Protocol summary
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Study aim
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Assessment of the effect of in vitro application of pentoxifylline on ultrastructure and DNA of spermatozoa, embryo morphokinetics and clinical outcomes in azoospermic patients
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Design
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Clinical trial with parallel control and intervention groups, no blinding, study on 40 azoosperm patients
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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
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Main outcome variables
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chemical pregnancy rate
clinical pregnancy rate
General information
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Reason for update
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Azoosperm patients included in the study with both fresh and frozen samples.
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Acronym
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IRCT registration information
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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
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Registration date
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2020-09-07, 1399/06/17
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-02-26, 1399/12/08
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Expected recruitment end date
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2022-02-28, 1400/12/09
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Actual recruitment start date
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2021-03-09, 1399/12/19
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Actual recruitment end date
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2022-02-28, 1400/12/09
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Trial completion date
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2022-02-28, 1400/12/09
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Scientific title
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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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Public title
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Evaluation the effect of Pentoxifylline on spermatozoa of Azoospermic patients
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 20 years old to 50 years old
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Gender
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Male
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Phase
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4
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Groups that have been masked
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No information
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Sample size
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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
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Randomization (investigator's opinion)
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N/A
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Randomization description
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-08-26, 1398/06/04
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Ethics committee reference number
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IR.SSU.RSI.REC.1398.013
Health conditions studied
1
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Description of health condition studied
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azoospermia
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ICD-10 code
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N46
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ICD-10 code description
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Male infertility
Primary outcomes
1
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Description
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Fertilization rate
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Timepoint
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One day after assisted artificial insemination
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Method of measurement
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formation of 2 pronucleous
2
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Description
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Embryo formation rate
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Timepoint
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3 days after assisting artificial insemination
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Method of measurement
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8 cell embryo formation
3
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Description
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Embryo morphokinetic rate
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Timepoint
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From the time of pronucleous formation until the time of embryo transfer to the mother's uterus
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Method of measurement
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Time Lapse Incubator
4
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Description
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Chemical pregnancy rate
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Timepoint
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One week after the embryo transfer to the uterus
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Method of measurement
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Blood βHCG Measurement
Secondary outcomes
1
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Description
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Clinical pregnancy rate
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Timepoint
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7 weeks after embryo transfer to the uterus
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Method of measurement
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Assessment of cardiovascular formation using ultrasound examination
Intervention groups
1
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Description
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Intervention group: Addition of 3.6 mmol pentoxifylline to a drop of containing sperm sample and selection of motile sperm
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Category
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Treatment - Drugs
2
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Description
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Control group: No intervention is made
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Category
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Treatment - Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Yazd University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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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
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When the data will become available and for how long
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Up to one year after publication of the article
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To whom data/document is available
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Researchers working in academic and scientific institutions
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Under which criteria data/document could be used
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With the re-consent of the participant and the researcher responsible of the project
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From where data/document is obtainable
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mohammad ali khalili
09133570876
khalili59@hotmail.com
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What processes are involved for a request to access data/document
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Send a request via email to the responsible researcher
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Comments
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