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Comparison of ICSI outcome in two sperm selection method: routine sperm selection and HOS method in infertile men

Protocol summary

Summary
In intra-cytoplasmic sperm injection (ICSI) technique selects sperm according to morphology and motility. Considering the role of sperm genomic quality as half of embryo genome, novel sperm selection procedures have been proposed to circumvent the possibility of inseminating DNA-damaged sperm. In routine sperm selection methods, sperm selected based on appearance properties such as motility and density. But sperm selection based on sperm functional properties may be efficient to recover normal sperm with normal DNA structure. It has been shown that different potential hypo-osmotic swelling test (HOST) patterns possess the potential to differentiate between sperm that have intact or damaged chromatin. Therefore this preliminary study evaluates the role of HOST as a sperm selection procedure in a clinical setting. In this study male factor infertile patient divided in control group that oocyte injected with selected sperm with Density Gradient Centrifuging method and" test" group oocyte injected with selected sperm with response to Hypo-Osmotic medium. Then result of fertilization rate, pregnancy and implantation rate compared between two groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201307087223N2
Registration date: 2013-10-27, 1392/08/05
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-10-27, 1392/08/05
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
Royan Iinstitute; Isfahan Fertility and Infertility Center
Expected recruitment start date
2012-08-22, 1391/06/01
Expected recruitment end date
2013-08-23, 1392/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of ICSI outcome in two sperm selection method: routine sperm selection and HOS method in infertile men
Public title
Comparison of Intra-cytoplasmic sperm injection outcomes during two sperm selection procedures: Density Gradient Centrifuging and response to Hypo Osmotic Swelling medium in male factor infertile patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: male factor infertility;oocyte number up to 8 Exclusion criteria: age>35, female factor infetility
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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
2013-08-14, 1392/05/23
Ethics committee reference number
1042/92/EC

Health conditions studied

1

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

Primary outcomes

1

Description
pregnancy rate
Timepoint
2 weeks after embryo transfer
Method of measurement
beta hCG test

Secondary outcomes

1

Description
fertilization rate
Timepoint
24 for after injectin sperm into oocyte during ICSI
Method of measurement
observation of two pronucleus under microscope

Intervention groups

1

Description
in control group: Endometer quality in the day of embryo transfer: if uterine endometer has a bad quality, good embryo freeze and low quality embryo may transferred that affect pregnancy outcome
Category
Other

2

Description
in test group: Endometer quality in the day of embryo transfer: if uterine endometer has a bad quality, good embryo freeze and low quality embryo may transferred that affect pregnancy outcome
Category
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 2123
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
Name of organization / entity
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 31 1951 5680
Fax
Email
mh_nasr@med.mui.ac.ir
Web page address

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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