Back to resultsIntrauterine Autologous PRP Infusion Compared to HRT for Enhancing Endometrial Thickness in Patients Undergoing ICSI
Primary Purpose
Infertility
Status
Unknown status
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
platlet rich plasma
Sponsored by
About this trial
This is an interventional treatment trial for Infertility
Eligibility Criteria
Inclusion Criteria:
- patients undergoing ICSI
- endometrial thickness less than 7 mm on early follicular phase
Exclusion Criteria:
-
Sites / Locations
- RashaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Platlet rich plasma
Hormone replacement therapy
Arm Description
For those with endometrial thickness less than 7 mm intrauterine injection of platlet rich plasma (PRP) for enhancing endometrial thickness and receptivity
Oral intake of estradiol valerate for those with endometrial thickness less than 7 mm will improve endometrial receptivity
Outcomes
Primary Outcome Measures
endometrial thickness in mm
using transvaginal ultrasound to measure endometrial thickness in mm
Secondary Outcome Measures
clinical pregnancy rate
using transvaginal ultrasound to detect fetal cardiac activity
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02660294
Brief Title
Intrauterine Autologous PRP Infusion Compared to HRT for Enhancing Endometrial Thickness in Patients Undergoing ICSI
Official Title
Intrauterine Autologous Platelet -Enriched Plasma Infusion Compared to Hormonal Replacement Therapy for Enhancing Endometrial Thickness in Patients Undergoing ICSI
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
March 2016 (undefined)
Primary Completion Date
March 2017 (Anticipated)
Study Completion Date
April 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Successful embryo implantation needs an optimum embryonic development with a receptive endometrium. Endometrial thickness is an independant factor for endometrial receiptivity. The aim of that trial is to assess the benefecial effect of platelt rich plasma in copmarison with standard hormonal therapy.
Detailed Description
This is a single blinded randomized trial comparing the effect of of platlet rich plasma versus hormonal therapy on endometrial thickness and consequently endometrial receptivity. The primary endpoint of this trial is clinical pregnancy rate.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Platlet rich plasma
Arm Type
Experimental
Arm Description
For those with endometrial thickness less than 7 mm intrauterine injection of platlet rich plasma (PRP) for enhancing endometrial thickness and receptivity
Arm Title
Hormone replacement therapy
Arm Type
No Intervention
Arm Description
Oral intake of estradiol valerate for those with endometrial thickness less than 7 mm will improve endometrial receptivity
Intervention Type
Biological
Intervention Name(s)
platlet rich plasma
Intervention Description
Platelet-rich plasma (PRP) is prepared from fresh whole blood which is collected from a peripheral vein, stored in acid citrate dextrose solution A (ACD-A) anticoagulant and processed to increase platelets by separating various components of blood
Primary Outcome Measure Information:
Title
endometrial thickness in mm
Description
using transvaginal ultrasound to measure endometrial thickness in mm
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
clinical pregnancy rate
Description
using transvaginal ultrasound to detect fetal cardiac activity
Time Frame
4 weeks after embryo transfer
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
patients undergoing ICSI
endometrial thickness less than 7 mm on early follicular phase
Exclusion Criteria:
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
rasha Dr medhat, MD
Phone
1224448449
Ext
0020
Email
RASHAMEDHAT30@GMAIL.COM
First Name & Middle Initial & Last Name or Official Title & Degree
ahmed DR kotb, MD
Phone
1008681999
Ext
0020
Email
ahmedmkotp@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
RASHA DR MEDHAT, MD
Organizational Affiliation
Ain Shams University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rasha
City
Cairo
State/Province
Al Qahirah
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rasha M Abdul-hady, MD
Phone
1224448449
Ext
0020
Email
rashamedhat30@gmail.com
First Name & Middle Initial & Last Name & Degree
ahmed M kotb, MD
Phone
1004711414
Ext
0020
Email
ahmedmkotp@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Intrauterine Autologous PRP Infusion Compared to HRT for Enhancing Endometrial Thickness in Patients Undergoing ICSI
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