About this trial
The aim of this study is to compare the efficacy of intrauterine application of heparin solution to the use of hyaluronic acid barrier gel for the prevention of intrauterine adhesion formation after operative hysteroscopy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
female sex
infertility,
irregular bleeding,
oligo-/amenorrhea,
Disqualifiers
ongoing pregnancy,
genital cancer,
pelvic inflammatory disease,
excessive uterine bleeding.
Trial design
Parallel
Treatments tested in this trial
Heparin solution
Drug3 ml saline solution containing 5000 IU heparin.
Anti-adhesion barrier gel
Drug2 ml biodegradable barrier gel containing sodium hyaluronate (10 mg/ml), sodium chloride (8.5 mg/ml), disodium hydrogen phosphate (0.34mg/ml), sodium dihydrogen phosphate (0.14 mg/ml) and water for injection (QS to weight).
Treatment groups
Trial outcomes
Primary outcomes
Number of patients with post-operative intrauterine adhesion formation
Incidence and severity of intrauterine adhesions identified at follow-up diagnostic hysteroscopy as assessed according to Valle and Sciarra's classification of intrauterine synaechia
Number of patients with need for subsequent operative hysterectomy
Pathological findings at second-look hysteroscopy taken as indication for successive uterine surgery
Number of patients with persistent irregular menstrual bleeding
Recurring abnormal menstrual cycle patterns identified post initial surgery
Secondary outcomes
Number of patients with fertility improvement
Successful pregnancy post surgical procedure
Sponsors and contacts
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