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Autologous Platelet-Rich Plasma in the Management of Asherman Syndrome

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ClinicalTrials.gov Identifier: NCT04308811
Recruitment Status : Completed
First Posted : March 16, 2020
Last Update Posted : March 16, 2020
Sponsor:
Information provided by (Responsible Party):
Mohamed I Amer, Ain Shams University

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Intrauterine Adhesion Biological: platelet rich plasma Combination Product: amniotic membrane graft group Device: Intrauterine balloon Phase 2

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Platelet-Rich Plasma in the Management of Asherman Syndrome
Actual Study Start Date : August 10, 2019
Actual Primary Completion Date : February 20, 2020
Actual Study Completion Date : February 20, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adhesions

Arm Intervention/treatment
platelet rich plasma group
intrauterine platelet rich plasma injection and intrauterine balloon insertion after hysteroscopic lysis of intrauterine adhesions
Biological: platelet rich plasma
Platelet rich plasma and intrauterine balloon applied intrauterine after hysteroscopic adhesiolysis of intrauterine adhesions

amniotic membrane graft group
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
amniotic membrane applied on the intrauterine balloon after hysteroscopic lysis of intrauterine adhesions

intrauterine balloon group
the clinician will perform hysteroscopic lysis of intrauterine adhesions followed by application of intrauterine balloon
Device: Intrauterine balloon
intrauterine balloon applied intrauterine after hysteroscopic lysis of intrauterine adhesions




Primary Outcome Measures :
  1. Grade of intrauterine adhesions [ Time Frame: after one month ]
    Grade of intrauterine adhesions


Secondary Outcome Measures :
  1. menstruation [ Time Frame: within three months postoperative ]
    amount of menstrual blood change



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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT04308811


Locations
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Egypt
Endoscopy unit, Ain shams university Maternity hospital
Cairo, Egypt
Sponsors and Collaborators
Ain Shams University
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Responsible Party: Mohamed I Amer, Professor, Ain Shams University
ClinicalTrials.gov Identifier: NCT04308811    
Other Study ID Numbers: ASU456
First Posted: March 16, 2020    Key Record Dates
Last Update Posted: March 16, 2020
Last Verified: March 2020

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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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Gynatresia