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Comparing the Efficacy of Two Methods for the Therapy of Uterine Adhesion

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ClinicalTrials.gov Identifier: NCT03329898
Recruitment Status : Unknown
Verified November 2017 by Beijing Obstetrics and Gynecology Hospital.
Recruitment status was:  Recruiting
First Posted : November 6, 2017
Last Update Posted : November 17, 2017
Sponsor:
Information provided by (Responsible Party):
Beijing Obstetrics and Gynecology Hospital

Tracking Information
First Submitted Date  ICMJE October 20, 2017
First Posted Date  ICMJE November 6, 2017
Last Update Posted Date November 17, 2017
Actual Study Start Date  ICMJE October 31, 2017
Estimated Primary Completion Date October 25, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 1, 2017)
second diagnostic hysteroscopy [ Time Frame: postoperation three months ]
American fertility society score ,Scores of 1-4, 5-8, and 9-12 were considered to represent mild, moderate, and severe adhesions, respectively
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 1, 2017)
  • pregnancy [ Time Frame: postoperation one year ]
    the number of biochemical pregnancy or clinical pregnancy
  • Menstruation Pattern [ Time Frame: postoperation three months ]
    Amenorrhoea, hypomenorrhea, normal menstrual volume
  • adhesion reformation [ Time Frame: postoperation three months ]
    Adhesion is seen under direct vision by hysteroscopy
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparing the Efficacy of Two Methods for the Therapy of Uterine Adhesion
Official Title  ICMJE 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
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

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Intrauterine Adhesion
Intervention  ICMJE
  • Procedure: dried biological amnion graft
    dried biological amnion graft. The amnion grafts were spread on the balloon end of disposable balloon uterine stent .
    Other Name: uterine application of amnion membrance
  • Device: 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.
  • Drug: estradiol valerate tablets
    oral estradiol valerate tablets, which can promote endometrial growth after operation.
    Other Name: Progynova
  • Drug: dydrogesterone Tablets
    oral dydrogesterone Tablets
    Other Name: Duphaston
Study Arms  ICMJE
  • Experimental: dried biological amnion graft
    dried biological amnion graft patients, who are with IUA, treated by uterine application of dried biological amnion graft + disposable balloon uterine stent + hormones (estradiol valerate tablets+dydrogesterone Tablets) following hysteroscopic adhesiolysis.
    Interventions:
    • Procedure: dried biological amnion graft
    • Device: disposable balloon uterine stent
    • Drug: estradiol valerate tablets
    • Drug: dydrogesterone Tablets
  • Sham Comparator: disposable balloon uterine stent only
    disposable balloon uterine stent patients, who are with IUA, treated by uterine application of disposable balloon uterine stent only + hormones (estradiol valerate tablets+dydrogesterone Tablets) following hysteroscopic adhesiolysis.
    Interventions:
    • Device: disposable balloon uterine stent
    • Drug: estradiol valerate tablets
    • Drug: dydrogesterone Tablets
Publications * Not Provided

*   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: November 1, 2017)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 25, 2018
Estimated Primary Completion Date October 25, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
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 NCT03329898
Other Study ID Numbers  ICMJE No.4-20171020
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
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, PhD Beijing Obstetrics and Gynecology Hospital
PRS Account Beijing Obstetrics and Gynecology Hospital
Verification Date November 2017

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