A Phase 2 interventional study of platelet rich plasma and amniotic membrane graft group in Intrauterine Adhesion, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to female participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-16.
Sponsored by Ain Shams University · Phase 2, Interventional, and Treatment
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
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.
49 studies on the registry are indexed under Gynatresia; 17 are open to participants now.
This study's enrollment of 60 is below the median of 95 across 41 interventional studies indexed under Gynatresia.
Browse Gynatresia studies →Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.
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Inclusion Criteria: Severe intrauterine synechia confirmed by hysteroscopy
Exclusion Criteria:
intrauterine platelet rich plasma injection and intrauterine balloon insertion after hysteroscopic lysis of intrauterine adhesions
Biological: platelet rich plasma
the clinician will perform hysteroscopic lysis of intrauterine adhesions followed by application of intrauterine balloon covered by freeze-dried amniotic membranes.
Combination Product: amniotic membrane graft group
the clinician will perform hysteroscopic lysis of intrauterine adhesions followed by application of intrauterine balloon
Device: Intrauterine balloon
Platelet rich plasma and intrauterine balloon applied intrauterine after hysteroscopic adhesiolysis of intrauterine adhesions
amniotic membrane applied on the intrauterine balloon after hysteroscopic lysis of intrauterine adhesions
intrauterine balloon applied intrauterine after hysteroscopic lysis of intrauterine adhesions
Grade of intrauterine adhesions
Grade of intrauterine adhesions
Time frame: after one month
menstruation
amount of menstrual blood change
Time frame: within three months postoperative
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Ain Shams University