Efficiency of Amnion Graft to Prevent Intrauterine Adhesions After Hysteroscopic Surgery

October 20, 2014 updated by: XUEBING PENG, Capital Medical University

Amnion Graft for Preventing Intrauterine Adhesions Following Hysteroscopic Surgery

The purpose of the study is to evaluate whether human amnion graft reduces the reformation of severe intrauterine adhesions (IUA) following hysteroscopic adhesiolysis.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Background

IUA is a consequence of trauma to the endometrium, producing partial or complete obliteration in the uterine cavity and/or the cervical canal, resulting in conditions such as menstrual abnormalities, infertility, and recurrent pregnancy loss. The outcome of hysteroscopic adhesiolysis for IUA is significantly affected by recurrence of intrauterine adhesions. The IUA research should be directed toward reduction of adhesion reformation with a view to improve outcome.

The reformation of intrauterine adhesions appears to be directly related to the severity of the adhesions. It has been reported that the recurrence rate for intrauterine adhesions ranges from 3.1% to 23.5% among all cases of intrauterine adhesions and from 20% to 62.5% in those with severe adhesions.

In this study, considering the high recurrent rate in severe IUA, investigator will focus on severe IUA cases.

Up to now several strategies are commonly employed by various investigators after division of intrauterine adhesions:

  1. Physical barriers have been used to promote regeneration of the endometrium and prevention of adhesions. The physical barriers include an intrauterine device (IUD), a Foley catheter, a number of modifications of hyaluronic acid and Auto-cross-linked hyaluronic acid gel.
  2. Hormonal treatment has been used to promote regeneration of the endometrium.
  3. Antibiotic therapy has been used to prevent infection which is a potent trigger for adhesion formation/reformation.
  4. Various medications have been described to increase vascular flow to endometrium, such as asprin, nitroglycerine and sildenafil citrate.

There is published data (Amer et al, 2010), which based on a plot prospective, randomised, comparative study that grafting of either fresh or dried amnion is a promising adjunctive procedure for decreasing recurrence of adhesions and encouraging endometrial regeneration after hysteroscopic lysis of severe intrauterine adhesions. However, the study had a small number of patients, the valid conclusion can not be drawn.

In this study, the aim is to compare the safety and the efficacy of insertion of intrauterine balloon + hormonal treatment with or without grafting amnion to prevent intrauterine adhesion formation/reformation following division of intrauterine adhesions.

Study Design

Patients with severe IUA are enrolled according to the classification of intrauterine adhesion by American Fertility Society.

208 patients with severe IUA were chosen at random and divided equally into those who received amnion graft, following hysteroscopic adhesiolysis (treatment groups) and to those who did not receive the amnion graft (control groups).

Intervention

Following hysteroscopic adhesiolysis, patients will be randomised to have a Foley balloon with or without amnion graft into the uterine cavity. Hormones therapy has been used after surgical treatment both in treatment groups and control groups. A second look and a third look hysteroscopy will be performed about 4 and 12 weeks after the initial operative hysteroscopy. The amount of adhesions, if any, during the initial and reexamine hysteroscopies will be scored.

Power calculation

The investigators' retrospective pilot study data showed that the recurrent rate of severe IUA is around 30% in amnion treatment groups, and around 47.5% in control groups. According to these data, investigators calculated the sample sizes of this study by using Cochran-Mantel-Haenszel test with software PASS 11. Investigators will recruit 104 patients in each group.

Group sample sizes of 104 in group one and 104 in group two achieve 85% power to detect a difference between the group proportions of -0.2000. The group two proportion is 0.5000. The group one proportion is assumed to be 0.5000 under the null hypothesis and 0.3000 under the alternative hypothesis. The test statistic used is the two-sided Z test (unpooled). The significance level of the test was targeted at 0.0500. The significance level actually achieved by this design is not available.

Statistics

Safety and efficacy were evaluated by software NCSS-PASS, using Two Independent Proportions (Non-Null Case) Power Analysis.

Study Type

Interventional

Enrollment (Anticipated)

208

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 Locations

  • China
      • Beijing, China, 100038
        • Fu Xing Hospital, Capital Medical University
        • Contact:
        • Principal Investigator:
          • Xuebing Peng, MD
        • 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

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • patients scheduled for adhesiolysis of intrauterine adhesions
  • patients willing to undergo followed hysteroscopy about 4 and 12 weeks after the surgery to assess the reformation of intrauterine adhesions.
  • Written, informed consent obtained.

Exclusion Criteria:

  • ongoing pregnancy
  • Peroperative fever or infections
  • Malignancy
  • Precious pelvic inflammatory disease
  • Uterine fibroid (>3cm size)
  • endometriosis
  • Contraindications for anesthesia
  • Not able to read and/or understand informed consent.

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: amnion graft in severe IUA
patients, who are with severe IUA, treated by uterine application of amnion membrane + Foley balloon+ hormones (Femoston) following hysteroscopic adhesiolysis.
Procedure: Uterine application of amnion membrane
Uterine application of amnion membrane following hysteroscopic adhesiolysis.
Other Names:
  • Human amnion membrane
Device: Foley balloon
Uterine application of Foley balloon
Drug: Femoston
Hormones treatment after surgery.
Other Names:
  • Hormones
Sham Comparator: non-amnion graft in severe IUA
patients, who are with severe IUA, treated by Foley balloon+ hormones (Femoston) following hysteroscopic adhesiolysis.
Device: Foley balloon
Uterine application of Foley balloon
Drug: Femoston
Hormones treatment after surgery.
Other Names:
  • Hormones

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
safety of intrauterine application of amnion membrane
Time Frame: 3 months
patients treated by amnion membrane following their hysteroscopic procedure were followed for immediate and late adverse effect: fever, abnormal vaginal discharge, pelvic pain, increased intrauterine adhesion formation upon follow up and changes in menstrual pattern.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
efficacy of intrauterine application of amnion graft in reducing adhesion formation following hysteroscopic adhesiolysis.
Time Frame: 3 months
intrauterine adhesions were assessed and graded according to the American Fertility Society (AFS) score upon hysteroscopy follow up 4 and 12 weeks following initial treatment.
3 months

Collaborators and Investigators

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

Sponsor

Capital Medical University

Investigators

  • Study Director: TC Li, PhD, Hysteroscopic Center, Fu Xing Hospital
  • Principal Investigator: Xuebing Peng, MD, Hysteroscopic Center, Fu Xing Hospital
  • Study Chair: Enlan Xia, MD, Hysteroscopic Center, Fu Xing Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

November 1, 2014

Primary Completion (Anticipated)

August 1, 2016

Study Completion (Anticipated)

November 1, 2016

Study Registration Dates

First Submitted

May 2, 2014

First Submitted That Met QC Criteria

May 6, 2014

First Posted (Estimate)

May 7, 2014

Study Record Updates

Last Update Posted (Estimate)

October 21, 2014

Last Update Submitted That Met QC Criteria

October 20, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMU-FXH-14-06

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.

Clinical Trials on Intrauterine Adhesions

Clinical Trials on Uterine application of amnion membrane

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Georgia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe