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
Qualifiers
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
Treatments tested in this trial
- MateRegen® gel (BioRegen)
Treatment groups
150 Participants
are divided into 2 treatment groupsSponsors and collaborators
Chinese University of Hong Kong
Lead sponsor
Health and Medical Research Fund
Collaborator
Source ClinicalTrials.gov