Evaluation of the effect of GM-CSF cytokine on sperm parameters, PI3 kinase / AKT signaling pathway and glucose transporter in oligoastenoteratospermia and azoospermia men
Evaluation of the effect of GM-CSF cytokine on sperm parameters, PI3 kinase / AKT signaling pathway and glucose transporter in oligoastenoteratospermia and azoospermia men.
Design
Clinical trial with control group and parallel groups, and sample size of 40.
Settings and conduct
20 Obstructive azoospermia patients and 20 Oligoasthenoteratozoospermia patients who have male infertility factor, according to WHO criteria, are selected for sampling by referring to the Shahid Akbarabadi Hospital of Iran University of Medical Sciences. Each of the samples is divided into two groups; experiment, and control. In experimental group samples are incubated with 2 ng / ml GM-CSF for one hour, yet, in the control group, the sperms are incubated without GM-CSF for the same period of time. After oocyte collection, The eggs are divided into 2 groups. Half of the oocytes were inseminated with sperm that incubated with GM-CSF and remaining oocytes were inseminated with sperm from the control group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: infertile couples with male factor
Exclusion criteria: infertile couples with female factor
Intervention groups
Intervention group: Sperm incubation is performed in a medium containing GM-CSF for one hour.
Control group: Sperm incubation is performed in a GM-CSF-free medium for one hour.
Main outcome variables
Sperm parameters, DNA fragmentation index, mitochondrial membrane potential, expression of PI3k, AKT and GLUT genes, expression of AKT and GLUT proteins, fertilization rate, embryo quality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200519047508N1
Registration date:2020-05-30, 1399/03/10
Registration timing:prospective
Last update:2020-05-30, 1399/03/10
Update count:0
Registration date
2020-05-30, 1399/03/10
Registrant information
Name
Fatemeh Tanhaye Kalate Sabz
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 2030
Email address
tanhaykalateh.f@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2021-01-17, 1399/10/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of GM-CSF cytokine on sperm parameters, PI3 kinase / AKT signaling pathway and glucose transporter in oligoastenoteratospermia and azoospermia men
Public title
"The effect of GM-CSF cytokine on sperm"
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Men with semen parameters such as sperm count, motility and morphology, lower than WHO reference values
Men with Obstructive Azoospermia
Exclusion criteria:
Women over the age of 35, endometriosis, Polycystic ovary syndrome, Recurrent miscarriage
Age
No age limit
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, next to Milad Tower, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2020-04-05, 1399/01/17
Ethics committee reference number
IR.IUMS.FMD.REC.1399.085
Health conditions studied
1
Description of health condition studied
Male factor infertility, evaluation of the effect of GM-CSF
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Sperm motility
Timepoint
Assessments of sperm motility at the beginning of the study and after incubation in both intervention and control groups
Method of measurement
Optical microscope
2
Description
Mitochondrial membrane potential of sperm
Timepoint
Measurement of mitochondrial membrane potential after incubation in both intervention and control groups
Method of measurement
Jc- 1, Flow cytometry
3
Description
Sperm DNA fragmentation
Timepoint
Measurement of sperm DNA fragmentation after incubation in both intervention and control groups
Method of measurement
TUNEL method
4
Description
Fertilization Rate
Timepoint
24 hours after ICSI procedure
Method of measurement
View of 2 pronucleus with invert microscope
5
Description
Quality of embryo
Timepoint
Three days post-oocyte retrieval
Method of measurement
Using a three-point scoring system including fragmentation rate, number of blastomere, shape and size
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After washing, the sperms are incubated with medium containing 2 ng / ml GM-CSF for one hour, then they used for ICSI
Category
Treatment - Other
2
Description
Control group: After washing, the sperms are incubated with an environment without GM-CSF for one hour. After that, they used for ICSI.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Akbarabadi hospital
Full name of responsible person
Fatemesadat Amjadi
Street address
Bagh Ferdos Station; before Mowlavi cross section road; Mowlavi Ave
City
Tehran
Province
Tehran
Postal code
1168743514
Phone
+98 21 5560 6034
Email
akbarabadihosp@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyed Abas Motevalian
Street address
Iran University of Medical Sciences; Next to Milad Tower; Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
PR@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mahnaz Ashrafi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Iran University of Medical Sciences; Next to Milad Tower; Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
ashrafi.m@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mahnaz Ashrafi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Iran University of Medical Sciences; Next to Milad Tower; Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
ashrafi.m@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Fatemeh Tanhaye Kalate Sabz
Position
Ph.D student
Latest degree
Master
Other areas of specialty/work
Reproductive Biology
Street address
No. 2, South shayegh ., Amirkabir St., Aria Shahr
City
Tehran
Province
Tehran
Postal code
0000000000
Phone
+98 21 4426 4111
Email
fateme.1694@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
"There is no further information"
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available