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Autologous Platelet-Rich Plasma in the Management of Asherman Syndrome

Primary Purpose

Intrauterine Adhesion

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
platelet rich plasma
amniotic membrane graft group
Intrauterine balloon
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intrauterine Adhesion

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Endoscopy unit, Ain shams university Maternity hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

platelet rich plasma group

amniotic membrane graft group

intrauterine balloon group

Arm Description

intrauterine platelet rich plasma injection and intrauterine balloon insertion after hysteroscopic lysis of intrauterine adhesions

the clinician will perform hysteroscopic lysis of intrauterine adhesions followed by application of intrauterine balloon covered by freeze-dried amniotic membranes.

the clinician will perform hysteroscopic lysis of intrauterine adhesions followed by application of intrauterine balloon

Outcomes

Primary Outcome Measures

Grade of intrauterine adhesions
Grade of intrauterine adhesions

Secondary Outcome Measures

menstruation
amount of menstrual blood change

Full Information

First Posted
December 14, 2018
Last Updated
March 12, 2020
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT04308811
Brief Title
Autologous Platelet-Rich Plasma in the Management of Asherman Syndrome
Official Title
Platelet-Rich Plasma in the Management of Asherman Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
August 10, 2019 (Actual)
Primary Completion Date
February 20, 2020 (Actual)
Study Completion Date
February 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intrauterine Adhesion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
platelet rich plasma group
Arm Type
Other
Arm Description
intrauterine platelet rich plasma injection and intrauterine balloon insertion after hysteroscopic lysis of intrauterine adhesions
Arm Title
amniotic membrane graft group
Arm Type
Other
Arm Description
the clinician will perform hysteroscopic lysis of intrauterine adhesions followed by application of intrauterine balloon covered by freeze-dried amniotic membranes.
Arm Title
intrauterine balloon group
Arm Type
Other
Arm Description
the clinician will perform hysteroscopic lysis of intrauterine adhesions followed by application of intrauterine balloon
Intervention Type
Biological
Intervention Name(s)
platelet rich plasma
Intervention Description
Platelet rich plasma and intrauterine balloon applied intrauterine after hysteroscopic adhesiolysis of intrauterine adhesions
Intervention Type
Combination Product
Intervention Name(s)
amniotic membrane graft group
Intervention Description
amniotic membrane applied on the intrauterine balloon after hysteroscopic lysis of intrauterine adhesions
Intervention Type
Device
Intervention Name(s)
Intrauterine balloon
Intervention Description
intrauterine balloon applied intrauterine after hysteroscopic lysis of intrauterine adhesions
Primary Outcome Measure Information:
Title
Grade of intrauterine adhesions
Description
Grade of intrauterine adhesions
Time Frame
after one month
Secondary Outcome Measure Information:
Title
menstruation
Description
amount of menstrual blood change
Time Frame
within three months postoperative

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Endoscopy unit, Ain shams university Maternity hospital
City
Cairo
Country
Egypt

12. IPD Sharing Statement

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Autologous Platelet-Rich Plasma in the Management of Asherman Syndrome

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