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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

Brief Summary:
To estimate the efficacy and safety of dried biological amnion graft after hysteroscopic lysis of intrauterine adhesions.

Condition or disease Intervention/treatment Phase
Intrauterine Adhesions Procedure: dried biological amnion graft Device: Foley balloon Drug: estradiol valerate tablets+dydrogesterone Tablets Not Applicable

Detailed Description:
Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
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
Study Start Date : January 2013
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : June 2017


Arm Intervention/treatment
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.
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

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.
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




Primary Outcome Measures :
  1. second diagnostic hysteroscopy [ Time Frame: postoperation three to four months ]


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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

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): NCT02496052


Contacts
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Contact: Wang Xin, MD 13681401510 wx_0327@126.com
Contact: Gan Lu, MD 13552320665 gl19880508@163.com

Locations
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China, Beijing
Beijing Obstetrics and Gynecology Hospital,Capital Medical University Recruiting
Beijing, Beijing, China, 100006
Contact: Liu Zhen, M.D    +8613718210767    fcyykyb@163.com   
Sponsors and Collaborators
Beijing Obstetrics and Gynecology Hospital
Investigators
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Study Chair: Duan Hua, Ph.D Beijing Obstetrics and Gynecology Hospital
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Beijing Obstetrics and Gynecology Hospital
ClinicalTrials.gov Identifier: NCT02496052    
Other Study ID Numbers: 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 )
First Posted: July 14, 2015    Key Record Dates
Last Update Posted: July 17, 2015
Last Verified: July 2015
Keywords provided by Beijing Obstetrics and Gynecology Hospital:
amnion graft
New biological barrier system
Additional relevant MeSH terms:
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Tissue Adhesions
Cicatrix
Fibrosis
Pathologic Processes
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol
Polyestradiol phosphate
Dydrogesterone
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female
Progestins