Back to resultsPRP in Intracytoplasmic Sperm Injection
Primary Purpose
Infertility
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Platelet rich plasma
Sponsored by
About this trial
This is an interventional other trial for Infertility
Eligibility Criteria
Inclusion Criteria:
- women with primary infertility
Exclusion Criteria:
- women with unexplained infertility
Sites / Locations
- Algazeerah
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
PRP
No PRP
Arm Description
women who will receive PRP before ICSI
women who willnot receive PRP before ICSI
Outcomes
Primary Outcome Measures
The number of women wo will have chemical pregnancy
how many women will have chemical pregnancy
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04354363
Brief Title
PRP in Intracytoplasmic Sperm Injection
Official Title
Role of PRP in Intracytoplasmic Sperm Injection in Infertile Women
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 22, 2020 (Anticipated)
Primary Completion Date
February 15, 2021 (Anticipated)
Study Completion Date
March 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aljazeera Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Infertility is a major problem nowadays
Detailed Description
ovarian and uterine factor of infertility are very hard to treat
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
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A randomized controlled trial
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PRP
Arm Type
Active Comparator
Arm Description
women who will receive PRP before ICSI
Arm Title
No PRP
Arm Type
No Intervention
Arm Description
women who willnot receive PRP before ICSI
Intervention Type
Other
Intervention Name(s)
Platelet rich plasma
Intervention Description
Giving women PRP before ICSI
Primary Outcome Measure Information:
Title
The number of women wo will have chemical pregnancy
Description
how many women will have chemical pregnancy
Time Frame
within 3 months
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
women with infertility
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
women with primary infertility
Exclusion Criteria:
women with unexplained infertility
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mahmoud Alalfy, PhD
Phone
01002611058
Email
mahmoudalalfy@ymail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahmoud Alalfy, PhD
Organizational Affiliation
Algezeera hospitaland National Research Centre ,Egypt
Official's Role
Study Chair
Facility Information:
Facility Name
Algazeerah
City
Giza
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mahmoud Alalfy, master
Phone
+201002611058
Email
mahmoudalalfy@ymail.com
First Name & Middle Initial & Last Name & Degree
Ahmed Elgazzar, M.D
Phone
+201014005959
First Name & Middle Initial & Last Name & Degree
Mahmoud Alalfy, master
12. IPD Sharing Statement
Learn more about this trial
PRP in Intracytoplasmic Sperm Injection
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