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The Value of Using Platelet Rich Plasma After Hysteroscopic Lysis of Severe Intrauterine Adhesions

Primary Purpose

Intrauterine Adhesion

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Platelet Rich Plasma
Intrauterine Foley's Catheter
Sponsored by
Ain Shams Maternity Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Intrauterine Adhesion

Eligibility Criteria

18 Years - 43 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Infertility due to Asherman's syndrome with history of hypomenorrhea or amenorrhea and infertility and evaluated by office hysteroscopy to confirm the presence of sever adhesions according to American fertility society.

Exclusion Criteria:

  • Hb < 11 g/dL, platelets < 150.000/mm3
  • Patient taking anticoagulant.
  • Patient taking NSAID in the 10 days before procedure.
  • Any significant comorbidity or psychiatric disorder that would compromise patient's consent.
  • Active cervical or uterine infection.

Sites / Locations

  • Ain Shams University Maternity Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Study Group

Control Group

Arm Description

Platelet Rich Plasma

Intrauterine Foley's Catheter

Outcomes

Primary Outcome Measures

Prevent recurrence of intrauterine adhesions
Prevent recurrence of intrauterine adhesions after hysteroscopic adhesiolysis assessed by office hysteroscopy according to American Fertility Society adhesion score: Extent of cavity involved: ( <1/3, 1/3 - 2/3, >2/3 ) Type of adhesions: (filmy, filmy to dense, dense) menstrual pattern (normal, hypomenorrhea, amenorrhea)

Secondary Outcome Measures

Return of menses
Return/normalization of expected menses by history (yes/no)

Full Information

First Posted
February 13, 2018
Last Updated
May 29, 2018
Sponsor
Ain Shams Maternity Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03541746
Brief Title
The Value of Using Platelet Rich Plasma After Hysteroscopic Lysis of Severe Intrauterine Adhesions
Official Title
The Value of Using Platelet Rich Plasma After Hysteroscopic Lysis of Severe Intrauterine Adhesions (A Randomized Controlled Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
January 31, 2018 (Actual)
Study Completion Date
January 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams Maternity Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of present study is to evaluate the effect of the use of platelet rich plasma in decreasing recurrence of intrauterine adhesions after its lysis.
Detailed Description
Research question: In women undergoing hysteroscopic adhesiolysis, does postoperative use of platelet rich plasma decrease the recurrence of intrauterine adhesions? Research hypothesis: In women undergoing hysteroscopic adhesiolysis for Asherman's syndrome, postoperative use of platelet rich plasma may decrease the recurrence of intrauterine adhesions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intrauterine Adhesion

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study Group
Arm Type
Experimental
Arm Description
Platelet Rich Plasma
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Intrauterine Foley's Catheter
Intervention Type
Biological
Intervention Name(s)
Platelet Rich Plasma
Intervention Description
After hysteroscopic adhesiolysis, 30 patients will undergo once injection of 5ml PRP into the wall then lining the uterine cavity by 5ml platelet rich plasma gel. Finally, Foley balloon catheter will be inserted intrauterine then inflated and cutting its stem and to be left for two weeks.
Intervention Type
Device
Intervention Name(s)
Intrauterine Foley's Catheter
Intervention Description
After hysteroscopic adhesiolysis, 30 patients will undergo intrauterine insertion of one inflated Foley balloon catheter with cutting its stem only to be left for two weeks.
Primary Outcome Measure Information:
Title
Prevent recurrence of intrauterine adhesions
Description
Prevent recurrence of intrauterine adhesions after hysteroscopic adhesiolysis assessed by office hysteroscopy according to American Fertility Society adhesion score: Extent of cavity involved: ( <1/3, 1/3 - 2/3, >2/3 ) Type of adhesions: (filmy, filmy to dense, dense) menstrual pattern (normal, hypomenorrhea, amenorrhea)
Time Frame
Reassessed after one month
Secondary Outcome Measure Information:
Title
Return of menses
Description
Return/normalization of expected menses by history (yes/no)
Time Frame
Reassessed after one month

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
43 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Infertility due to Asherman's syndrome with history of hypomenorrhea or amenorrhea and infertility and evaluated by office hysteroscopy to confirm the presence of sever adhesions according to American fertility society. Exclusion Criteria: Hb < 11 g/dL, platelets < 150.000/mm3 Patient taking anticoagulant. Patient taking NSAID in the 10 days before procedure. Any significant comorbidity or psychiatric disorder that would compromise patient's consent. Active cervical or uterine infection.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed I Amer, MD
Organizational Affiliation
Professor
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mortada E Ahmed, MD
Organizational Affiliation
Lecturer
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Reda M Kamal, MD
Organizational Affiliation
Lecturer
Official's Role
Study Director
Facility Information:
Facility Name
Ain Shams University Maternity Hospital
City
Cairo
ZIP/Postal Code
11357
Country
Egypt

12. IPD Sharing Statement

Learn more about this trial

The Value of Using Platelet Rich Plasma After Hysteroscopic Lysis of Severe Intrauterine Adhesions

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