Investigating changes in sperm motility and expression levels of Dazl, Pmca4 and Bcl2 genes in asthenospermic individuals under the influence of zinc gluconate (ZG) supplementation
Investigating the expression levels of Dazl, Pmca4 and Bcl2 genes in asthenosperm individuals under the influence of zinc
Design
The clinical trial has a control group and an experimental group, two-way blinding was performed, the study was phase 2 and was performed on 60 patients. Random allocation was done using Excel software.
Settings and conduct
This research was conducted from 2019 to 2020 in Milad Fertility Clinic, Mashhad, (Iran) to evaluate and study the therapeutic effect of ZG administration on infertile men with asthenoteraspermia.The sample size was considered to be 30 people based on previous studies. According to the group they are in, they will receive ZG 30 mg per day for 3 months. people participating in the research and analyzing the data were blinded. Sperm samples were taken before and after the course and then evaluated.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Men in the age range of 20 to 50 years who, according to expert opinion and based on WHO criteria, disorders related to asthenoteratospermia in sperm parameters were observed at an interval of 2 weeks
Exclusion criteria:
- People who had other special diseases and were diagnosed by a urologist and mentioned in their medical records.
- Men who had taken special medicine or drugs in the last three months.
Intervention groups
The study was conducted on astheno-spermic individuals and the groups were divided and compared as follows:
Intervention group 1 (control): patients with asthenospermia who received placebo.
Intervention group 2 (experimental): patients with asthenospermia who received zinc gluconate supplementation.
Main outcome variables
Sperm motility
General information
Reason for update
Acronym
زینک گلوکونات یا zinc gluconate (ZG)
IRCT registration information
IRCT registration number:IRCT20230205057334N1
Registration date:2023-09-10, 1402/06/19
Registration timing:retrospective
Last update:2023-09-10, 1402/06/19
Update count:0
Registration date
2023-09-10, 1402/06/19
Registrant information
Name
Kiandokht Khoohestanian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3893 2176
Email address
kian.dokht222@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-26, 1398/06/04
Expected recruitment end date
2020-08-27, 1399/06/06
Actual recruitment start date
2019-08-27, 1398/06/05
Actual recruitment end date
2021-01-21, 1399/11/02
Trial completion date
2021-02-20, 1399/12/02
Scientific title
Investigating changes in sperm motility and expression levels of Dazl, Pmca4 and Bcl2 genes in asthenospermic individuals under the influence of zinc gluconate (ZG) supplementation
Public title
Investigating the effect of zinc gluconate on sperm motility
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Infertile men, despite having at least one year of unprotected intercourse, natural fertility did not occur in their wives.
All men were married and in the age range of 20 to 50 years.
According to the expert's opinion and based on the WHO criteria, disorders related to asthenotaratospermia should have been observed in the sperm parameters of at least two samples of their sperm analysis with an interval of 2 weeks.
Exclusion criteria:
single men
People who had varicocele or other special disease and were diagnosed by a urologist and mentioned in their medical records.
Men who had taken special medicine or drugs in the last three months.
Infertile men who were not diagnosed by a neurogonadal specialist
Participating in another study at the same time
Age
From 20 years old to 50 years old
Gender
Male
Phase
2
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
40
More than 1 sample in each individual
Number of samples in each individual:
2
ejaculate sperm sample
Actual sample size reached:
30
More than 1 sample in each individual
Actual sample size in each individual:
2
ejaculate sperm sample
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
This means that none of the patients know whether they have taken the drug or the placebo (the drug and the placebo were similar in terms of shape, color, and method of administration).
The data analyst was also unaware of what the patients had consumed
In the end, the spermogram information of each individual was only
available to that person if necessary.
The drug and placebo were similar in terms of shape, color, and method of administration, so blinding can be done at the participant level.
Placebo
Used
Assignment
Parallel
Other design features
In this study, asthenospermic individuals referred to the infertility center were divided into two intervention groups 1 (control), which included asthenospermic individuals who consumed placebo for 90 days, and intervention group 2 (experimental), which included asthenospermic individuals who consumed zinc gluconate supplements for 90 days.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of mashhad azad university
Street address
Mashhad, Sayad Shirazi Boulevard, Plate 42, Unit 4
City
mashhad
Province
Razavi Khorasan
Postal code
9177735868
Approval date
2019-04-05, 1398/01/16
Ethics committee reference number
IR.IAU.MSHD.REC.1398.199
Health conditions studied
1
Description of health condition studied
Asthenospermia
ICD-10 code
R86.9
ICD-10 code description
Unspecified abnormal finding in specimens from male genital organs
Primary outcomes
1
Description
sperm motility
Timepoint
In this study, the effect of zinc gluconate supplementation on sperm motility after 90 days of starting to take this supplement was performed on asthenospermic subjects.
Method of measurement
spermogram reports of the patients .
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 30 people with asthenospermia who received zinc gluconate supplement (from Simorgh Daru Company) at a dose of 30 mg daily for 90 days.
Category
Treatment - Drugs
2
Description
Control group: 30 people with asthenospermia who received placebo daily for 90 days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Milad Infertility Center, Mashhad, Iran
Full name of responsible person
Kiandokht Koohestanian
Street address
Sayad Shirazi St., Block 42, Unit 4
City
Mashhad
Province
Razavi Khorasan
Postal code
9177735868
Phone
+98 935 972 7655
Email
kian.dokht222@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Kiandokht Koohestanian
Street address
Sayad Shirazi St., Block 42, Unit 4
City
Mashhad
Province
Razavi Khorasan
Postal code
9177735868
Phone
+98 935 972 7655
Email
kian.dokht222@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Mashhad Azad University
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Kiandokht Koohestanian
Position
Student
Latest degree
Master
Other areas of specialty/work
Reproductive Health
Street address
11 Sayad St., No. 42, Unit 4
City
Mashhad
Province
Razavi Khorasan
Postal code
9177735868
Phone
+98 935 972 7655
Email
kian.dokht222@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Kiandokht Koohestanian
Position
student
Latest degree
Master
Other areas of specialty/work
Reproductive Biology
Street address
11 Sayad St., No. 42, Unit 4
City
Mashhad
Province
Razavi Khorasan
Postal code
9177735868
Phone
+98 935 972 7655
Email
kian.dokht222@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Kiandokht Koohestanian
Position
student
Latest degree
Master
Other areas of specialty/work
Reproductive Biology
Street address
11 Sayad St., No. 42, Unit 4
City
Mashhad
Province
Razavi Khorasan
Postal code
9177735868
Phone
+98 935 972 7655
Email
kian.dokht222@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
Yes - There is 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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Clinical reports of changes in spermogram and the effect of the drug used in intervention group 2 in this study can be shared after the individuals cannot be identified.
When the data will become available and for how long
6 months after the results are published
To whom data/document is available
For researchers and people working in the food and drug industry
Under which criteria data/document could be used
In order to make the dimensions of the research more complete, the documents of this study can be used
From where data/document is obtainable
Refer to the author's email address
Kiandokht Kohstanian :(kian.dokht222@gmail.com)
What processes are involved for a request to access data/document
Sending an email to the authors of the article and explaining the commonality of the research with their proposed plan. The applicant will receive the answer after a week.