Autologous Platelet-Rich Plasma in the Management of Ashe... | NCT04308811

Studies
Autologous Platelet-Rich Plasma in the Management of Asherman Syndrome

NCT04308811

Sponsor

Ain Shams University

Status

Completed

Last Update Posted

Mar 16, 2020Actual

Enrollment

60Actual

Phase

Phase 2

Conditions

Intrauterine Adhesion

Interventions

platelet rich plasma
amniotic membrane graft group
Intrauterine balloon

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 10, 2019Actual

Primary Completion Date

Feb 20, 2020Actual

Completion Date

Feb 20, 2020Actual

First Submitted Date

Dec 14, 2018

First Submission Date that Met QC Criteria

Mar 12, 2020

First Posted Date

Mar 16, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 12, 2020

Last Update Posted Date

Mar 16, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mohamed I Amer, Professor, Ain Shams UniversityPrincipal Investigator

Lead Sponsor

Ain Shams UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
platelet rich plasma group	Other	intrauterine platelet rich plasma injection and intrauterine balloon insertion after hysteroscopic lysis of intrauterine adhesions	Biological: platelet rich plasma
amniotic membrane graft group	Other	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
intrauterine balloon group	Other	the clinician will perform hysteroscopic lysis of intrauterine adhesions followed by application of intrauterine balloon	Device: Intrauterine balloon

Interventions

Name	Type	Description	Arm Group Labels	Other Names
platelet rich plasma	Biological	Platelet rich plasma and intrauterine balloon applied intrauterine after hysteroscopic adhesiolysis of intrauterine adhesions	platelet rich plasma group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Endoscopy unit, Ain shams university Maternity hospital		Cairo			Egypt

Condition Browse Module

MeSH Terms

ID	Term
D006175	Gynatresia

Ancestor Terms

ID	Term
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

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.