysteroscopy after USG-MVA, in the treatment for first-trimester miscarriage.
* To study the severity and extent of the IUA as assessed by the AFS and ESGE adhesion score in both groups of patients. * To examine the rate of complications or side effects with the NCH gel. * To assess the subsequent menstrual history and reproductive outcome in both groups of patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Women 18 years old or above
No previous history of IUA/ Asherman's syndrome
No previous surgical history of EVA or dilatation or curettage or surgical termination of pregnancy or caesarean section
No previous history of therapeutic hysteroscopic surgeries
Disqualifiers
previous therapeutic hysteroscopic procedures (e.g. endometrial ablation, removal of fibroids or polyps, surgical correction of congenital uterine anomalies or adhesiolysis)
suspicion of molar pregnancy
genital tract malformation
suspicion of active infection or genital tract malignancy or genital tuberculosis
Trial design
Design model
Parallel
Treatments tested in this trial
MateRegen® gel (BioRegen)
DeviceModification of Hyaluronic acid structure to 3-dimensional self-cross-linked network structure enables all-dimensional coverage of tissue surface to enhance better healing process. Self-cross-linked HA hydrogels can maintain the biocompatibility and biodegradability that characterize the unmodified material. Moreover, high dynamic viscosity enables continuous indwelling in the uterine cavity. The gel could provide precise regulation, and degradation and absorption time prolonged to 7-14 days post operatively, which completely cover key postoperative healing period (5-7 days), at the highest time of intrauterine adhesion formation.
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: Intervention group (Group A): NCH gel after USG-MVAExperimental treatment 1 intervention
Group B: Controlled group (Group B): No NCH gel after USG-MVANo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Incidence of IUA
To determine the incidence of IUA or after USG-MVA for the treatment of first-trimester miscarriage in both intervention and control groups.
Time frame
8-12 weeks after MVASecondary outcomes
1
Severity and extent of the intrauterine adhesions as assessed by the AFS adhesion score
To study the severity and extent of the intrauterine adhesions as assessed by the AFS adhesion score in both groups of patients. The American Fertility Society's (AFS) classification of intrauterine adhesions: Stage I (mild) with score 1-4, Stage II (moderate) with score 5-8, Stage III (severe) with score 9-12
Time frame
8-12 weeks after MVA2
Severity and extent of the intrauterine adhesions as assessed by the ESGE adhesion score
To study the severity and extent of the intrauterine adhesions as assessed by the European Society of Gynaecological Endoscopy (ESGE) adhesion score in both groups of patients. It includes grades I and II as mild adhesion, grade III as moderate adhesion, grades IV and V as severe adhesion
Time frame
8-12 weeks after MVA3
Complications or side effects with the NCH gel.
To examine the rate of complications or side effects with the NCH gel.
Time frame
8-12 weeks after MVA4
Subsequent menstrual frequency
To assess the subsequent menstrual frequency in both groups of patients. Frequency - average 28 days \<24 days Frequent, \>38 days Infrequent Frequency - average 28 days \<24 days Frequent, \>38 days Infrequent
Time frame
8-12 weeks after MVASponsors and contacts
Click on the lead sponsor to view all of their trials.
Chinese University of Hong Kong
Lead sponsor
Health and Medical Research Fund
Collaborator
Source ClinicalTrials.gov