NCT03346317

Comparing the Efficacy of Two Methods in the Prevention of Adhesion Reformation After Hysteroscopic Adhesiolysis

Randomized, Controlled Trial to Assess the Efficacy of Disposable Balloon Uterine Stent Combined With Estrogen or Dried Biological Amnion Graft for the Therapy of Uterine Adhesion

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Beijing Obstetrics and Gynecology Hospital · Academic / Other
• Sex: Female
• Age: 20 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

Asherman's syndrome is characterized by the presence of intrauterine adhesions (IUA) as well as symptoms such as amenorrhea, hypomenorrhea, pelvic pain, and infertility. The gold standard for the treatment of intrauterine adhesions is hysteroscopic intrauterine adhesions. The recurrence of intrauterine adhesions is a major challenge in clinical practice. It has been reported that dried biological aminion graft was used to prevent adhesion after the operation of intrauterine adhesions. Estrogen is also used for postoperative prevention of intrauterine adhesions. Intrauterine balloon can reduce the recurrence of adhesions after operation. Does the combination of balloon with amniotic products or estrogen can improve clinical outcomes? Therefore, this study was conducted.

Detailed description

Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double (participant and outcomes Assessor) Primary Purpose: Prevention

Conditions

• Intrauterine Adhesion

Interventions

Type	Name	Description
DEVICE	disposable balloon uterine stent	The disposable balloon uterine stent 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 Foley catheter.
PROCEDURE	dried biological amnion graft	Uterine application of amnion membrane following hysteroscopic adhesiolysis. Other Name: Human amnion membrane
DRUG	estradiol valerate tablets+dydrogesterone tablets	oral estradiol valerate tablets+dydrogesterone tablets

Timeline

• Start date: 2017-11-16
• Primary completion: 2018-05-16
• Completion: 2018-05-20
• First posted: 2017-11-17
• Last updated: 2017-11-20

Locations

1 site across 1 country: China