Autologous Platelet-Rich Plasma in the Management of Asherman Syndrome

Ain Shams University

Status and phase: Completed; Phase 2

Conditions: Intrauterine Adhesion

Treatments: Device: Intrauterine balloon; Biological: platelet rich plasma; Combination Product: amniotic membrane graft group

Study type: Interventional

Funder types: Other

Identifiers

NCT04308811

ASU456

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

platelet rich plasma group

Other group

Description:

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

Treatment:

Biological: platelet rich plasma

amniotic membrane graft group

Other group

Description:

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

Treatment:

Combination Product: amniotic membrane graft group

intrauterine balloon group

Other group

Description:

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

Treatment:

Device: Intrauterine balloon