Intrauterine Adhesion
Conditions
Keywords
Asherman syndrome, uterine stent, hysteroscopy
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. Intrauterine balloon can reduce the recurrence of adhesions after operation. Does the combination of balloon and amniotic products can improve clinical outcomes? Therefore, this study was conducted.
Detailed description
The diaposable balloon uterine(a special intrauterine balloon) is usually inserted into the uterine after a hysteroscopic adhesiolysis and removed after on the 7th day after surgery. Another group, the diaposable balloon uterin and dried biological amnion will be inserted into the uterine after a hysteroscopic adhesiolysis and removed after on the 7th day after surgery.Several investigators demonstrated its favorable effect in the recurrence of adhesion after the treatment of intrauterine adhesion. Disposable balloon uterine stent is specially designed to fit into the cavity of the uterus, and usually removed on the 7th day after surgery. Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention
Interventions
PROCEDUREdried biological amnion graft
dried biological amnion graft. The amnion grafts were spread on the balloon end of disposable balloon uterine stent .
the disposable balloon uterine stent is heart-shaped that resembled the shape of the uterine cavity and could fully separate the two sides of the uterine wall and the corners of the uterus.
DRUGestradiol valerate tablets
oral estradiol valerate tablets, which can promote endometrial growth after operation.
oral dydrogesterone Tablets
Sponsors
Beijing Obstetrics and Gynecology Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* age 20-45 years. * previously diagnostic hysteroscopy confirmed adhesion score ≧5， according to the American Fertility Society (AFS). * complains of menstruation disorder and reproductive dysfunction. * informed consent.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| second diagnostic hysteroscopy | postoperation three months | American fertility society score ,Scores of 1-4, 5-8, and 9-12 were considered to represent mild, moderate, and severe adhesions, respectively |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| pregnancy | postoperation one year | the number of biochemical pregnancy or clinical pregnancy |
| Menstruation Pattern | postoperation three months | Amenorrhoea, hypomenorrhea, normal menstrual volume |
| adhesion reformation | postoperation three months | Adhesion is seen under direct vision by hysteroscopy |
Countries
China
Contacts
Primary ContactZhu Ru, MD
Backup ContactWang Sha, PhD
Outcome results
None listed