Reproductive Outcome Affected by Two Adjunctive Treatments in Patients With Severe Intrauterine Adhesions (ROABTIPWSIUA)

April 21, 2016 updated by: Yuqing Chen

Reproductive Outcome Affected by Two Adjunctive Treatments in Patients With Infertility Due to Severe Intrauterine Adhesions.

The purpose of this study is to compare the outcome of loop intrauterine contraceptive device and heart-shaped intrauterine balloon for the adjunctive treatment of severe intrauterine adhesions in patients with infertility.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Intrauterine adhesion, also known as Asherman's syndrome, is the partial or complete occlusion of the uterine cavity as a result of endometrium damage. Most intrauterine adhesions patients manifest amenorrhea, reduced menstrual pattern, infertility, and intrauterine growth restriction, which seriously affect their reproductive health. Currently, hysteroscopy is the preferred method of intrauterine adhesions diagnosis and treatment. However, because intrauterine adhesions patients generally have poor endometrium repair capability, the incidence rate of reformation of intrauterine adhesions ranging from 20%-62.5% in those with severe adhesions. The successful pregnancy rate after treatment in severe Asherman's syndrome is reported to be consistently lower, only 33%. The prevention of intrauterine adhesions recurrence after trans-cervical resection of adhesion is clinically important but difficult. Therefore, this study was conducted.

Study Type

Interventional

Enrollment (Actual)

93

Phase

  • Not Applicable

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Clinical diagnosis of severe intrauterine adhesions
  • infertility

Exclusion Criteria:

  • endometrial tuberculosis
  • grossly abnormal semen analysis
  • ovarian failure, hydrosalpinx fluid
  • patients who did not proceed to second-look hysteroscopy within the specified time frame
  • Women with no desire to pregnancy

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
At the end of the procedure the surgery loop-shaped intrauterine contraceptive device (IUCD) was placed in the uterine cavity.
Device: loop-shaped intrauterine contraceptive device
Intrauterine contraceptive device can temporary protective layer between the endometrium wound during the most critical three weeks after the surgery to prevent adhesion reformation.
Experimental: Group B
At the end of the procedure the surgery an intrauterine balloon (Cook Medical) was placed in the uterine cavity.
Device: intrauterine balloon (Cook Medical)
The balloons used in this study 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 loop-shaped intrauterine contraceptive device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants With Pregnancy in Loop-shaped Intrauterine Device Group and Intrauterine Balloon Group
Time Frame: three years
three years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Menstruation Pattern(Improvement or No Significant Change) of All Participants
Time Frame: Within the first 3 months after surgery
Comparing with preoperative and postoperative menstrual duration, numbers of sanitary napkin using and wet area ratio of sanitary napkin to judgment whether menstrual quantity is improvement in patients
Within the first 3 months after surgery
Endometrial Thickness of All Participants in the Mid Menstrual Measured by Color Doppler Ultrasound
Time Frame: Within the first 3 months after surgery
Within the first 3 months after surgery
Number of Participants With Reformation of Intrauterine Adhesions in Loop-shaped Intrauterine Device Group and Intrauterine Balloon Group
Time Frame: Within the first 3 months after surgery
Within the first 3 months after surgery

Collaborators and Investigators

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

Sponsor

Yuqing Chen

Investigators

  • Study Director: Shuzhong Yao, professor, First Affiliated Hospital, Sun Yat-Sen University

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

January 1, 2011

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

March 4, 2016

First Submitted That Met QC Criteria

March 9, 2016

First Posted (Estimate)

March 15, 2016

Study Record Updates

Last Update Posted (Estimate)

May 27, 2016

Last Update Submitted That Met QC Criteria

April 21, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IUA-21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

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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