The Value of Using Platelet Rich Plasma After Hysteroscopic Lysis of Severe Intrauterine Adhesions

Study Overview
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Brief Summary
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The aim of present study is to evaluate the effect of the use of platelet rich plasma in decreasing recurrence of intrauterine adhesions after its lysis.

Detailed Description
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Research question: In women undergoing hysteroscopic adhesiolysis, does postoperative use of platelet rich plasma decrease the recurrence of intrauterine adhesions? Research hypothesis: In women undergoing hysteroscopic adhesiolysis for Asherman's syndrome, postoperative use of platelet rich plasma may decrease the recurrence of intrauterine adhesions.

Official Title
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The Value of Using Platelet Rich Plasma After Hysteroscopic Lysis of Severe Intrauterine Adhesions (A Randomized Controlled Trial)

Conditions
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Intrauterine Adhesion

Intervention / Treatment
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* Biological: Platelet Rich Plasma
* Device: Intrauterine Foley's Catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infertility due to Asherman's syndrome with history of hypomenorrhea or amenorrhea and infertility and evaluated by office hysteroscopy to confirm the presence of sever adhesions according to American fertility society. Exclusion Criteria: Hb < 11 g/dL, platelets < 150.000/mm3 Patient taking anticoagulant. Patient taking NSAID in the 10 days before procedure. Any significant comorbidity or psychiatric disorder that would compromise patient's consent. Active cervical or uterine infection.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 43 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Group<br>Platelet Rich Plasma | Biological: Platelet Rich Plasma<br>* After hysteroscopic adhesiolysis, 30 patients will undergo once injection of 5ml PRP into the wall then lining the uterine cavity by 5ml platelet rich plasma gel. Finally, Foley balloon catheter will be inserted intrauterine then inflated and cutting its stem and to be left for two weeks.<br>|
| Active Comparator: Control Group<br>Intrauterine Foley's Catheter | Device: Intrauterine Foley's Catheter<br>* After hysteroscopic adhesiolysis, 30 patients will undergo intrauterine insertion of one inflated Foley balloon catheter with cutting its stem only to be left for two weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevent recurrence of intrauterine adhesions | Prevent recurrence of intrauterine adhesions after hysteroscopic adhesiolysis assessed by office hysteroscopy according to American Fertility Society adhesion score: Extent of cavity involved: ( <1/3, 1/3 - 2/3, >2/3 ) Type of adhesions: (filmy, filmy to dense, dense) menstrual pattern (normal, hypomenorrhea, amenorrhea) | Reassessed after one month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Return of menses | Return/normalization of expected menses by history (yes/no) | Reassessed after one month |