Autologous Platelet-Rich Plasma in the Management of Asherman Syndrome

Study Overview
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Brief Summary
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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
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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.

Official Title
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Platelet-Rich Plasma in the Management of Asherman Syndrome

Conditions
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Intrauterine Adhesion

Intervention / Treatment
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* Biological: platelet rich plasma
* Combination Product: amniotic membrane graft group
* Device: Intrauterine balloon


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Severe intrauterine synechia confirmed by hysteroscopy age group from 20 to 40 years Exclusion Criteria: Hemoglobin less than 11 g/dl Platelet less than 150000/mm3 Patients taking anticoagulants Patients taking NSAID in the 15 days prior to the procedure Active cervical or uterine infection

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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 Foley balloon catheter. in the second group, adhesiolysis will be followed by insertion of Foley balloon catheter covered by freeze-dried amniotic graft. In the third group, Adhesiolysis will be followed by insertion of Foley balloon catheter. All foley ballon removed 2 weeks postoperative. All patients will be given antibiotics and hormonal treatment. Also, they will be given low dose aspirin and sildenafil 50mg daily.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: platelet rich plasma group<br>intrauterine platelet rich plasma injection and intrauterine balloon insertion after hysteroscopic lysis of intrauterine adhesions | Biological: platelet rich plasma<br>* Platelet rich plasma and intrauterine balloon applied intrauterine after hysteroscopic adhesiolysis of intrauterine adhesions<br>|
| Other: amniotic membrane graft group<br>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<br>* amniotic membrane applied on the intrauterine balloon after hysteroscopic lysis of intrauterine adhesions<br>|
| Other: intrauterine balloon group<br>the clinician will perform hysteroscopic lysis of intrauterine adhesions followed by application of intrauterine balloon | Device: Intrauterine balloon<br>* intrauterine balloon applied intrauterine after hysteroscopic lysis of intrauterine adhesions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Grade of intrauterine adhesions | Grade of intrauterine adhesions | after one month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| menstruation | amount of menstrual blood change | within three months postoperative |