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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
Sponsor:
Information provided by (Responsible Party):
Ahmed Mohamed Mahmoud Abd El-Wahab Torky, Ain Shams Maternity Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Intrauterine Adhesion Biological: Platelet Rich Plasma Device: Intrauterine Foley's Catheter Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adhesions

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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:

    1. Extent of cavity involved: ( <1/3, 1/3 - 2/3, >2/3 )
    2. Type of adhesions: (filmy, filmy to dense, dense)
    3. menstrual pattern (normal, hypomenorrhea, amenorrhea)


Secondary Outcome Measures :
  1. Return of menses [ Time Frame: Reassessed after one month ]
    Return/normalization of expected menses by history (yes/no)



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Ages Eligible for Study:   18 Years to 43 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Locations
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Egypt
Ain Shams University Maternity Hospital
Cairo, Egypt, 11357
Sponsors and Collaborators
Ain Shams Maternity Hospital
Investigators
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Study Chair: Mohamed I Amer, MD Professor
Study Director: Mortada E Ahmed, MD Lecturer
Study Director: Reda M Kamal, MD Lecturer
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Responsible Party: Ahmed Mohamed Mahmoud Abd El-Wahab Torky, Principal Investigator, Ain Shams Maternity Hospital
ClinicalTrials.gov Identifier: NCT03541746    
Other Study ID Numbers: PRP-HLIUA
First Posted: May 31, 2018    Key Record Dates
Last Update Posted: May 31, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tissue Adhesions
Cicatrix
Fibrosis
Pathologic Processes