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

Yuqing Chen

Status: Completed

Conditions: Asherman's Syndrome

Treatments: Device: intrauterine balloon (Cook Medical); Device: loop-shaped intrauterine contraceptive device

Study type: Interventional

Funder types: Other

Identifiers

NCT02708277

IUA-21

Details and patient eligibility

About

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.

Full 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.

Enrollment: 93 patients

Sex: Female

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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93 participants in 2 patient groups

Group A

Experimental group

Description:

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

Treatment:

Device: loop-shaped intrauterine contraceptive device

Group B

Experimental group

Description:

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

Treatment:

Device: intrauterine balloon (Cook Medical)