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Comparison of the effect of pentoxifylline on sperm structure ,embryo morphokinetics resulting from these sperms and clinical outcomes compared to the control group in azoospermic patients

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History
# Registration date Revision Id
4 2022-04-18, 1401/01/29 223217
3 2022-03-18, 1400/12/27 222137
2 2021-03-05, 1399/12/15 220316
1 2020-09-07, 1399/06/17 150016
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  • Protocol summary

    Each person's sperm sample is divided into two parts: control group:Addition of 1.72 mmol pentoxifylline to a drop of containing sperm sample interventional group: No intervention is made
    Each person's sperm sample is divided into two parts: control group:Addition of 3.6 mmol pentoxifylline to a drop of containing sperm sample interventional group: No intervention is made
    نمونه اسپرم هر فرد دو قسمت می شود: گروه مداخله: افزودن 1.72 میلی مول پنتوکسی فیلین به قطره حاوی نمونه اسپرم گروه کنترل: هیچ مداخله ای صورت نمی گیرد
    نمونه اسپرم هر فرد دو قسمت می شود: گروه مداخله: افزودن 3.6 میلی مول پنتوکسی فیلین به قطره حاوی نمونه اسپرم گروه کنترل: هیچ مداخله ای صورت نمی گیرد

  • General information

    Comparison of the effect of pentoxifylline on sperm structure ,embryos resulting from these sperms and clinical outcomes compared to the control group in azoospermic patients
    Comparison of the effect of pentoxifylline on sperm structure ,embryo morphokinetics resulting from these sperms and clinical outcomes compared to the control group in azoospermic patients
    مقایسه تاثیر پنتوکسی فیلین بر روی فراساختار اسپرم، جنین های حاصل از این اسپرمها و نتایج بالینی نسبت به گروه کنترل در بیماران آزواسپرم
    مقایسه تاثیر پنتوکسی فیلین بر روی فراساختار اسپرم، مورفوکینتیک جنین های حاصل از این اسپرمها و نتایج بالینی نسبت به گروه کنترل در بیماران آزواسپرم
    Each person's sperm sample is divided into two parts: control group:Addition of 1.72 mmol pentoxifylline to a drop of containing sperm sample interventional group: No intervention is made
    Each person's sperm sample is divided into two parts: control group:Addition of 3.6 mmol pentoxifylline to a drop of containing sperm sample interventional group: No intervention is made
    نمونه اسپرم هر فرد دو قسمت می شود: گروه مداخله: افزودن 1.72 میلی مول پنتوکسی فیلین به قطره حاوی نمونه اسپرم گروه کنترل: هیچ مداخله ای صورت نمی گیرد
    نمونه اسپرم هر فرد دو قسمت می شود: گروه مداخله: افزودن 3.6 میلی مول پنتوکسی فیلین به قطره حاوی نمونه اسپرم گروه کنترل: هیچ مداخله ای صورت نمی گیرد

  • Primary outcomes

    #1
    Time Lapse Incubator
    formation of 2 pronucleous
    انکوباتور تایم لپس
    تشکیل دو عدد پرونکلئوس
    #2
    Time Lapse Incubator
    8 cell embryo formation
    انکوباتور تایم لپس
    تشکیل جنین 8 سلولی
    #3
    From the time of artificial insemination until the time of embryo transfer to the mother's uterus
    From the time of pronucleous formation until the time of embryo transfer to the mother's uterus
    از زمان کمک باروری مصنوعی تا زمان انتقال جنین به رحم مادر
    از زمان تشکیل پرونکلئوسها تا زمان انتقال جنین به رحم مادر

  • Intervention groups

    #1
    Intervention group: Addition of 1.72 mmol pentoxifylline to a drop of containing sperm sample and selection of motile sperm
    Intervention group: Addition of 3.6 mmol pentoxifylline to a drop of containing sperm sample and selection of motile sperm
    گروه مداخله: افزودن 1.72 میلی مول پنتوکسی فیلین به قطره حاوی نمونه اسپرم و انتخاب اسپرم متحرک
    گروه مداخله: افزودن 3.6 میلی مول پنتوکسی فیلین به قطره حاوی نمونه اسپرم و انتخاب اسپرم متحرک

Protocol summary

Study aim
Assessment of the effect of in vitro application of pentoxifylline on ultrastructure and DNA of spermatozoa, embryo morphokinetics and clinical outcomes in azoospermic patients
Design
Clinical trial with parallel control and intervention groups, no blinding, study on 40 azoosperm patients
Settings and conduct
Among the patients referring to Yazd Infertility Center, 40 testicular samples randomly will be selected in patients with azoospermia. Male factor infertility was the main diagnosis for all couples and all patients will receive written consent.to be involved in the study protocol.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Non obstructive azoospermia patient younger than 50 years and more than 50 number sperm women less than 40 years old without any Infertility problems Exclusion criteria: HIV- positive patient with any pathology Patients with very low sperm count
Intervention groups
Each person's sperm sample is divided into two parts: control group:Addition of 3.6 mmol pentoxifylline to a drop of containing sperm sample interventional group: No intervention is made
Main outcome variables
chemical pregnancy rate clinical pregnancy rate

General information

Reason for update
Azoosperm patients included in the study with both fresh and frozen samples.
Acronym
IRCT registration information
IRCT registration number: IRCT20200705048020N1
Registration date: 2020-09-07, 1399/06/17
Registration timing: prospective

Last update: 2022-04-19, 1401/01/30
Update count: 3
Registration date
2020-09-07, 1399/06/17
Registrant information
Name
Maryam Mahaldashtian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 4333 4693
Email address
mahaldashtian.m@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
2021-03-09, 1399/12/19
Actual recruitment end date
2022-02-28, 1400/12/09
Trial completion date
2022-02-28, 1400/12/09
Scientific title
Comparison of the effect of pentoxifylline on sperm structure ,embryo morphokinetics resulting from these sperms and clinical outcomes compared to the control group in azoospermic patients
Public title
Evaluation the effect of Pentoxifylline on spermatozoa of Azoospermic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All non obstructive azoospermia patients less than 50 years old and more than 50 number sperm women less than 40 years old without any Infertility problems
Exclusion criteria:
HIV- positive patient with any pathology Patients with very low sperm count women more than 40 years old Couples who also have problems with female infertility
Age
From 20 years old to 50 years old
Gender
Male
Phase
4
Groups that have been masked
No information
Sample size
Target sample size: 40
More than 1 sample in each individual
Number of samples in each individual: 2
Each person's sperm sample is divided into two parts: control group:Addition of 3.6 mmol pentoxifylline to a drop of containing sperm sample interventional group: No intervention is made
Actual sample size reached: 57
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
2019-08-26, 1398/06/04
Ethics committee reference number
IR.SSU.RSI.REC.1398.013

Health conditions studied

1

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

Primary outcomes

1

Description
Fertilization rate
Timepoint
One day after assisted artificial insemination
Method of measurement
formation of 2 pronucleous

2

Description
Embryo formation rate
Timepoint
3 days after assisting artificial insemination
Method of measurement
8 cell embryo formation

3

Description
Embryo morphokinetic rate
Timepoint
From the time of pronucleous formation until the time of embryo transfer to the mother's uterus
Method of measurement
Time Lapse Incubator

4

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
Intervention group: Addition of 3.6 mmol pentoxifylline to a drop of containing sperm sample and selection of motile sperm
Category
Treatment - Drugs

2

Description
Control group: No intervention is made
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
mahaldashtian.m@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
mahaldashtian.m@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
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
maryam mahaldashtian
Position
PhD student
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
mahaldashtian.m@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: 1) Fertility rate, by examining the formation of proonucleus in the egg cell 2) Checking the embryo quality and morphokinetic using time lapse system 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 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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