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

Asherman's Syndrome Clinical Trial

— ROABTIPWSIUA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02708277
• Other study ID #: IUA-21
• Status: Completed
• Phase: N/A
• First received: March 4, 2016
• Last updated: March 14, 2016
• Start date: January 2011
• Est. completion date: March 2015

Study information

• Verified date: March 2016
• Source: First Affiliated Hospital, Sun Yat-Sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Guangdong Province
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asherman's Syndrome

Intervention

Device:
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Yuqing Chen

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with pregnancy in Group A and Group B		three years	No
Secondary	Menstruation pattern(improvement or No significant change) of all participants	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	Within the first 3 months after surgery	No
Secondary	Endometrial thickness of all participants in the mid menstrual measured by color Doppler ultrasound		Within the first 3 months after surgery	No
Secondary	Number of participants with reformation of intrauterine adhesions in Group A and Group B		three years	No