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

November 14, 2017 updated by: Beijing Obstetrics and Gynecology Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Beijing Obstetrics and Gynecology Hospital, Capital Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Progynova
Drug: dydrogesterone Tablets
oral dydrogesterone Tablets
Other Names:
  • 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 Names:
  • Progynova
Drug: dydrogesterone Tablets
oral dydrogesterone Tablets
Other Names:
  • Duphaston

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
postoperation three months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pregnancy
Time Frame: postoperation one year
the number of biochemical pregnancy or clinical pregnancy
postoperation one year
Menstruation Pattern
Time Frame: postoperation three months
Amenorrhoea, hypomenorrhea, normal menstrual volume
postoperation three months
adhesion reformation
Time Frame: postoperation three months
Adhesion is seen under direct vision by hysteroscopy
postoperation three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Obstetrics and Gynecology Hospital

Investigators

  • Study Chair: Duan Hua, PhD, Beijing Obstetrics and Gynecology Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 31, 2017

Primary Completion (Anticipated)

October 25, 2018

Study Completion (Anticipated)

November 25, 2018

Study Registration Dates

First Submitted

October 20, 2017

First Submitted That Met QC Criteria

November 1, 2017

First Posted (Actual)

November 6, 2017

Study Record Updates

Last Update Posted (Actual)

November 17, 2017

Last Update Submitted That Met QC Criteria

November 14, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • No.4-20171020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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