Clinical trial NCT03329898: Comparing the Efficacy of Two Methods for the Therapy of Uterine Adhesion
Official title: Randomized, Controlled Trial to Assess the Efficacy of Disposable Balloon Uterine Stent Combined With Estrogen or Dried Biological Amnion Graft in the Prevention of Adhesion Reformation After Hysteroscopic Adhesiolysis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intrauterine Adhesion
Keywords: Asherman syndrome
uterine stent
hysteroscopy
Lead sponsor: Beijing Obstetrics and Gynecology Hospital
Sponsor class: OTHER
First posted: 2017-11-06
Enrollment: 200
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Eligibility criteria: 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.

Primary outcomes:
measure: second diagnostic hysteroscopy
timeFrame: postoperation three months
Secondary outcomes:
measure: pregnancy
timeFrame: postoperation one year
measure: Menstruation Pattern
timeFrame: postoperation three months
measure: adhesion reformation
timeFrame: postoperation three months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Obstetrics and Gynecology Hospital, Capital Medical University
Study officials:
affiliation: Beijing Obstetrics and Gynecology Hospital
name: Duan Hua, PhD
role: STUDY_CHAIR
References: