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Comparison of efficiency of density gradient centrifuge (DGC) with combined DGC/Zeta method on ICSI outcome.

Protocol summary

Summary
The aim of this clinical controlled trial is evaluation and comparison of the ICSI outcome in male factor infertile patients, between the intervention group in which sperm is selected with Zeta method and the control group in which sperm is selected with routine density gradient centrifugation. In this study, 500 male factor infertile patients who meet the inclusion/exclusion criteria will be recruited and randomly assigned into intervention or control group. Fertilization rate, embryo quality and pregnancy rate are assessed and compared between the two groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201108047223N1
Registration date: 2011-12-27, 1390/10/06
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2011-12-27, 1390/10/06
Registrant information
Name
Mohammad Hossein Nasr-Esfahani
Name of organization / entity
Royan Institute (Royan Institute for Biotechnology)
Country
Iran (Islamic Republic of)
Phone
+98 31 9501 5688
Email address
mh_nasr@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Department of Reproduction and Development, Reproductive Biomedicine Research Center, Royan Institute for Animal Biotechnology, ACECR, Isfahan, Iran
Expected recruitment start date
2008-04-08, 1387/01/20
Expected recruitment end date
2012-04-08, 1391/01/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of efficiency of density gradient centrifuge (DGC) with combined DGC/Zeta method on ICSI outcome.
Public title
Effect of sperm selection based on surface charge on pregnancy outcome after ICSI
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: infertility with male factor such as oligozoospermia, asthenozoospermia, tratozoospermia Exclusion criteria: infertility with female factor criteria, female's age more than 40 years
Age
From 20 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 500
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics commitee of Royan institute
Street address
NO.2, Hafez street, Banihashem street, Resalat Ave, Tehran, Iran
City
Tehran
Postal code
Approval date
2011-10-15, 1390/07/23
Ethics committee reference number
پ/90/187

Health conditions studied

1

Description of health condition studied
Male factor infertility
ICD-10 code
N46
ICD-10 code description
Male infertility

Primary outcomes

1

Description
semen parameters
Timepoint
in day of ICSI procedure
Method of measurement
based on WHO 1999 criteria

2

Description
level of sperm DNA fragmentation
Timepoint
in day of ICSI procedure
Method of measurement
using TUNEL test

3

Description
fertilization rate
Timepoint
24 hours After ICSI procedure
Method of measurement
view of 2 pronucleus with invert microscope

4

Description
pregnancy
Timepoint
20 day after ICSI procedure
Method of measurement
beta HCG level in serum

Secondary outcomes

empty

Intervention groups

1

Description
sperm selection based on Zeta method for ICSI procedure
Category
Treatment - Other

2

Description
routine sperm selection method(density gradient centrifugation) for ICSI procedure in control group
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Isfahan fertility and infertility center
Full name of responsible person
Street address
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Royan institute
Full name of responsible person
Mohammad Hossein Nasr Esfahani
Street address
NO.2,Hafez street,Banihashem street,Resalat Ave,Tehran,Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Royan institute
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

2

Sponsor
Name of organization / entity
Isfahan fertility and infertility center
Full name of responsible person
Mohammad Hossein Nasr Esfahani
Street address
salman Farsi ave. Isfahan fertility and infertility center. isfahan
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan fertility and infertility center
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Royan Institute
Full name of responsible person
Mohammad Hossein Nasr Esfahani
Position
Ph.D
Other areas of specialty/work
Street address
NO.2, Hafez street, Banihashem street, Resalat Ave, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 2356 2000
Fax
Email
mh_nasr@med.mui.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Royan institute
Full name of responsible person
Mohammad Hossein Nasr Esfahani
Position
Ph.D
Other areas of specialty/work
Street address
NO.2,Hafez street,Banihashem street,Resalat Ave,Tehran,Iran
City
Tehran
Postal code
Phone
+98 21 2356 2000
Fax
Email
mh_nasr@med.mui.ac.ir
Web page address

Person responsible for updating data

Contact

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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