NCT03731689

Treatment of Intrauterine Adhesions and Its Distribution of Genital Tract Flora

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: First Affiliated Hospital, Sun Yat-Sen University · Academic / Other
• Sex: Female
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study aims to investigate the treatment of intrauterine adhesion and the factors influencing its prognosis.

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.It is well established that the formation of intrauterine adhesion likely involves hypoxia, reduced neovascularization, and altered expression of adhesion associated cytokines, but the exact mechanisms are not well understood. Although excessive curettage is considered the primary cause, intrauterine adhesion is known to be associated with diverse non-traumatic factors, such as postabortal sepsis, puerperal sepsis and infections. Intrauterine adhesion separation surgery is the gold standard for the treatment of uterine adhesion. Although the success rate is as high as 95%, the patients with moderate or severe uterine adhesion have severe damage to the endometrial basement, poor regeneration of endometrial and gland, poor tolerance of endometrial and poor clinical prognosis. Even if all kinds of anti-adhesion measures are used comprehensively, the postoperative recurrence rate of patients with moderate and severe uterine adhesion is high.Therefore this study was conducted to investigate whether intrauterine lavage or intrauterine gel-injection therapy after surgery could reduce the recurrence of intrauterine adhesion, promote the endometrial growth and repair and improve the menstruation and reproductive prognosis for severe intrauterine adhesion, and we hypothesize that intrauterine adhesion may be related to changes in microbial flora in the reproductive tract.

Conditions

• Intrauterine Adhesions

Interventions

Type	Name	Description
DRUG	Intrauterine lavage therapy	Intrauterine lavage treatment was performed within 3 to 7 days after the first menstrual period after surgery.
DRUG	Intrauterine gel-injection therapy	Intrauterine gel-injection treatment was performed within 3 to 7 days after the first menstrual period after surgery.

Timeline

• Start date: 2018-05-01
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2018-11-06
• Last updated: 2018-11-06

Locations

1 site across 1 country: China