Intrauterine Adhesions Clinical Trial
Official title:
The Efficacy and Safety of the Dried Biological Amnion Graft Following Hysteroscopic Lysis for the Prevention of Postoperative Adhesions in Patients With Intrauterine Adhesions
To estimate the efficacy and safety of dried biological amnion graft after hysteroscopic lysis of intrauterine adhesions.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | June 2017 |
Est. primary completion date | January 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 20 Years to 40 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
China | Beijing Obstetrics and Gynecology Hospital,Capital Medical University | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Beijing Obstetrics and Gynecology Hospital |
China,
Amer MI, Abd-El-Maeboud KH. Amnion graft following hysteroscopic lysis of intrauterine adhesions. J Obstet Gynaecol Res. 2006 Dec;32(6):559-66. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | second diagnostic hysteroscopy | postoperation three to four months | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02313415 -
Treatment of Infertility by Collagen Scaffold Loaded With Umbilical Cord Derived Mesenchyma Stem Cells
|
N/A | |
Not yet recruiting |
NCT02132104 -
Efficiency of Amnion Graft to Prevent Intrauterine Adhesions After Hysteroscopic Surgery
|
N/A | |
Completed |
NCT02744807 -
Role of Chronic Endometritis in Postoperative Recurrence of Severe Intrauterine Adhesions
|
N/A | |
Terminated |
NCT01632202 -
Seprafilm Slurry in the Prevention of Uterine Scarring in Patients Undergoing Hysteroscopic Myomectomy
|
Phase 4 | |
Recruiting |
NCT03731689 -
Treatment of Intrauterine Adhesions and Its Distribution of Genital Tract Flora
|
N/A | |
Not yet recruiting |
NCT02404454 -
Prevention of Intrauterine Adhesions After Hysteroscopic Metroplasty With Autocross-linked Hyaluronic Acid Gel
|
N/A | |
Recruiting |
NCT02204358 -
Treatment of Infertility by Collagen Scaffold Loaded With Autologous Bone Marrow Stem Cells
|
Phase 4 |