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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 Summary: 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.
Sponsor: Yuqing Chen

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

Original Primary Outcome: Number of participants with pregnancy in Group A and Group B [ Time Frame: three years ]

Current Secondary Outcome:

  • 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:

  • 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 ]


Information By: First Affiliated Hospital, Sun Yat-Sen University

Dates:
Date Received: March 4, 2016
Date Started: January 2011
Date Completion:
Last Updated: April 21, 2016
Last Verified: April 2016