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

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ClinicalTrials.gov Identifier: NCT02708277
Recruitment Status : Completed
First Posted : March 15, 2016
Results First Posted : May 27, 2016
Last Update Posted : May 27, 2016
Sponsor:
Information provided by (Responsible Party):
Yuqing Chen, First Affiliated Hospital, Sun Yat-Sen University

Tracking Information
First Submitted Date  ICMJE March 4, 2016
First Posted Date  ICMJE March 15, 2016
Results First Submitted Date  ICMJE March 22, 2016
Results First Posted Date  ICMJE May 27, 2016
Last Update Posted Date May 27, 2016
Study Start Date  ICMJE January 2011
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 21, 2016)
Number of Participants With Pregnancy in Loop-shaped Intrauterine Device Group and Intrauterine Balloon Group [ Time Frame: three years ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 9, 2016)
Number of participants with pregnancy in Group A and Group B [ Time Frame: three years ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 21, 2016)
  • 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
  • Endometrial Thickness of All Participants in the Mid Menstrual Measured by Color Doppler Ultrasound [ Time Frame: 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 9, 2016)
  • Menstruation Pattern(Improvement or No Significant Change) of All Participants [ Time Frame: 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 ]
  • Number of participants with reformation of intrauterine adhesions in Group A and Group B [ Time Frame: three years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Reproductive Outcome Affected by Two Adjunctive Treatments in Patients With Severe Intrauterine Adhesions
Official Title  ICMJE Reproductive Outcome Affected by Two Adjunctive Treatments in Patients With Infertility Due to Severe Intrauterine Adhesions.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Asherman's Syndrome
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Experimental: Group A
    At the end of the procedure the surgery loop-shaped intrauterine contraceptive device (IUCD) was placed in the uterine cavity.
    Intervention: Device: loop-shaped intrauterine contraceptive device
  • Experimental: Group B
    At the end of the procedure the surgery an intrauterine balloon (Cook Medical) was placed in the uterine cavity.
    Intervention: Device: intrauterine balloon (Cook Medical)
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 21, 2016)
93
Original Actual Enrollment  ICMJE
 (submitted: March 9, 2016)
82
Actual Study Completion Date  ICMJE March 2015
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02708277
Other Study ID Numbers  ICMJE IUA-21
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Yuqing Chen, First Affiliated Hospital, Sun Yat-Sen University
Study Sponsor  ICMJE Yuqing Chen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Shuzhong Yao, professor First Affiliated Hospital, Sun Yat-Sen University
PRS Account First Affiliated Hospital, Sun Yat-Sen University
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP