Comparing the Efficacy of Two Methods in the Prevention of Adhesion Reformation After Hysteroscopic Adhesiolysis
- Conditions
- Intrauterine Adhesion
- Interventions
- Device: disposable balloon uterine stentProcedure: dried biological amnion graft
- Registration Number
- NCT03346317
- Lead Sponsor
- Beijing Obstetrics and Gynecology Hospital
- Brief Summary
Asherman's syndrome is characterized by the presence of intrauterine adhesions (IUA) as well as symptoms such as amenorrhea, hypomenorrhea, pelvic pain, and infertility. The gold standard for the treatment of intrauterine adhesions is hysteroscopic intrauterine adhesions. The recurrence of intrauterine adhesions is a major challenge in clinical practice. It has been reported that dried biological aminion graft was used to prevent adhesion after the operation of intrauterine adhesions. Estrogen is also used for postoperative prevention of intrauterine adhesions. Intrauterine balloon can reduce the recurrence of adhesions after operation. Does the combination of balloon with amniotic products or estrogen can improve clinical outcomes? Therefore, this study was conducted.
- Detailed Description
Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double (participant and outcomes Assessor) Primary Purpose: Prevention
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 100
- age 20-40 years；
- previously diagnostic hysteroscopy confirmed adhesion score >5， according to the American Fertility Society （AFS）classification of IUA；
- complains of menstruation disorder and reproductive dysfunction；
- informed consent.
- premature menopause,
- presence of other intrauterine lesions (e.g. polyps, myoma, septa), and
- presence of severe intercurrent illness (e.g. systemic disease, coagulative disorders, severe kidney and liver diseases),
- adhesions limited to the lower uterine cavity or the cervical canal.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description dried biological amnion graft disposable balloon uterine stent patients, who are with IUA, treated by uterine application of disposable balloon uterine stent + amnion membrane following hysteroscopic adhesiolysis. estrogen estradiol valerate tablets+dydrogesterone tablets patients, who are with IUA, treated by uterine application of disposable balloon uterine stent+ hormones (estradiol valerate tablets+dydrogesterone Tablets) following hysteroscopic adhesiolysis. estrogen disposable balloon uterine stent patients, who are with IUA, treated by uterine application of disposable balloon uterine stent+ hormones (estradiol valerate tablets+dydrogesterone Tablets) following hysteroscopic adhesiolysis. dried biological amnion graft dried biological amnion graft patients, who are with IUA, treated by uterine application of disposable balloon uterine stent + amnion membrane following hysteroscopic adhesiolysis.
- Primary Outcome Measures
Name Time Method Incidence of adhesion information Within the first 3 months after surgery Intrauterine adhesions under hysteroscopy
- Secondary Outcome Measures
Name Time Method Menstruation pattern Within the first 3 months after surgery menstrual volume which was assessed by pictorial blood loss assessment chart
The change of AFS score Within the first 3 months after surgery The American Fertility Society ( AFS ) scoring system (1988 version). Scores of 1-4, 5-8, and 9-12 were mild, moderate, and severe adhesions, respectively.
Trial Locations
- Locations (1)
Beijing Obstetrics and Gynecology Hospital，Capital Medical University
🇨🇳Beijing, Beijing, China