Comparison of clinical outcomes of infertile men candidate for ICSI between two methods of sperm separation: Felix device based on surface electric charge and density gradient centrifugation (DGC)
Comparison of clinical outcomes of infertile couples’candidates for the ICSI using both sperm preparation methods: DGC and Felix.
Design
This clinical trial study with the control group, with parallel groups, one-arm blind, on 100 patients.
Settings and conduct
Isfahan Fertility and Infertility Center
Participants/Inclusion and exclusion criteria
Inclusion criteria: Infertile couples with male factor infertility (abnormal sperm parameters according to WHO 2021).
Exclusion Criteria: cryo-preserved semen samples, and sperm retrieved from testicular or epididymis
Intervention groups
For each couple, sperm will be processed by DGC and Felix methods.
Main outcome variables
Fertilization, Embryo quality, Blastocyst quality, Implantation, Chemical, and Clinical pregnancy, and live birth.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110804007223N11
Registration date:2022-06-09, 1401/03/19
Registration timing:registered_while_recruiting
Last update:2022-06-09, 1401/03/19
Update count:0
Registration date
2022-06-09, 1401/03/19
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
Expected recruitment start date
2022-06-01, 1401/03/11
Expected recruitment end date
2023-06-01, 1402/03/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of clinical outcomes of infertile men candidate for ICSI between two methods of sperm separation: Felix device based on surface electric charge and density gradient centrifugation (DGC)
Public title
Comparison of clinical outcomes between two sperm separation procedures: Felix vs. DGC
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Couples candidate for ICSI
The number of follicles: at least 10 MII oocytes.
Infertile couples with male factor infertility (sperm parameters lower than defined threshold by WHO 2021)
Female age ≤ 38 years
Men with at least 2ml semen
Embryo transfer only at blastocyst stage
One blastocyst for transfer
Normal female (female will be considered as normal if they have a regular cycle with patent tube and absence of endometriosis )
Men with a total sperm cell count higher than 5 million per ejaculate
Exclusion criteria:
Men with testicular sperm extraction or epididymal sperm aspiration
Men with cryo-preserved semen samples
Age
From 15 years old to 38 years old
Gender
Female
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
100
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The individual performing ICSI will be blinded to the methods of sperm processing (group one: density gradient centrifuge (DGC) method and group two: electric charge using a flex device method) and also the allocation of oocytes to each group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Royan Institute
Street address
Banihashem
City
Tehran
Province
Tehran
Postal code
8159358686
Approval date
2020-12-22, 1399/10/02
Ethics committee reference number
IR.ACECR.ROYAN.REC.1399.071
Health conditions studied
1
Description of health condition studied
Sperm selection procedure
ICD-10 code
N46
ICD-10 code description
Male infertility
Primary outcomes
1
Description
Blastocysts rate and quality
Timepoint
Day 5 or 6 after ICSI
Method of measurement
Microscope
Secondary outcomes
1
Description
Fertilization
Timepoint
16-18 hours after ICSI
Method of measurement
The number of 2PNs divided by the number of MII oocytes injected by ICSI multiplied by 100.
2
Description
Embryo quality
Timepoint
2 or 3 day after ICSI
Method of measurement
According to DK Gardner criteria (2016)
3
Description
biochemical pregnancy
Timepoint
Post implantation
Method of measurement
Beta hCG level
4
Description
Clinical pregnancy
Timepoint
Fifth or sixth week of pregnancy
Method of measurement
The observation of a fetal sacs and also fetal heartbeat by sonography.
5
Description
implantation
Timepoint
One to two weeks after blastocyst transfer
Method of measurement
Sonography
6
Description
Livebirth
Timepoint
At the time of delivery
Method of measurement
By phone call
Intervention groups
1
Description
For each semen sample, two procedures will be carried out for sperm preparation. One of the procedures (Control) will be used for half of the sibling oocytes, and another procedure (study) will be used for other sibling oocytes. Study (Flix) group: For each sample, one Felix cartridge will be used. 1ml of liquefied semen sample will be transferred to Felix SYSTEM. Each cartridge contains two chambers:1. Harvest chamber – 1ml of G-IVF Plus (Vitrolife; Sweden).2. Reservoir chambers (2) – 4mls of G-Rinse (Vitrolife; Sweden) in each (8mls total). The selected sperm will then be collected from the harvest chamber based on the electric charge, and the sperm wash medium (VitaSperm: Innovative Biotech, Iran) in addition to 10% human serum albumin will be added.
Category
Treatment - Devices
2
Description
Control (DGC) group: 1ml of 40% PureSperm gradient (Vitrolife; Sweden) will be transferred on 1ml of 80% PureSperm gradient (Vitrolife; Sweden) into a conical centrifuge tube. Then, 1ml of liquefied semen sample will be placed on the top of the upper layer, and the tube Will be centrifuged for 20 min at 1000rpm. The upper and lower layers will carefully be aspirated without disturbing the pellet. VitaSperm washing media (Innovative Biotech, Iran) + 10% human serum albumin will be then added to the pellet. Adjust sperm concentration DGC similar to sperm concentration Felix in the same volume.
Category
Treatment - Devices
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
Department of Reproductive Biotechnology, Reproductive Biomedicine Research Center, Royan Institute for Biotechnology, ACECR, Isfahan, Iran
City
Esfahan
Province
Isfehan
Postal code
8165131378
Phone
+98 31 3266 3016
Email
nasr.royan@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Royan Institute
Full name of responsible person
Parvaneh Afsharian
Street address
Royan Institute, Hafez St, Banihashem Ave, Resalat Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
8159358686
Phone
+98 21 2356 2000
Email
pafshar@royaninstitute.org
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
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
Royan Institute
Full name of responsible person
Mohammad Hossein Nasr-Esfahani
Position
Professor, An acadamic member of Royan Institute
Latest degree
Ph.D.
Other areas of specialty/work
Male infertility
Street address
Salman St; Royan St
City
Isfahan
Province
Isfehan
Postal code
8159358686
Phone
+98 31 9501 5682
Email
nasr.royan@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Royan Institute
Full name of responsible person
Mohammad Hossein Nasr-Esfahani
Position
Professor, An acadamic member of Royan Institute
Latest degree
Ph.D.
Other areas of specialty/work
Male infertility
Street address
Salman St; Royan St
City
Isfahan
Province
Isfehan
Postal code
8159358686
Phone
+98 31 9501 5682
Email
nasr.royan@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Royan Institute
Full name of responsible person
Marziyeh Tavalaee
Position
Associate Professor; An academic member of Royan Institute
Latest degree
Ph.D.
Other areas of specialty/work
Male infertility
Street address
Salman St; Royan St
City
Isfahan
Province
Isfehan
Postal code
8159358686
Phone
+98 31 9501 5682
Email
tavalaee.royan@gmail.com
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
Yes - There is 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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Consent form
Information regarding two sperm processing procure will be given to the couple. They will be informed that the best blastocyst will be selected for embryo transfer irrespective of the group, so that the fertility is not effected. The couples will be informed the Felix is very likely to be superior to DGC and very unlikely inferior.
The couple will be included in the study after formal presentation and signing the consent form.
When the data will become available and for how long
12 month after publication of the results
To whom data/document is available
Principle Investigator: Dr. Mohammad Hossein Nasr-Esfahani
Under which criteria data/document could be used
By permission of Memphasys company that provided Felix instrument and cartilages
From where data/document is obtainable
Principle Investigator: Dr. Mohammad Hossein Nasr-Esfahani
Royan Institute
What processes are involved for a request to access data/document
Via email of Dr. Mohammad Hossein Nasr-Esfahani
nasr.royan@gmail.com