NCT02496052

The Efficacy and Safety of the Dried Biological Amnion Graft in Patients With Intrauterine Adhesions

The Efficacy and Safety of the Dried Biological Amnion Graft Following Hysteroscopic Lysis for the Prevention of Postoperative Adhesions in Patients With Intrauterine Adhesions

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Beijing Obstetrics and Gynecology Hospital · Academic / Other
• Sex: Female
• Age: 20 Years – 40 Years
• Healthy volunteers: Accepted

Summary

To estimate the efficacy and safety of dried biological amnion graft after hysteroscopic lysis of intrauterine adhesions.

Detailed description

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

Conditions

• Intrauterine Adhesions

Interventions

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

Timeline

• Start date: 2013-01-01
• Primary completion: 2017-01-01
• Completion: 2017-06-01
• First posted: 2015-07-14
• Last updated: 2015-07-17

Locations

1 site across 1 country: China