The Efficacy and Safety of the Dried Biological Amnion Graft in Patients With Intrauterine Adhesions
NCT ID: NCT02496052
Last Updated: 2015-07-17
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
300 participants
INTERVENTIONAL
2013-01-31
2017-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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dried biological amnion graft
patients, who are with IUA, treated by uterine application of amnion membrane + Foley balloon+ hormones (estradiol valerate tablets+dydrogesterone Tablets) following hysteroscopic adhesiolysis.
dried biological amnion graft
Uterine application of amnion membrane following hysteroscopic adhesiolysis. Other Name: Human amnion membrane
Foley balloon
Device: Foley balloon Uterine application of Foley balloon
estradiol valerate tablets+dydrogesterone Tablets
oral estradiol valerate tablets+dydrogesterone Tablets
Foley catheter balloon only
patients, who are with IUA, treated by uterine application of Foley balloon only+ hormones (estradiol valerate tablets+dydrogesterone Tablets) following hysteroscopic adhesiolysis.
Foley balloon
Device: Foley balloon Uterine application of Foley balloon
estradiol valerate tablets+dydrogesterone Tablets
oral estradiol valerate tablets+dydrogesterone Tablets
Interventions
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dried biological amnion graft
Uterine application of amnion membrane following hysteroscopic adhesiolysis. Other Name: Human amnion membrane
Foley balloon
Device: Foley balloon Uterine application of Foley balloon
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
Yes
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, Ph.D
Role: STUDY_CHAIR
Beijing Obstetrics and Gynecology Hospital
Locations
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Beijing Obstetrics and Gynecology Hospital，Capital Medical University
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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Amer MI, Abd-El-Maeboud KH. Amnion graft following hysteroscopic lysis of intrauterine adhesions. J Obstet Gynaecol Res. 2006 Dec;32(6):559-66. doi: 10.1111/j.1447-0756.2006.00454.x.
Gan L, Duan H, Sun FQ, Xu Q, Tang YQ, Wang S. Efficacy of freeze-dried amnion graft following hysteroscopic adhesiolysis of severe intrauterine adhesions. Int J Gynaecol Obstet. 2017 May;137(2):116-122. doi: 10.1002/ijgo.12112. Epub 2017 Mar 1.
Other Identifiers
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2014-1-2112
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
zylx201406
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
NO.1-20140601
Identifier Type: -
Identifier Source: org_study_id
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