Autologous Platelet-Rich Plasma in the Management of Asherman Syndrome

March 12, 2020 updated by: Mohamed I Amer, Ain Shams University

Platelet-Rich Plasma in the Management of Asherman Syndrome

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

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Cairo, Egypt
        • Endoscopy unit, Ain shams university Maternity hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: platelet rich plasma group
intrauterine platelet rich plasma injection and intrauterine balloon insertion after hysteroscopic lysis of intrauterine adhesions
Platelet rich plasma and intrauterine balloon applied intrauterine after hysteroscopic adhesiolysis of intrauterine adhesions
Other: 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.
amniotic membrane applied on the intrauterine balloon after hysteroscopic lysis of intrauterine adhesions
Other: intrauterine balloon group
the clinician will perform hysteroscopic lysis of intrauterine adhesions followed by application of intrauterine balloon
intrauterine balloon applied intrauterine after hysteroscopic lysis of intrauterine adhesions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Grade of intrauterine adhesions
Time Frame: after one month
Grade of intrauterine adhesions
after one month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
menstruation
Time Frame: within three months postoperative
amount of menstrual blood change
within three months postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 10, 2019

Primary Completion (Actual)

February 20, 2020

Study Completion (Actual)

February 20, 2020

Study Registration Dates

First Submitted

December 14, 2018

First Submitted That Met QC Criteria

March 12, 2020

First Posted (Actual)

March 16, 2020

Study Record Updates

Last Update Posted (Actual)

March 16, 2020

Last Update Submitted That Met QC Criteria

March 12, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASU456

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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