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

NCT ID: NCT02708277

Last Updated: 2016-05-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 93 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2015-03-31

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.

Conditions

Asherman's Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group A

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

Group Type: EXPERIMENTAL

loop-shaped intrauterine contraceptive device

Intervention Type: 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.

Group B

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

Group Type: EXPERIMENTAL

intrauterine balloon (Cook Medical)

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Yuqing Chen

OTHER

Sponsor Role: lead

Responsible Party

Yuqing Chen

Associate chief physician

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Shuzhong Yao, professor

Role: STUDY_DIRECTOR

First Affiliated Hospital, Sun Yat-Sen University

References

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.

Reference Type: RESULT

PMID: 12834941 (View on PubMed)

Other Identifiers

IUA-21

Identifier Type: -

Identifier Source: org_study_id