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

Primary Purpose

Asherman's Syndrome

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
loop-shaped intrauterine contraceptive device
intrauterine balloon (Cook Medical)
Sponsored by
Yuqing Chen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asherman's Syndrome focused on measuring intrauterine contraceptive device, intrauterine balloon

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Group A

    Group B

    Arm Description

    At the end of the procedure the surgery loop-shaped intrauterine contraceptive device (IUCD) was placed in the uterine cavity.

    At the end of the procedure the surgery an intrauterine balloon (Cook Medical) was placed in the uterine cavity.

    Outcomes

    Primary Outcome Measures

    Number of Participants With Pregnancy in Loop-shaped Intrauterine Device Group and Intrauterine Balloon Group

    Secondary Outcome Measures

    Menstruation Pattern(Improvement or No Significant Change) of All Participants
    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
    Endometrial Thickness of All Participants in the Mid Menstrual Measured by Color Doppler Ultrasound
    Number of Participants With Reformation of Intrauterine Adhesions in Loop-shaped Intrauterine Device Group and Intrauterine Balloon Group

    Full Information

    First Posted
    March 4, 2016
    Last Updated
    April 21, 2016
    Sponsor
    Yuqing Chen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02708277
    Brief Title
    Reproductive Outcome Affected by Two Adjunctive Treatments in Patients With Severe Intrauterine Adhesions
    Acronym
    ROABTIPWSIUA
    Official Title
    Reproductive Outcome Affected by Two Adjunctive Treatments in Patients With Infertility Due to Severe Intrauterine Adhesions.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2011 (undefined)
    Primary Completion Date
    March 2015 (Actual)
    Study Completion Date
    March 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Yuqing Chen

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Asherman's Syndrome
    Keywords
    intrauterine contraceptive device, intrauterine balloon

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    93 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group A
    Arm Type
    Experimental
    Arm Description
    At the end of the procedure the surgery loop-shaped intrauterine contraceptive device (IUCD) was placed in the uterine cavity.
    Arm Title
    Group B
    Arm Type
    Experimental
    Arm Description
    At the end of the procedure the surgery an intrauterine balloon (Cook Medical) was placed in the uterine cavity.
    Intervention Type
    Device
    Intervention Name(s)
    loop-shaped intrauterine contraceptive device
    Intervention Description
    Intrauterine contraceptive device can temporary protective layer between the endometrium wound during the most critical three weeks after the surgery to prevent adhesion reformation.
    Intervention Type
    Device
    Intervention Name(s)
    intrauterine balloon (Cook Medical)
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Number of Participants With Pregnancy in Loop-shaped Intrauterine Device Group and Intrauterine Balloon Group
    Time Frame
    three years
    Secondary Outcome Measure Information:
    Title
    Menstruation Pattern(Improvement or No Significant Change) of All Participants
    Description
    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
    Time Frame
    Within the first 3 months after surgery
    Title
    Endometrial Thickness of All Participants in the Mid Menstrual Measured by Color Doppler Ultrasound
    Time Frame
    Within the first 3 months after surgery
    Title
    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

    10. Eligibility

    Sex
    Female
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Shuzhong Yao, professor
    Organizational Affiliation
    First Affiliated Hospital, Sun Yat-Sen University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    Citations:
    PubMed Identifier
    12834941
    Citation
    Orhue AA, Aziken ME, Igbefoh JO. A comparison of two adjunctive treatments for intrauterine adhesions following lysis. Int J Gynaecol Obstet. 2003 Jul;82(1):49-56. doi: 10.1016/s0020-7292(03)00030-4.
    Results Reference
    result

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

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