Autologous Platelet-Rich Plasma in the Management of Asherman Syndrome

Phase 2

Completed

• Conditions: Intrauterine Adhesion
• Interventions: Device: Intrauterine balloon; Combination Product: amniotic membrane graft group; Biological: platelet rich plasma

• Registration Number: NCT04308811
• Lead Sponsor: 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

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 Timeline

• Study First Submitted: 2018-12-14
• Study Start: 2019-08-10
• Primary Completion: 2020-02-20
• Study Completion: 2020-02-20
• Status Verified: 2020-03
• Study First Submitted QC: 2020-03-12
• Last Update Submitted: 2020-03-12
• Study First Posted: 2020-03-16
• Last Update Posted: 2020-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

Severe intrauterine synechia confirmed by hysteroscopy

• age group from 20 to 40 years

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intrauterine balloon group	Intrauterine balloon	the clinician will perform hysteroscopic lysis of intrauterine adhesions followed by application of intrauterine balloon
amniotic membrane graft group	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.
platelet rich plasma group	platelet rich plasma	intrauterine platelet rich plasma injection and intrauterine balloon insertion after hysteroscopic lysis of intrauterine adhesions

Primary Outcome Measures

Name	Time	Method
Grade of intrauterine adhesions	after one month	Grade of intrauterine adhesions

Secondary Outcome Measures

Name	Time	Method
menstruation	within three months postoperative	amount of menstrual blood change

Trial Locations

Locations (1)

Endoscopy unit, Ain shams university Maternity hospital; 🇪🇬 Cairo, Egypt