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Comparison of the effects of sperm selection using sperm bounded to zona pellusida of immature oocyte and sperm selection by current methods on embryo morphokinitic and clinical fertility outcomes in infertile couples

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History
# Registration date Revision Id
2 2022-04-10, 1401/01/21 223096
1 2020-09-01, 1399/06/11 149222
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  • General information

    50
    70
    Yes
    No
    1
    empty
    empty
    50
    No
    No
    empty
    2020-10-28, 1399/08/07
    empty
    2022-01-05, 1400/10/15
    empty
    2022-04-23, 1401/02/03
    empty
    1- The reason for changing the start time of the study was that we had to start work after the production of IRCT approval. 2- Remove of one of the secondary outcome named integration of embryo zona pellucida was that the embryos would not be out of the incubator for longer than necessary. 3- Primary and secondary outcomes updated. 4-The target sample size was updated (after statistical study, the decision was made to change).
    empty
    1- دلیل تغییر زمان واقعی شروع مطالعه این بود که بعد از صدور تاییدیه IRCT کار را شروع کردیم. 2- حذف یکی از پیامد هایی ثانویه به نام میزان انسجام زونا پلوسیدا در جنین برای این منظور بود که جنین ها بیشتر از زمان ضروری بیرون از انکوباتور نمانند 3- پیامدهای اولیه و ثانویه به روزرسانی شد. 4-اندازه جامعه هدف به روز رسانی شد( بعد از مطالعه آماری تصمیم به تغییر گرفته شد).
    Non ejaculated spermatozoa (testicular or epididymal sperm retrieval)
    Non ejaculated spermatozoa (testicular or epididymal sperm retrieval) (for example: Azoospermia and cryptoazoospermia)
    cases in which the sperm cells were not bound to the zona pellucida for any reason
    Women with polycystic ovary syndrome
    اسپرم های غیر انزالی (تسه و میکروتسه)
    اسپرم های غیر انزالی (تسه و میکروتسه) ( به عنوان مثال مردان آزوسپرمی و کریپتوزواسپرمی)
    مواردی که اسپرم به زونا پلوسیدا تخمک به هر دلیلی متصل نمیشد .
    خانم های مبتلا به سندرم تخمدان پلی سیستیک
    one sample of sperm is collected from an individual infertile male.
    empty
    از هر مرد نابارور فقط یک نمونه اسپرم گرفته می شود
    empty

  • Primary outcomes

    #1
    Rate of implantation
    empty
    میزان لانه گزینی
    empty
    Rate of implantation is evaluated 1 weeks after assisted reproductive technique.
    empty
    میزان لانه گزینی یک هفته پس از تکنیک کمک باروری ارزیابی می شود
    empty
    Rate of implantation is determined by observation of gestational sac through the vaginal sonography.
    empty
    لانه گزینی با تشکیل ساک حاملگی و شناسایی آن با سونوگرافی واژینال مشخص می شود
    empty

  • Secondary outcomes

    #1
    Rate of embryo transfer
    time lapse parameters
    میزان انتقال جنین
    پارامترهای مربوط به تایم لپس
    Three days after performing of assisted reproductive technique
    After intracytoplasmic injection of sperm (time 0), the following time points are measured: Time of disappearance of pronucleus in zygote (tPNF), Zygote divides into two cells (T2), three cells (T3), four cells (T4), five cells (T5), six cells (T6), seven cells (T7) and eight cells (T8).
    روز سوم پس از انجام تکنیک کمک باروری
    پس ازتزریق داخل سیتوپلاسمی اسپرم (زمان صفر)، نقاط زمانی زیر اندازه گیری می شود: زمان ناپدید شدن پرونوکلئوس در زایگوت (tPNF)، زمان تقسیم شدن زایگوت به دوسلول (T2)، سه سلول (T3), چهارسلول(T4), پنج سلول (T5)، شش سلول (T6)، هفت سلول (T7) و هشت سلول (T8).
    Number of transferred embryo
    Analyzing and measurement using EmbryoViewerTM software
    تعداد جنین های انتقال داده شده
    تحلیل و اندازه گیری با نرم افزارسیستم تایم لپس
    #2
    Rate of embryo zona pellucida integrity
    Rate of implantation
    میزان انسجام زونا پلوسیدا جنین
    میزان لانه گزینی
    Three days after performing of assisted reproductive technique
    The rate of implantation is assessed 1 week to 10 days after the assisted reproduction technique.
    روز سوم پس از انجام تکنیک کمک باروری
    میزان لانه گزینی یک هفنه تا ده روز پس از تکنیک کمک باروری ارزیابی می شود
    observation of zona pellucda structure by polarizing microscope
    Rate of implantation is determined by observation of gestational sac through the vaginal sonography.
    مشاهده ساختار زونا پلوسیدا بوسیله میکروسکپ پلاریزان
    لانه گزینی با تشکیل ساک حاملگی و شناسایی آن با سونوگرافی واژینال مشخص می شود.

  • Recruitment centers

    #1
    Name of recruitment center - English: Infertility Research Center - Shahid Sadoughi University of Medical Sciences.YAZD
    Name of recruitment center - Persian: مرکز تحقیقات ناباروری -دانشگاه علوم پزشکی شهید صدوقی یزد
    Full name of responsible person - English: Abbas Aflatoonian
    Full name of responsible person - Persian: عباس افلاطونیان
    Street address - English: یزد، صفائیه، خیابان بوعلی
    Street address - Persian: یزد، صفائیه، خیابان بوعلی
    City - English: YAZD
    City - Persian: یزد
    Province: Yazd
    Country: Iran (Islamic Republic of)
    Postal code: 8916877391
    Phone: +98 35 3824 8119
    Fax:
    Email: mizadi890112@gmail.com
    Web page address:
    Name of recruitment center - English: Infertility Research Center; Shahid Sadoughi University of Medical Sciences; Yazd
    Name of recruitment center - Persian: مرکز تحقیقات ناباروری -دانشگاه علوم پزشکی شهید صدوقی یزد
    Full name of responsible person - English: Abbas Aflatoonian
    Full name of responsible person - Persian: عباس افلاطونیان
    Street address - English: Bouali street; Safaieh
    Street address - Persian: صفائیه، خیابان بوعلی
    City - English: Yazd
    City - Persian: یزد
    Province: Yazd
    Country: Iran (Islamic Republic of)
    Postal code: 8916877391
    Phone: +98 35 3824 8119
    Fax:
    Email: mizadi890112@gmail.com
    Web page address:

  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Masoud Mirzaei
    Full name of responsible person - Persian: مسعود میرزایی
    Street address - English: Safaieh, Bouali Street
    Street address - Persian: صفاییه ،خیابان بوعلی
    City - English: Yazd
    City - Persian: یزد
    Province: Yazd
    Country: Iran (Islamic Republic of)
    Postal code: 8916877391
    Phone: +98 35 3824 8119
    Fax:
    Email: mizadi890112@gmail.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Masoud Mirzaei
    Full name of responsible person - Persian: مسعود میرزایی
    Street address - English: Bouali Street; Safaieh
    Street address - Persian: صفاییه ،خیابان بوعلی
    City - English: Yazd
    City - Persian: یزد
    Province: Yazd
    Country: Iran (Islamic Republic of)
    Postal code: 8916877391
    Phone: +98 35 3824 8119
    Fax:
    Email: mizadi890112@gmail.com
    Web page address:

Protocol summary

Study aim
Determination of embryocytokinetic and outcomes of intracytoplasmic sperm injection using sperms bound to the zona pellucida of immature oocytes
Design
This study is designed as a clinical trials with parallel control and intervention groups. Sperms are derived from main sperm sample that gathered from male patient. Blindness has not been performed and study has been performed on 50 infertile couples.
Settings and conduct
location of this research is the Research and Clinical Center for Infertility, faculty of medicine, Shahid Sadoughi University of Medical Sciences, Yazd, Iran
Participants/Inclusion and exclusion criteria
Inclusion criteria: less than 40 years old; at least six MII oocytes and one meta phase I oocyte retrieved; Semen samples with sperm concentration more than 5 million motile spermatozoa/ml. Non-inclusion criteria: Non ejaculated spermatozoa (testicular or epididymal sperm retrieval).
Intervention groups
Each patient's oocyte are divided into control and target groups Intervention group 1: intracytoplasmic sperm injection usingsperm bound to the zona pellucida of immature oocytes control group :conventional intracytoplasmic sperm injection
Main outcome variables
Rate of implantation; Clinical pregnancy rate

General information

Reason for update
1- The reason for changing the start time of the study was that we had to start work after the production of IRCT approval. 2- Remove of one of the secondary outcome named integration of embryo zona pellucida was that the embryos would not be out of the incubator for longer than necessary. 3- Primary and secondary outcomes updated. 4-The target sample size was updated (after statistical study, the decision was made to change).
Acronym
IRCT registration information
IRCT registration number: IRCT20200705048021N1
Registration date: 2020-09-01, 1399/06/11
Registration timing: prospective

Last update: 2022-04-18, 1401/01/29
Update count: 1
Registration date
2020-09-01, 1399/06/11
Registrant information
Name
Mahin Izadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3720 8965
Email address
mizadi890112@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-26, 1399/12/08
Expected recruitment end date
2022-02-28, 1400/12/09
Actual recruitment start date
2020-10-28, 1399/08/07
Actual recruitment end date
2022-01-05, 1400/10/15
Trial completion date
2022-04-23, 1401/02/03
Scientific title
Comparison of the effects of sperm selection using sperm bounded to zona pellusida of immature oocyte and sperm selection by current methods on embryo morphokinitic and clinical fertility outcomes in infertile couples
Public title
Effects of sperm selection by zona pellucida binding method on fertility outcomes and embryo morphokinitics
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age less than 40 years old At least six MII oocytes and one metaphase I oocyte retrieved Spouse semen samples with sperm concentration more than 5*106 motile spermatozoa
Exclusion criteria:
Non ejaculated spermatozoa (testicular or epididymal sperm retrieval) (for example: Azoospermia and cryptoazoospermia) cases in which the sperm cells were not bound to the zona pellucida for any reason Women with polycystic ovary syndrome
Age
To 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
Actual sample size reached: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Simple random allocation is used for randomization. In this way, one of the two completely identical balls with numbers 1 or 2 in a lottery container is randomly selected and then with the arrival of ball 1, the sample is allocated to the control group and the ball 2 is allocated to the intervention group.
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
Yazd Reproductive Sciences Research Institute; Bouali street; Safaieh
City
Yazd
Province
Yazd
Postal code
8916877391
Approval date
2019-09-15, 1398/06/24
Ethics committee reference number
IR.SSU.RSI.REC.1398.022

Health conditions studied

1

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

Primary outcomes

1

Description
Rate of clinical pregnancy
Timepoint
Rate of clinical pregnancy is evaluated 6 weeks after assisted reproductive technique.
Method of measurement
Clinical pregnancy is measured through the recording of heart beat by ultrasonography.

Secondary outcomes

1

Description
Fertilization rate
Timepoint
Sixteen to 20 hours after performing of assisted reproductive technique.
Method of measurement
Appearance of pronucleus by binocular loop observation

2

Description
Embryo quality
Timepoint
Three days after performing of assisted reproductive technique
Method of measurement
Total number of normal blastomer and percent of fragmented blastomer in defined time points using Time-Laps system.

3

Description
Rate of chemical pregnancy
Timepoint
Two weeks after performing of assisted reproductive technique
Method of measurement
Measurement of serum Beta-Human Chorionic Gonadotropin

4

Description
time lapse parameters
Timepoint
After intracytoplasmic injection of sperm (time 0), the following time points are measured: Time of disappearance of pronucleus in zygote (tPNF), Zygote divides into two cells (T2), three cells (T3), four cells (T4), five cells (T5), six cells (T6), seven cells (T7) and eight cells (T8).
Method of measurement
Analyzing and measurement using EmbryoViewerTM software

5

Description
Rate of implantation
Timepoint
The rate of implantation is assessed 1 week to 10 days after the assisted reproduction technique.
Method of measurement
Rate of implantation is determined by observation of gestational sac through the vaginal sonography.

Intervention groups

1

Description
Intervention group: intracytoplasmic sperm injection using the zonapellucida-bound sperm to immature oocyte.
Category
Treatment - Other

2

Description
Control group: conventional intracytoplasmic sperm injection
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
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 8119
Email
mizadi890112@gmail.com

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
mizadi890112@gmail.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
Safaieh, Bouali Street
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
Mahin Izadi
Position
P.hd student
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Biology
Street address
Safaieh, Bouali Street
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3720 8965
Email
mizadi890112@gmail.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 that will be shared with other researchers after removing the identification data of participants: 1- Fertilization rate by examining the formation of proenucleus in the egg cell. 2- Assessment of embryo quality and morphokinetics by the time lapse system and calculating the time related to the process of cell division of the embryo. 3- Chemical and clinical pregnancies one week and seven weeks, respectively, after embryo transfer.
When the data will become available and for how long
Up to one year after publication the results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Again with the consent of the participants and the researcher responsible for the project
From where data/document is obtainable
Mohammad Ali Khalili 09133570876 Khalili59@hotmail.com
What processes are involved for a request to access data/document
Send a request via email to the responsible researcher
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