Utilizing the Platelet Rich Plasma (PRP) method to improve sperm function and increase chances of fertility in Intrauterine Insemination (IUI) in patients
Confirmmation the method of using PRP in improving sperm parameters and increasing fertility chances in IUI patients
Design
A clinical trial with a control group, with factorial groups, not blinded, was used on 200 patients to improve sperm function and fertility.
Settings and conduct
According to the studies conducted in this field on male infertile patients and IVF, for the first time a clinical trial on IUI patients will be conducted in the andrology department of Noble Laboratory of Isfahan.
Participants/Inclusion and exclusion criteria
Limitless
Intervention groups
The study has two intervention groups including: treatment group with (IUI) intrauterine insemination method and treatment group with intrauterine insemination+Platelet-rich plasma (IUI+PRP) method.
Main outcome variables
The effect of growth factors and platelets in (PRP) Platelet-rich plasma on reducing the amount of (ROS) Reactive oxygen species, increasing effective sperm motility and reducing sperm DNA Fragmentation in improving fertility and (IUI) intrauterine insemination results
General information
Reason for update
Acronym
PISFI
IRCT registration information
IRCT registration number:IRCT20230314057714N1
Registration date:2023-03-26, 1402/01/06
Registration timing:prospective
Last update:2023-03-26, 1402/01/06
Update count:0
Registration date
2023-03-26, 1402/01/06
Registrant information
Name
soraya savoj
Name of organization / entity
Nobel medical laboratory
Country
Iran (Islamic Republic of)
Phone
+98 31 3627 9670
Email address
svjalex@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-21, 1402/02/01
Expected recruitment end date
2023-08-23, 1402/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Utilizing the Platelet Rich Plasma (PRP) method to improve sperm function and increase chances of fertility in Intrauterine Insemination (IUI) in patients
Public title
Investigating the effect of PRP on increasing fertility in IUI patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
unlimited
Exclusion criteria:
Age
No age limit
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
-Nobel Laboratory
Street address
-Hakim Nizami Street, Shahid Falahpour Alley, No. 1, Nobel Laboratory
City
-Isfahan
Province
Isfehan
Postal code
1111111111
Approval date
2024-03-18, 1402/12/28
Ethics committee reference number
-rec003
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N46
ICD-10 code description
Male infertility
Primary outcomes
1
Description
Fertility increase percentage
Timepoint
Sampling day
Method of measurement
Visual Analogue Scale
2
Description
Percentage of Sperm Motility
Timepoint
Sampling day
Method of measurement
Optical Microscope
Secondary outcomes
empty
Intervention groups
1
Description
Control group: 1 ml IUI Sample without 1 Ml PRP
Category
Treatment - Other
2
Description
Intervention group: 1 ml IUI Sample with 1 Ml PRP
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Nobel Medical Laboratory
Full name of responsible person
Dr Mohammad Reza Deemeh
Street address
Hakim Nizami Street, Shahid Falahpour Alley, No. 1, Nobel Laboratory
City
Isfahan
Province
Isfehan
Postal code
1111111111
Phone
+98 31 3627 9670
Email
info@nobellab.ir
Web page address
http://www.nobellab.com/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Nobel Laboratory
Full name of responsible person
Dr Ali Ajami
Street address
Hakim Nizami Street, Shahid Falahpour Alley, No. 1, Nobel Laboratory
City
Isfahan
Province
Isfehan
Postal code
1111111111
Phone
+98 31 3627 9670
Email
info@nobellab.ir
Web page address
http://www.nobellab.com/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Nobel Laboratory
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Nobel Laboratory
Full name of responsible person
soraya savoj
Position
Andrologist
Latest degree
Master
Other areas of specialty/work
Reproductive Health
Street address
Hakim Nizami Street, Shahid Falahpour Alley, No. 1, Nobel Laboratory
City
Isfahan
Province
Isfehan
Postal code
1111111111
Phone
00980336279670
Email
Svjalex@gmail.com
Web page address
http://www.nobellab.com/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Nobel Laboratory
Full name of responsible person
Hamid Rezaei Soreshjani
Position
Andrologist
Latest degree
Bachelor
Other areas of specialty/work
Reproductive Health
Street address
Hakim Nizami Street, Shahid Falahpour Alley, No. 1, Nobel Laboratory
City
Isfahan
Province
Isfehan
Postal code
1111111111
Phone
00980332679670
Email
sorayya.1994@gmail.com
Web page address
http://www.nobellab.com/
Person responsible for updating data
Contact
Name of organization / entity
Nobel Laboratory
Full name of responsible person
Soraya Savoj
Position
Andrologist
Latest degree
Master
Other areas of specialty/work
Reproductive Health
Street address
Hakim Nizami Street, Shahid Falahpour Alley, No. 1, Nobel Laboratory
City
Isfahan
Province
Isfehan
Postal code
1111111111
Phone
+98 31 3267 9670
Email
svjalex@gmail.com
Web page address
http://www.nobellab.com/
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Part of the data, such as information about the main outcome
When the data will become available and for how long
The access period starts 12 months after the results are published
To whom data/document is available
Doctors and researchers working in academic and scientific institutions
Under which criteria data/document could be used
In order to carry out studies and clinical treatments in the field of fertility, male infertility and IUI
From where data/document is obtainable
http://www.nobellab.com
infpo@nobellab.com
009803132679670
Department of Andrology
What processes are involved for a request to access data/document
Coordination with Nobel Laboratory, Andrology Department