The Efficacy of Estrogen Therapy Against Adhesion Reformation After Hysteroscopic Adhesiolysis

November 20, 2017 updated by: Beijing Obstetrics and Gynecology Hospital

Randomized, Controlled Trial to Assess the Efficacy of Estrogen Therapy Combined With Disposable Balloon Uterine Stent and 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. Intrauterine balloon has been used for the prevention of intrauterine adhesions. It has been reported that dried biological amnion 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. Disposable balloon uterine stent，which is an innovative intrauterine balloon，is specially designed to fit into the cavity of the uterus. Does Disposable balloon uterine stent and amniotic products combine estrogen therapy improve clinical outcomes? Therefore, this study was conducted.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

100

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 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Uterine cavity barrier only
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 dried biological amnion graft following hysteroscopic adhesiolysis.

Other Name: Human amnion membrane

Other Names:
  • amnion membrane
Experimental: hormone
patients, who are with IUA, treated by uterine application of disposable balloon uterine stent+ amnion membrane+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 Names:
  • Progynova+dydrogesterone
Procedure: dried biological amnion graft

Uterine application of dried biological amnion graft following hysteroscopic adhesiolysis.

Other Name: Human amnion membrane

Other Names:
  • amnion membrane

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of adhesion information
Time Frame: Within the first 3 months after surgery
Intrauterine adhesions under hysteroscopy
Within the first 3 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Menstruation Pattern
Time Frame: Within the first 3 months after surgery
menstrual volume which was assessed by pictorial blood loss assessment chart
Within the first 3 months after surgery
The change of AFS score
Time Frame: Within the first 3 months after surgery
he American Fertility Society ( AFS ) scoring system (1988 version). Scores of 1-4, 5-8, and 9-12 were mild, moderate, and severe adhesions, respectively.
Within the first 3 months after surgery

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, MD, 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 (Anticipated)

November 21, 2017

Primary Completion (Anticipated)

November 21, 2018

Study Completion (Anticipated)

November 22, 2018

Study Registration Dates

First Submitted

November 20, 2017

First Submitted That Met QC Criteria

November 20, 2017

First Posted (Actual)

November 22, 2017

Study Record Updates

Last Update Posted (Actual)

November 22, 2017

Last Update Submitted That Met QC Criteria

November 20, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • No.6-20171120

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

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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