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Comparing the Efficacy of Two Methods in the Prevention of Adhesion Reformation After Hysteroscopic Adhesiolysis

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ClinicalTrials.gov Identifier: NCT03346317
Recruitment Status : Recruiting
First Posted : November 17, 2017
Last Update Posted : November 20, 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. Estrogen is also used for postoperative prevention of intrauterine adhesions. Intrauterine balloon can reduce the recurrence of adhesions after operation. Does the combination of balloon with amniotic products or estrogen can improve clinical outcomes? Therefore, this study was conducted.

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

Detailed Description:
Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double (participant and outcomes Assessor) Primary Purpose: Prevention

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 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 for the Therapy of Uterine Adhesion
Actual Study Start Date : November 16, 2017
Estimated Primary Completion Date : May 16, 2018
Estimated Study Completion Date : May 20, 2018


Arm Intervention/treatment
Experimental: dried biological amnion graft
patients, who are with IUA, treated by uterine application of disposable balloon uterine stent + amnion membrane 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 compare to Foley catheter.

Procedure: dried biological amnion graft
Uterine application of amnion membrane following hysteroscopic adhesiolysis. Other Name: Human amnion membrane

Experimental: estrogen
patients, who are with IUA, treated by uterine application of disposable balloon uterine stent+ 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 compare to Foley catheter.

Drug: estradiol valerate tablets+dydrogesterone tablets
oral estradiol valerate tablets+dydrogesterone tablets
Other Name: Progynova+dydrogesterone




Primary Outcome Measures :
  1. Incidence of adhesion information [ Time Frame: Within the first 3 months after surgery ]
    Intrauterine adhesions under hysteroscopy


Secondary Outcome Measures :
  1. Menstruation pattern [ Time Frame: Within the first 3 months after surgery ]
    menstrual volume which was assessed by pictorial blood loss assessment chart

  2. The change of AFS score [ Time Frame: Within the first 3 months after surgery ]
    The American Fertility Society ( AFS ) scoring system (1988 version). Scores of 1-4, 5-8, and 9-12 were mild, moderate, and severe adhesions, respectively.



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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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): NCT03346317


Contacts
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Contact: Zhu Ru, MD 13966636438 zhuru19790202@163.com
Contact: Wang Sha, MD 15201556908 wangsha1020@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    +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: NCT03346317     History of Changes
Other Study ID Numbers: No.5-20171111
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: November 20, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
hysteroscopy
Uterine stent
Estrogen
Amnion
Hysteroscopic Adhesiolysis
Additional relevant MeSH terms:
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Tissue Adhesions
Cicatrix
Fibrosis
Pathologic Processes
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol
Polyestradiol phosphate
Estrogens
Dydrogesterone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female
Progestins