Comparison of clinical outcomes in two sperm selection procedures (density gradient centrifugation with surface markers- density gradient centrifugation) in infertile men intra-cytoplasmic sperm injection candidate
Objectives: Comparison of clinical outcomes in routine (density gradient centrifugation: DGC) with novel sperm selection procedures (surface markers-density gradient centrifugation: MACS-DGC) in infertile men ICSI candidate.
Design: Infertile couples with primary male factor infertility were included in this study and referred to Isfahan fertility and infertility center. These individuals were informed about the study and were grouped .
Setting and conduct: In the day of ICSI operation, after choosing 50 infertile couples, sibling oocytes divided into two groups: half of the oocytes were inseminated with sperm that selected with MACS-DGC processing (MACS-DGC group) and remaining oocytes were inseminated with sperm that selected with DGC method (based on viability and morphology) ( internal control or DGC group). In the external control group all the oocytes were inseminated by sperm that selected with DGC method (based on viability and morphology).
Major Inclusion and Exclusion criteria: Inclusion criteria: Primary male factor infertility (according to the WHO-2010); Exclusion criteria: females factor infertility with higher than 35 years and less than 6. oocytes Intervention: In study group, half of oocytes were inseminated with sperm that selected with DGC following MACS processing (Separate intact spermatozoa from those that present apoptotic markers) (MACS-DGC group).
Main outcome measures (variables): In this study, for first time the clinical outcomes such as fertilization, embryo quality and pregnancy rates in these groups will be compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201504307223N3
Registration date:2015-10-11, 1394/07/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-10-11, 1394/07/19
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 Institute
Expected recruitment start date
2014-01-28, 1392/11/08
Expected recruitment end date
2015-07-30, 1394/05/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of clinical outcomes in two sperm selection procedures (density gradient centrifugation with surface markers- density gradient centrifugation) in infertile men intra-cytoplasmic sperm injection candidate
Public title
Comparison of clinical outcomes in tow sperm selection procedure
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: Primary male factor infertility (at least, two of their semen parameters were considered as abnormal according to the WHO-2010)
Exclusion criteria: Females factor infertility basely WHO criteria (2010) with higher than 35 years and less than 6 oocytes
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:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Commitee of Royan Institue
Street address
Hafez St, Banihashem St, Resalat Ave, Tehran, Iran, Royan Institute
City
Tehran
Postal code
Approval date
2014-08-02, 1393/05/11
Ethics committee reference number
EC/93/1101
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
Sperm motility
Timepoint
In daye of ICSI procedure
Method of measurement
Using optical microscope, based WHO criteria
2
Description
Sperm concentration
Timepoint
In daye of ICSI procedure
Method of measurement
Using optical microscope, based WHO criteria
3
Description
Sperm morphology
Timepoint
In daye of ICSI procedure
Method of measurement
Using optical microscope, based WHO criteria
4
Description
Fertilization rate
Timepoint
24 hours after ICSI procedure
Method of measurement
View of 2 pronucleuse with invert microscp
5
Description
Chemical pregnancy
Timepoint
18 days after ICSI procedure
Method of measurement
Measurement of Beta HCG level in serum
6
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
7
Description
Clinical l pregnancy
Timepoint
12 weeks after ICSI procedure
Method of measurement
Fetal heart beat
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Half of oocytes were inseminated with sperm that selected with DGC following MACS processing (Separate intact spermatozoa from those that present apoptotic markers by magnetic particles conjugated with Annexin V, which has a high affinity for Phosphatidylserine)(MACS-DGC group).
Category
Other
2
Description
Internal control group: Remaining oocytes were inseminated with sperm that selected with DGC method (based on viability and morphology) (DGC group)
Category
Other
3
Description
External control group: َAll the oocytes were inseminated by sperm that selected with DGC method
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan Fertility and Infertility Center
Full name of responsible person
Mohammad Hossein Nasr Esfahani
Street address
Salman Farsi St, Isfahan, Iran, Fertility and Infertility Center
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Royan Institute
Full name of responsible person
Abdolhossein Shahverdi
Street address
Royan St, Salman St, KHorasgan, Isfahan, Iran, Royan Institute for Biotechnology
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
100
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 (Royan Institute for Biotechnology)
Full name of responsible person
Mohammad Hossein Nasr-Esfahani
Position
Professor
Other areas of specialty/work
Street address
Royan St, Salman St, KHorasgan, Isfahan, Iran, Royan Institute for Biotechnology
City
Isfahan
Postal code
Phone
+98 31 9501 5688
Fax
+98 31 9501 5687
Email
mh_nasr@med.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Royan Institute (Royan Institute for Biotechnology)
Full name of responsible person
Mohammad Hossein Nasr-Esfahani
Position
Professor
Other areas of specialty/work
Street address
Royan St, Salman St, KHorasgan, Isfahan, Iran, Royan Institute for Biotechnology
City
Isfahan
Postal code
Phone
+98 31 9501 5688
Fax
+98 31 9501 5687
Email
mh_nasr@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Royan Institute (Royan Institute for Biotechnology)
Full name of responsible person
Mohammad Hossein Nasr-Esfahani
Position
Professor
Other areas of specialty/work
Street address
Royan St, Salman St, KHorasgan, Isfahan, Iran, Royan Institute for Biotechnology
City
Isfahan
Postal code
Phone
+98 31 9501 5688
Fax
Email
mh_nasr@med.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)