The Efficacy of Estrogen Therapy Against Adhesion Reformation After Hysteroscopic Adhesiolysis
NCT ID: NCT03351205
Last Updated: 2017-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2017-11-21
2018-11-22
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Uterine cavity barrier only
patients, who are with IUA, treated by uterine application of disposable balloon uterine stent + amnion membrane following hysteroscopic adhesiolysis.
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 compare to Foley catheter.
dried biological amnion graft
Uterine application of dried biological amnion graft following hysteroscopic adhesiolysis.
Other Name: Human amnion membrane
hormone
patients, who are with IUA, treated by uterine application of disposable balloon uterine stent+ amnion membrane+hormones (estradiol valerate tablets+dydrogesterone Tablets) following hysteroscopic adhesiolysis.
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 compare to Foley catheter.
dried biological amnion graft
Uterine application of dried biological amnion graft following hysteroscopic adhesiolysis.
Other Name: Human amnion membrane
estradiol valerate tablets+dydrogesterone tablets
oral estradiol valerate tablets+dydrogesterone tablets
Interventions
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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 compare to Foley catheter.
dried biological amnion graft
Uterine application of dried biological amnion graft following hysteroscopic adhesiolysis.
Other Name: Human amnion membrane
estradiol valerate tablets+dydrogesterone tablets
oral estradiol valerate tablets+dydrogesterone tablets
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
20 Years
40 Years
FEMALE
No
Sponsors
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Beijing Obstetrics and Gynecology Hospital
OTHER
Responsible Party
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Principal Investigators
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Duan Hua, MD
Role: STUDY_CHAIR
Beijing Obstetrics and Gynecology Hospital
Locations
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Beijing Obstetrics and Gynecology Hospital，Capital Medical University
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Liu Zhen
Role: primary
Other Identifiers
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No.6-20171120
Identifier Type: -
Identifier Source: org_study_id