Intrauterine Adhesions
Conditions
Keywords
amnion graft, New biological barrier system
Brief summary
To estimate the efficacy and safety of dried biological amnion graft after hysteroscopic lysis of intrauterine adhesions.
Detailed description
Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention
Interventions
PROCEDUREdried biological amnion graft
Uterine application of amnion membrane following hysteroscopic adhesiolysis. Other Name: Human amnion membrane
DEVICEFoley balloon
Device: Foley balloon Uterine application of Foley balloon
oral estradiol valerate tablets+dydrogesterone Tablets
Sponsors
Beijing Obstetrics and Gynecology Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
Yes
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 |
|---|---|
| second diagnostic hysteroscopy | postoperation three to four months |
Countries
China
Contacts
Primary ContactWang Xin, MD
Backup ContactGan Lu, MD
Outcome results
None listed