Intrauterine Adhesion
Conditions
Keywords
Asherman syndrome, hysteroscopy, uterine stent, Estrogen, Amnion, Hysteroscopic Adhesiolysis
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. Intrauterine balloon has been used for the prevention of intrauterine adhesions. It has been reported that dried biological amnion 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. Disposable balloon uterine stent，which is an innovative intrauterine balloon，is specially designed to fit into the cavity of the uterus. Does Disposable balloon uterine stent and amniotic products combine estrogen therapy 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
Interventions
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 compare to Foley catheter.
PROCEDUREdried biological amnion graft
Uterine application of dried biological amnion graft following hysteroscopic adhesiolysis. Other Name: Human amnion membrane
oral estradiol valerate tablets+dydrogesterone tablets
Sponsors
Beijing Obstetrics and Gynecology Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* 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.
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 |
|---|---|---|
| Incidence of adhesion information | Within the first 3 months after surgery | Intrauterine adhesions under hysteroscopy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | he American Fertility Society ( AFS ) scoring system (1988 version). Scores of 1-4, 5-8, and 9-12 were mild, moderate, and severe adhesions, respectively. |
Countries
China
Contacts
Primary ContactZhu Ru, MD
Backup ContactWang Sha, MD
Outcome results
None listed