The Value of Using Platelet Rich Plasma After Hysteroscopic Lysis of Severe Intrauterine Adhesions
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2018
CompletedFirst Submitted
Initial submission to the registry
February 13, 2018
CompletedFirst Posted
Study publicly available on registry
May 31, 2018
CompletedMay 31, 2018
May 1, 2018
10 months
February 13, 2018
May 29, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Prevent recurrence of intrauterine adhesions
Prevent recurrence of intrauterine adhesions after hysteroscopic adhesiolysis assessed by office hysteroscopy according to American Fertility Society adhesion score: 1. Extent of cavity involved: ( \<1/3, 1/3 - 2/3, \>2/3 ) 2. Type of adhesions: (filmy, filmy to dense, dense) 3. menstrual pattern (normal, hypomenorrhea, amenorrhea)
Reassessed after one month
Secondary Outcomes (1)
Return of menses
Reassessed after one month
Study Arms (2)
Study Group
EXPERIMENTALPlatelet Rich Plasma
Control Group
ACTIVE COMPARATORIntrauterine Foley's Catheter
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ain Shams University Maternity Hospital
Cairo, 11357, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Mohamed I Amer, MD
Professor
- STUDY DIRECTOR
Mortada E Ahmed, MD
Lecturer
- STUDY DIRECTOR
Reda M Kamal, MD
Lecturer
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 13, 2018
First Posted
May 31, 2018
Study Start
April 1, 2017
Primary Completion
January 31, 2018
Study Completion
January 31, 2018
Last Updated
May 31, 2018
Record last verified: 2018-05