Comparison of sperm function test from ejaculated sperm and short-ejaculated sperm
Design
selection of non-responder to antioxidant medical therapy with increased sperm DFI
Settings and conduct
selection of non-responder to antioxidant medical therapy with increased sperm DFI, in couple with recurrent pregnancy loss and recurrent assisted reproductive technique
Participants/Inclusion and exclusion criteria
Inclusion criteria: RPL, ART failure, male patient don't answer to treatment.
Exclusion criteria: varicocele, undescended tests, sexually transmitted disease, smoking, opium addiction, known hormonal abnormality
Intervention groups
sperm in short abstinence in non-responder to antioxidant medical therapy with increased sperm function test
Main outcome variables
short abstinence effect on sperm function test and semen parameter
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181214041968N1
Registration date:2018-12-26, 1397/10/05
Registration timing:registered_while_recruiting
Last update:2018-12-26, 1397/10/05
Update count:0
Registration date
2018-12-26, 1397/10/05
Registrant information
Name
Nima Narimani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2251 4239
Email address
n.narimani@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-22, 1397/10/01
Expected recruitment end date
2019-12-22, 1398/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of short Ejaculation on semen parameters and sperm function tests in non responder to medical trophy
Public title
The Effect of short Ejaculation on semen parameters and sperm function tests in non responder to medical trophy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
recurrent pregnancy loss
ART failure
Exclusion criteria:
Age
From 20 years old to 40 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
55
More than 1 sample in each individual
Number of samples in each individual:
2
All participants provide 2 semen samples during 24 hours and TUNEL and CMA3 will check on both samples.
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Yazd research and clinical center for infertility - shahid sadoughi university o
Street address
Boali Ave., Safayeh Ave.
City
Yazd
Province
Yazd
Postal code
8916877391
Approval date
2018-12-02, 1397/09/11
Ethics committee reference number
IR.SSU.RSI.REC.1397.021
Health conditions studied
1
Description of health condition studied
Recurrent abortion
ICD-10 code
ICD-10 code description
2
Description of health condition studied
ART failure
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
sperm function test
Timepoint
sperm function test in two consecutive days
Method of measurement
TUNEL test
2
Description
sperm function test
Timepoint
sperm function test in two consecutive days
Method of measurement
CMA3 Test
Secondary outcomes
empty
Intervention groups
1
Description
infertile male with increased sperm function test that have not respond to antioxidant medical therapy
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd research and clinical center for infertility
Full name of responsible person
Nima Narimani
Street address
Boali Ave., SafayehAve
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7086
Fax
+98 35 3824 7087
Email
n.narimani@ssu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
nima narimani
Street address
BoaliAve, Safayeh Ave.
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7086
Fax
+98 35 3824 7787
Email
n.narimani@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Yazd research and clinical center for infertility.
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
Yazd University of Medical Sciences
Full name of responsible person
nima narimani
Position
Researcher
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
BoaliAve, SafayehAve.
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7086
Fax
+98 35 3824 7087
Email
n.narimani@ssu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
nima narimani
Position
Researcher
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
BoaliAve, SafayehAve.
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7086
Fax
+98 35 3824 7087
Email
n.narimani@ssu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
nima narimani
Position
Researcher
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Boali Ave, Safayeh Ave.
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7086
Fax
+98 35 3824 7087
Email
n.narimani@ssu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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
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
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available