NCT04308811

Autologous Platelet-Rich Plasma in the Management of Asherman Syndrome

Platelet-Rich Plasma in the Management of Asherman Syndrome

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Ain Shams University · Academic / Other
• Sex: Female
• Age: 20 Years – 40 Years
• Healthy volunteers: Accepted

Summary

The aim of the study is to find out the benefit of the platelet-rich plasma in preventing reformation of intrauterine adhesions after adhesiolysis in cases of Asherman syndrome

Detailed description

Patients fulfilling criteria will be randomized into three equal groups. The patients who are diagnosed previously with severe AS will choose an envelope which determines the treatment method. There will be 60 envelops assigning for the groups mixed together in one box. This will ensure a randomized allocation of patients to either group of this study. Hysteroscopy adhesiolysis will be done to all participants in the study. in the first group, Adhesiolysis will be followed by intrauterine use of PRP then insertion of intrauterine Foley balloon catheter that will be inflated and left for 2 weeks. in the second group, adhesiolysis will be followed by insertion of intrauterine Foley balloon catheter covered by freeze-dried amniotic graft and will be inflated and left for 2 weeks. In the third group, Adhesiolysis will be followed by insertion of intrauterine Foley balloon catheter that will be inflated and left for 2 weeks. All patients will be given antibiotics and hormonal treatment. Also, they will be given low dose aspirin and sildenafil 50mg daily.

Conditions

• Intrauterine Adhesion

Interventions

Type	Name	Description
BIOLOGICAL	platelet rich plasma	Platelet rich plasma and intrauterine balloon applied intrauterine after hysteroscopic adhesiolysis of intrauterine adhesions
COMBINATION_PRODUCT	amniotic membrane graft group	amniotic membrane applied on the intrauterine balloon after hysteroscopic lysis of intrauterine adhesions
DEVICE	Intrauterine balloon	intrauterine balloon applied intrauterine after hysteroscopic lysis of intrauterine adhesions

Timeline

• Start date: 2019-08-10
• Primary completion: 2020-02-20
• Completion: 2020-02-20
• First posted: 2020-03-16
• Last updated: 2020-03-16

Locations

1 site across 1 country: Egypt