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Clinical Trials/NCT02708277
NCT02708277CompletedNot Applicable

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

Yuqing Chen0 sites93 target enrollmentStarted: January 1, 2011Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
93
Primary Endpoint
Number of Participants With Pregnancy in Loop-shaped Intrauterine Device Group and Intrauterine Balloon Group

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Sex
Female
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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

Time Frame: three years

Secondary Outcomes

  • Menstruation Pattern(Improvement or No Significant Change) of All Participants(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(Within the first 3 months after surgery)
  • Endometrial Thickness of All Participants in the Mid Menstrual Measured by Color Doppler Ultrasound(Within the first 3 months after surgery)

Investigators

Sponsor
Yuqing Chen
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Yuqing Chen

Associate chief physician

First Affiliated Hospital, Sun Yat-Sen University

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