Autologous Platelet-Rich Plasma in the Management of Asherman Syndrome

• ClinicalTrials.gov Identifier: NCT04308811
• Recruitment Status: Completed
• First Posted: March 16, 2020
• Last Update Posted: March 16, 2020
• Sponsor: Ain Shams University
• Information provided by (Responsible Party): Mohamed I Amer, Ain Shams University

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

Condition or disease	Intervention/treatment	Phase
Intrauterine Adhesion	Biological: platelet rich plasma; Combination Product: amniotic membrane graft group; Device: Intrauterine balloon	Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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)
• Primary Purpose: Treatment
• Official Title: Platelet-Rich Plasma in the Management of Asherman Syndrome
• Actual Study Start Date: August 10, 2019
• Actual Primary Completion Date: February 20, 2020
• Actual Study Completion Date: February 20, 2020

Arms and Interventions

Arm	Intervention/treatment
platelet rich plasma group; intrauterine platelet rich plasma injection and intrauterine balloon insertion after hysteroscopic lysis of intrauterine adhesions	Biological: platelet rich plasma; 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.	Combination Product: amniotic membrane graft group; 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	Device: Intrauterine balloon; intrauterine balloon applied intrauterine after hysteroscopic lysis of intrauterine adhesions

Outcome Measures

Primary Outcome Measures :

1. Grade of intrauterine adhesions [ Time Frame: after one month ]
   Grade of intrauterine adhesions

Secondary Outcome Measures :

1. menstruation [ Time Frame: within three months postoperative ]
   amount of menstrual blood change

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 40 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

Egypt

Endoscopy unit, Ain shams university Maternity hospital

Cairo, Egypt

Sponsors and Collaborators

Ain Shams University

More Information

• Responsible Party: Mohamed I Amer, Professor, Ain Shams University
• ClinicalTrials.gov Identifier: NCT04308811
• Other Study ID Numbers: ASU456
• First Posted: March 16, 2020
• Last Update Posted: March 16, 2020
• Last Verified: March 2020

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

Additional relevant MeSH terms:

Gynatresia