Autologous Platelet-Rich Plasma in the Management of Asherman Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-10

Study Completion Date

2020-02-20

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Intrauterine Adhesion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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platelet rich plasma group

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

Group Type OTHER

platelet rich plasma

Intervention Type BIOLOGICAL

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.

Group Type OTHER

amniotic membrane graft group

Intervention Type COMBINATION_PRODUCT

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

Group Type OTHER

Intrauterine balloon

Intervention Type DEVICE

intrauterine balloon applied intrauterine after hysteroscopic lysis of intrauterine adhesions

Interventions

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platelet rich plasma

Platelet rich plasma and intrauterine balloon applied intrauterine after hysteroscopic adhesiolysis of intrauterine adhesions

Intervention Type BIOLOGICAL

amniotic membrane graft group

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

Intervention Type COMBINATION_PRODUCT

Intrauterine balloon

intrauterine balloon applied intrauterine after hysteroscopic lysis of intrauterine adhesions

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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

Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes