Evaluation of the effect of vitamin D therapy on asthenospermia in infertile patients with vitamin D insufficiency who refer to Ghaem Hospital's medical clinics
Design
Clinical trial with control and intervention group, with parallel, two-way blind, randomized groups
Settings and conduct
Patients with asthenospermia referred to the treatment clinics of Ghaem Hospital in Mashhad. Patients with asthenospermia and insufficiency of vitamin D are included in the study. Patients with serum levels below 20 (deficiency) are excluded from the intervention and are recommended to complete treatment for vitamin D deficiency. After exclusion criteria and randomized patients (using simple computer randomization), patients are divided into two groups. In the control group, common treatments are performed to correct spermogram. And for vitamin D insufficiency, It is only recommended to change and correct the lifestyle. In the intervention group, In addition to the items listed in the control group, With vitamin D Perl, is taken at a dose of 5,000 units per week for up to 8 weeks. After three months, vitamin D levels are measured again in both groups. Six months after the start of the study, Again vitamin D levels and new spermograms in both groups will be compared and analyzed.
Participants/Inclusion and exclusion criteria
Inclusion of Criteria: 1. Asthenospermia. 2. Insufficient vitamin D. 3- Age 18-50
Exclusion criteria: Existence of other organic diseases such as varicocele, Genetic disorder and clinical syndrome
Intervention groups
In the intervention group, in addition to routine infertility treatments, vitamin D deficiency is treated with prescription vitamin D perl and its effect on spermogram is investigated. In the control group, only routine infertility treatments are performed.
Main outcome variables
Correction of asthenospermia; Correction of vitamin D insufficiency; Correction of infertility.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200412047046N1
Registration date:2020-04-25, 1399/02/06
Registration timing:retrospective
Last update:2020-04-25, 1399/02/06
Update count:0
Registration date
2020-04-25, 1399/02/06
Registrant information
Name
Iman Broomand
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3843 2256
Email address
broumandi951@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-23, 1398/06/01
Expected recruitment end date
2020-02-20, 1398/12/01
Actual recruitment start date
2019-08-23, 1398/06/01
Actual recruitment end date
2020-03-10, 1398/12/20
Trial completion date
2020-03-10, 1398/12/20
Scientific title
Evaluation of the effect of vitamin D therapy on asthenospermia in infertile patients with vitamin D insufficiency
Public title
Investigation of the effect of vitamin D treatment on asthenospermia in infertile patients with vitamin D insufficiency
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Asthenospermia
Vitamin D insufficiency (20-30)
Age 18-50
Exclusion criteria:
Normalization levels of vitamin D in the control group
The presence of other organic diseases such as varicocele ٔ and genetic disorders and clinical syndrome
Age
From 18 years old to 50 years old
Gender
Male
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
60
Actual sample size reached:
65
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization
Randomization Method: Excel software or other randomization websites.
Allocation Concealment: Opaque envelope
Blinding (investigator's opinion)
Double blinded
Blinding description
1-Participants do not know are they In which group.
2-Evaluators do not know the data belongs to which group
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Ghoreisi building, next to Hoveize cinema, Daneshgah Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2019-08-13, 1398/05/22
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1398.432
Health conditions studied
1
Description of health condition studied
Asthenospermia; Vitamin D insufficiency
ICD-10 code
N46
ICD-10 code description
Male infertility
Primary outcomes
1
Description
Asthenospermia (sperm motility factor in WHO criteria for motility less than a + b <30)
Timepoint
perform spermograms at the beginning of the study and then six months later
Method of measurement
To perform a spermogram, should be performed at least 3 days and maximum 5 days after the last ejaculation . The patient's spermogram will be tested in a same reference center by an experienced operator
2
Description
Insufficiency of vitamin D (between 20-30)
Timepoint
At the beginning of the study, three and a six months later
Method of measurement
In these patients, serum levels of vitamin D are measured through Anterior veins of the forearm from a blood sample.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention Group: In addition to prescribing routine infertility treatments, prescribing Perl Vitamin D 5,000 units once a week for 8 weeks
Category
Treatment - Drugs
2
Description
Control group: In the control group, routine infertility treatments are performed and The patient is also advised to change their lifestyle to improve their vitamin D levels by sunbathing and changing their diet.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Gaem hospital
Full name of responsible person
Alireza Akhavanrezayat
Street address
Urology department, Ghaem hospital, Ahmad abad Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3843 2256
Email
Akhavanra@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Ghoreishi building, next to Hoveize cinema, Daneshgah Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
vcresraech@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Alireza Akhavanrezayat
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Urology department, Ghaem hospital, Ahmad abad Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3843 2256
Email
akhavanra@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Alireza Akhavanrezayat
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Urology department, Ghaem hospital, Ahmad abad Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3843 2256
Email
akhavanra@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Alireza Akhavanrezayat
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Urology department, Ghaem hospital, Ahmad abad Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3843 2256
Email
akhavanra@mums.ac.ir
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
Yes - There is 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
After making participants unrecognizable, all variables can be shared
When the data will become available and for how long
Start of access period from 1400 ( 2021, April)
To whom data/document is available
The data of this study will be available to all people in different environments and in related fields.
Under which criteria data/document could be used
Data should be used to produce science.
Data should be used to improve treatment conditions.
From where data/document is obtainable
1) Dr. Alireza Akhavanrezayat; e-mail: akhavana@mums.ac.ir.
2) Dr. Iman Broomand; e-mail: iman.broomand@icloud.com
What processes are involved for a request to access data/document
After the mentioned time, regarding the availability of data, the applicant can announce her request by e-mail and receive a response within 3 months.