Comparison of clinical outcomes between Natural Sperm Sorting (NSS) and Direct Swim Up (DSU) in ICSI program; Assessments of mitocondorial, chromatin integrity and fine morphology (MSOME)
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General information
3
2
32
2021-10-21, 1400/07/29
2021-12-22, 1400/10/01
2021-1012-2122 00:00:00
2021-11-30, 1400/09/09
2022-01-30, 1400/11/10
20212022-1101-30 00:00:00
Sampling earlier than expected is the end date
Update sampling date
Sampling earlier than expected is the endUpdate sampling date
نمونه گيري زودترازتاريخ موردانتظارثبت شده پايان يافته است.
به روزسانی تاریخ نمونه گیری
به روزسانی تاریخ نمونه گيري زودترازتاريخ موردانتظارثبت شده پايان يافته است.گیری
Each sample is divided into two parts for DSU separation and the other for NSS separation.
Each mixed semen sample was split into two equal portions, with the first being processed using the DSU technique (control) and the second using the FCS method (experimental)
Each mixed semen sample is dividedwas split into two parts forequal portions, with the first being processed using the DSU separationtechnique (control) and the other for NSS separation.second using the FCS method (experimental)
نمونه سیمن هرفرددوقسمت میشودیکی برای جداسازی به روش DSUودیگری برای جداسازی به روش NSS
هر نمونه سیمن به دو قسمت مساوی تقسیم که اولی با استفاده از تکنیک DSU (شاهد) و دومی با استفاده از روش FCS (تجربی) پردازش میشود.
هر نمونه سیمن هرفرددوقسمت میشودیکی برای جداسازی به دو قسمت مساوی تقسیم که اولی با استفاده از تکنیک DSU (شاهد) و دومی با استفاده از روش DSUودیگری برای جداسازی به روش NSSFCS (تجربی) پردازش میشود.
Protocol summary
Study aim
Comparison of clinical outcomes between Natural Sperm Sorting and Direct Swim Up in ICSI program in the donation casee
Design
Clinical trial was performed with parallel control and intervention groups, study on 50 infertile couples who donated oocyte
Settings and conduct
Among the patients who refer to Yazd Infertility Center, 50 samples of normal semen are randomly selected. Female infertility and candidate egg donation were the main diagnostic factors for all couples, and all patients received written consent to participate in the study protocol.
Participants/Inclusion and exclusion criteria
The inclusion criteria : the female feature patient that needs oocyte donation and normal sperm and donor female feature as follows: donor age<30 with having at least 5 metaphase II oocyte
The exclusion criteria : surgical sperm retrieval; female donor age>30, frozen donor eggs; cancelled cycles and cycles with missing key data
Intervention groups
Each person's sperm sample is divided into two parts:
Interventional group: they are prepared in a method without using a centrifuge.
Control group: No intervention is made.
Main outcome variables
Chemical pregnancy rate and clinical pregnancy rate
General information
Reason for update
Update sampling date
Acronym
IRCT registration information
IRCT registration number:IRCT20201104049263N1
Registration date:2021-09-13, 1400/06/22
Registration timing:prospective
Last update:2022-03-04, 1400/12/13
Update count:2
Registration date
2021-09-13, 1400/06/22
Registrant information
Name
Fateme Dehghanpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3626 6855
Email address
dehghanpour64@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-16, 1400/06/25
Expected recruitment end date
2022-03-11, 1400/12/20
Actual recruitment start date
2021-09-16, 1400/06/25
Actual recruitment end date
2021-12-22, 1400/10/01
Trial completion date
2022-01-30, 1400/11/10
Scientific title
Comparison of clinical outcomes between Natural Sperm Sorting (NSS) and Direct Swim Up (DSU) in ICSI program; Assessments of mitocondorial, chromatin integrity and fine morphology (MSOME)
Public title
Evaluation of the effect of sperm preparation by free centrifugation on clinical outcomes in ICSI cycles
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Non male factor
Female with donation cases for homogenization Study groups
Exclusion criteria:
Male factor
Female factor
Age
From 20 years old to 40 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
50
More than 1 sample in each individual
Number of samples in each individual:
2
Each sample is divided into two parts for DSU separation and the other for NSS separation.
Actual sample size reached:
60
More than 1 sample in each individual
Actual sample size in each individual:
2
Each mixed semen sample was split into two equal portions, with the first being processed using the DSU technique (control) and the second using the FCS method (experimental)
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Yazd University of Medical Sciences
Street address
Research Institute of Reproductive Sciences, Bouali St., Safaieh
City
Yazd
Province
Yazd
Postal code
8916877391
Approval date
2021-01-06, 1399/10/17
Ethics committee reference number
IR.SSU.MEDICINE.REC.1399.259
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
Fertilization rate
Timepoint
One day after assisted artificial insemination
Method of measurement
Microscopic examination
2
Description
Embryo formation rate
Timepoint
3 days after assisting artificial insemination
Method of measurement
Microscopic evaluation
3
Description
Chemical pregnancy rate
Timepoint
One week after the embryo transfer to the uterus
Method of measurement
Blood βHCG Measurement
Secondary outcomes
1
Description
Clinical pregnancy rate
Timepoint
7 weeks after embryo transfer to the uterus
Method of measurement
Assessment of cardiovascular formation using ultrasound examination
Intervention groups
1
Description
Control group: sorted sperm with Direct swim up.
Category
Treatment - Other
2
Description
Intervention group: Sperms that are isolated by NSS method.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Infertility Research Center- Shahid Sadoughi University of Medical Sciences, Yazd
Full name of responsible person
Abbas Aflatoonian
Street address
Bouali Street, Safaieh, Yazd
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 8119
Email
dehghanpou64@yahoo.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Masoud Mirzaei
Street address
Bouali Street, Safaieh
City
YAzd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 8119
Email
dehghanpour64@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd University of Medical Sciences
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
Mohammad Ali Khalili
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Biology
Street address
Bouali street, Safaieh
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 8119
Email
khalili59@hotmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Mohammad Ali Khalili
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Biology
Street address
Bouali street, Safaieh
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Email
khalili59@hotmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Fatemeh Dehghanpour
Position
PhD candidate in Reprod. Biol.
Latest degree
Master
Other areas of specialty/work
Reproductive Biology
Street address
Bouali street, Safaieh
City
Yazd
Province
Yazd
Postal code
8913965751
Phone
+98 35 3626 6855
Email
dehghanpour64@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Yes - There is a plan to make this available
Title and more details about the data/document
Data: 1) Fertility rate, by examining the formation of proonucleus in the egg cell
2) Checking the embryo quality and calculating the time related to the process of cell division of the embryo
3) Checking the chemical and clinical pregnancy rates respectively one week and 7 weeks after embryo transfer
When the data will become available and for how long
Up to one year after publication of the article
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
With the re-consent of the participant and the researcher responsible of the projec
From where data/document is obtainable
Mohammad Ali Khalili 09133570876
khalili59@hotmail.com
What processes are involved for a request to access data/document
mohammad ali khalili 09133570876 khalili59@hotmail.com