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Efficiency of Amnion Graft to Prevent Intrauterine Adhesions After Hysteroscopic Surgery

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ClinicalTrials.gov Identifier: NCT02132104
Recruitment Status : Unknown
Verified October 2014 by XUEBING PENG, Capital Medical University.
Recruitment status was:  Not yet recruiting
First Posted : May 7, 2014
Last Update Posted : October 21, 2014
Sponsor:
Information provided by (Responsible Party):
XUEBING PENG, Capital Medical University

Brief Summary:
The purpose of the study is to evaluate whether human amnion graft reduces the reformation of severe intrauterine adhesions (IUA) following hysteroscopic adhesiolysis.

Condition or disease Intervention/treatment Phase
Intrauterine Adhesions Procedure: Uterine application of amnion membrane Device: Foley balloon Drug: Femoston Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 208 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Amnion Graft for Preventing Intrauterine Adhesions Following Hysteroscopic Surgery
Study Start Date : November 2014
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adhesions Hormones

Arm Intervention/treatment
Experimental: amnion graft in severe IUA
patients, who are with severe IUA, treated by uterine application of amnion membrane + Foley balloon+ hormones (Femoston) following hysteroscopic adhesiolysis.
Procedure: Uterine application of amnion membrane
Uterine application of amnion membrane following hysteroscopic adhesiolysis.
Other Name: Human amnion membrane

Device: Foley balloon
Uterine application of Foley balloon

Drug: Femoston
Hormones treatment after surgery.
Other Name: Hormones

Sham Comparator: non-amnion graft in severe IUA
patients, who are with severe IUA, treated by Foley balloon+ hormones (Femoston) following hysteroscopic adhesiolysis.
Device: Foley balloon
Uterine application of Foley balloon

Drug: Femoston
Hormones treatment after surgery.
Other Name: Hormones




Primary Outcome Measures :
  1. safety of intrauterine application of amnion membrane [ Time Frame: 3 months ]
    patients treated by amnion membrane following their hysteroscopic procedure were followed for immediate and late adverse effect: fever, abnormal vaginal discharge, pelvic pain, increased intrauterine adhesion formation upon follow up and changes in menstrual pattern.


Secondary Outcome Measures :
  1. efficacy of intrauterine application of amnion graft in reducing adhesion formation following hysteroscopic adhesiolysis. [ Time Frame: 3 months ]
    intrauterine adhesions were assessed and graded according to the American Fertility Society (AFS) score upon hysteroscopy follow up 4 and 12 weeks following initial treatment.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • patients scheduled for adhesiolysis of intrauterine adhesions
  • patients willing to undergo followed hysteroscopy about 4 and 12 weeks after the surgery to assess the reformation of intrauterine adhesions.
  • Written, informed consent obtained.

Exclusion Criteria:

  • ongoing pregnancy
  • Peroperative fever or infections
  • Malignancy
  • Precious pelvic inflammatory disease
  • Uterine fibroid (>3cm size)
  • endometriosis
  • Contraindications for anesthesia
  • Not able to read and/or understand informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02132104


Contacts
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Contact: Xuebing Peng, MD 008613901297392 peng_xue_bing@hotmail.com

Locations
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China
Fu Xing Hospital, Capital Medical University
Beijing, China, 100038
Contact: Shanshan Zheng    0086 10 88062032    fxyykjk@sina.com   
Contact: Qin Zhong    0086 10 88062944    fxyykjk@sina.com   
Principal Investigator: Xuebing Peng, MD         
Sub-Investigator: TC Li, PhD         
Sub-Investigator: Xiaoxia Peng, PhD         
Fu Xing Hospital, Capital Medical University
Beijing, China, 100038
Contact: Shanshan Zheng    0086 10 88062032    fxyykjk@sina.com   
Contact: Qin Zhong    008610 88062944    fxyykjk@sina.com   
Principal Investigator: Xuebing Peng, MD         
Sponsors and Collaborators
Capital Medical University
Investigators
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Study Director: TC Li, PhD Hysteroscopic Center, Fu Xing Hospital
Principal Investigator: Xuebing Peng, MD Hysteroscopic Center, Fu Xing Hospital
Study Chair: Enlan Xia, MD Hysteroscopic Center, Fu Xing Hospital
Publications:
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Responsible Party: XUEBING PENG, Associated Professor, Capital Medical University
ClinicalTrials.gov Identifier: NCT02132104    
Other Study ID Numbers: CMU-FXH-14-06
First Posted: May 7, 2014    Key Record Dates
Last Update Posted: October 21, 2014
Last Verified: October 2014
Keywords provided by XUEBING PENG, Capital Medical University:
Intrauterine adhesions
Asherman Syndrome
Amnion graft
Additional relevant MeSH terms:
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Tissue Adhesions
Cicatrix
Fibrosis
Pathologic Processes
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs