Clinical trial NCT02708277: Reproductive Outcome Affected by Two Adjunctive Treatments in Patients With Severe Intrauterine Adhesions
Official title: Reproductive Outcome Affected by Two Adjunctive Treatments in Patients With Infertility Due to Severe Intrauterine Adhesions.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asherman's Syndrome
Keywords: intrauterine contraceptive device
intrauterine balloon
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2016-03-15
Enrollment: 93
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Participants With Pregnancy in Loop-shaped Intrauterine Device Group and Intrauterine Balloon Group
timeFrame: three years
Secondary outcomes:
measure: Menstruation Pattern(Improvement or No Significant Change) of All Participants
timeFrame: Within the first 3 months after surgery
measure: Endometrial Thickness of All Participants in the Mid Menstrual Measured by Color Doppler Ultrasound
timeFrame: Within the first 3 months after surgery
measure: Number of Participants With Reformation of Intrauterine Adhesions in Loop-shaped Intrauterine Device Group and Intrauterine Balloon Group
timeFrame: Within the first 3 months after surgery
Other outcomes:
Locations:
Study officials:
affiliation: First Affiliated Hospital, Sun Yat-Sen University
name: Shuzhong Yao, professor
role: STUDY_DIRECTOR
References:
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.