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The Efficacy and Safety of the Dried Biological Amnion Graft in Patients With Intrauterine Adhesions

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ClinicalTrials.gov Identifier: NCT02496052
Recruitment Status : Unknown
Verified July 2015 by Beijing Obstetrics and Gynecology Hospital.
Recruitment status was:  Recruiting
First Posted : July 14, 2015
Last Update Posted : July 17, 2015
Sponsor:
Information provided by (Responsible Party):
Beijing Obstetrics and Gynecology Hospital

Tracking Information
First Submitted Date  ICMJE July 6, 2015
First Posted Date  ICMJE July 14, 2015
Last Update Posted Date July 17, 2015
Study Start Date  ICMJE January 2013
Estimated Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 13, 2015)
second diagnostic hysteroscopy [ Time Frame: postoperation three to four months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Efficacy and Safety of the Dried Biological Amnion Graft in Patients With Intrauterine Adhesions
Official Title  ICMJE The Efficacy and Safety of the Dried Biological Amnion Graft Following Hysteroscopic Lysis for the Prevention of Postoperative Adhesions in Patients With Intrauterine Adhesions
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE Intrauterine Adhesions
Intervention  ICMJE
  • Procedure: dried biological amnion graft
    Uterine application of amnion membrane following hysteroscopic adhesiolysis. Other Name: Human amnion membrane
    Other Name: Uterine application of amnion membrane
  • Device: Foley balloon
    Device: Foley balloon Uterine application of Foley balloon
    Other Name: Device: Foley balloon Uterine application of Foley balloon
  • Drug: estradiol valerate tablets+dydrogesterone Tablets
    oral estradiol valerate tablets+dydrogesterone Tablets
    Other Name: Progynova+dydrogesterone
Study Arms  ICMJE
  • Experimental: 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.
    Interventions:
    • Procedure: dried biological amnion graft
    • Device: Foley balloon
    • Drug: estradiol valerate tablets+dydrogesterone Tablets
  • Sham Comparator: 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.
    Interventions:
    • Device: Foley balloon
    • Drug: estradiol valerate tablets+dydrogesterone Tablets
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 13, 2015)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2017
Estimated Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02496052
Other Study ID Numbers  ICMJE NO.1-20140601
2014-1-2112 ( Other Grant/Funding Number: The capital health research and development of special )
zylx201406 ( Other Grant/Funding Number: Beijing Municipal Administration of Hospitals Clinical Medicine Development of Special Funding Support )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Beijing Obstetrics and Gynecology Hospital
Study Sponsor  ICMJE Beijing Obstetrics and Gynecology Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Duan Hua, Ph.D Beijing Obstetrics and Gynecology Hospital
PRS Account Beijing Obstetrics and Gynecology Hospital
Verification Date July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP