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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

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.

Condition or disease Intervention/treatment Phase
Intrauterine Adhesion Procedure: dried biological amnion graft Device: disposable balloon uterine stent Drug: estradiol valerate tablets Drug: dydrogesterone Tablets Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : October 31, 2017
Estimated Primary Completion Date : October 25, 2018
Estimated Study Completion Date : November 25, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adhesions

Arm Intervention/treatment
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.
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

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.
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. pregnancy [ Time Frame: postoperation one year ]
    the number of biochemical pregnancy or clinical pregnancy

  2. Menstruation Pattern [ Time Frame: postoperation three months ]
    Amenorrhoea, hypomenorrhea, normal menstrual volume

  3. adhesion reformation [ Time Frame: postoperation three months ]
    Adhesion is seen under direct vision by hysteroscopy



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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT03329898


Contacts
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Contact: Zhu Ru, MD 13966636438 zhuru19790202@163.com
Contact: Wang Sha, PhD 15201556908 wangsha1020@163.com

Locations
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China
Beijing Obstetrics and Gynecology Hospital, Capital Medical University Recruiting
Beijing, China
Contact: Liu Zhen, MD    +8613718210767    fcyykyb@163.com   
Sponsors and Collaborators
Beijing Obstetrics and Gynecology Hospital
Investigators
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Study Chair: Duan Hua, PhD Beijing Obstetrics and Gynecology Hospital
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Responsible Party: Beijing Obstetrics and Gynecology Hospital
ClinicalTrials.gov Identifier: NCT03329898    
Other Study ID Numbers: No.4-20171020
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Beijing Obstetrics and Gynecology Hospital:
Asherman syndrome
uterine stent
hysteroscopy
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