The Value of Using Platelet Rich Plasma After Hysteroscopic Lysis of Severe Intrauterine Adhesions
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|ClinicalTrials.gov Identifier: NCT03541746|
Recruitment Status : Completed
First Posted : May 31, 2018
Last Update Posted : May 31, 2018
|Condition or disease||Intervention/treatment||Phase|
|Intrauterine Adhesion||Biological: Platelet Rich Plasma Device: Intrauterine Foley's Catheter||Not Applicable|
In women undergoing hysteroscopic adhesiolysis, does postoperative use of platelet rich plasma decrease the recurrence of intrauterine adhesions?
In women undergoing hysteroscopic adhesiolysis for Asherman's syndrome, postoperative use of platelet rich plasma may decrease the recurrence of intrauterine adhesions.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||The Value of Using Platelet Rich Plasma After Hysteroscopic Lysis of Severe Intrauterine Adhesions (A Randomized Controlled Trial)|
|Actual Study Start Date :||April 1, 2017|
|Actual Primary Completion Date :||January 31, 2018|
|Actual Study Completion Date :||January 31, 2018|
Experimental: Study Group
Platelet Rich Plasma
Biological: Platelet Rich Plasma
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.
Active Comparator: Control Group
Intrauterine Foley's Catheter
Device: Intrauterine Foley's Catheter
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.
- Prevent recurrence of intrauterine adhesions [ Time Frame: Reassessed after one month ]
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)
- Return of menses [ Time Frame: Reassessed after one month ]Return/normalization of expected menses by history (yes/no)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03541746
|Ain Shams University Maternity Hospital|
|Cairo, Egypt, 11357|
|Study Chair:||Mohamed I Amer, MD||Professor|
|Study Director:||Mortada E Ahmed, MD||Lecturer|
|Study Director:||Reda M Kamal, MD||Lecturer|