Evaluation of the effectiveness of frankincense oleogum resin on improving sperm motility in men with asthenospermia
Design
This study is a double-blind clinical trial with control group and intervention group in which 50 patients are randomly assigned to one of these two groups.
Settings and conduct
The study site is Yazd Infertility Research and Treatment Center
Participants/Inclusion and exclusion criteria
Inclusion criteria include willingness to cooperate, at least one year has passed since the decision to have a child and not to use contraceptives, men 20 to 45 years old, asthenospermia of unknown cause (idiopathic) according to the criteria of the World Health Organization and exclusion criteria including men with infertility with a specific cause (such as hormonal disorders), infertility of the wife, drug and alcohol use, underlying diseases like diabetes, kidney disease, chronic liver disease
Intervention groups
The control group receives a placebo and the intervention group receives a capsule containing frankincense
Main outcome variables
Sperm motility
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140817018828N7
Registration date:2020-08-24, 1399/06/03
Registration timing:registered_while_recruiting
Last update:2020-08-24, 1399/06/03
Update count:0
Registration date
2020-08-24, 1399/06/03
Registrant information
Name
Alimohammad Ranjbar
Name of organization / entity
Yazd University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 3820 3419
Email address
amranjbar@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-24, 1399/06/03
Expected recruitment end date
2020-12-23, 1399/10/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Boswellia serrata Roxb. ex Colebr. oleogum resin on sperm motility in men with sperm motility defects (asthenospermia)
Public title
Evaluation of the effect of Boswellia serrata Roxb. ex Colebr. oleogum resin on sperm motility in men with sperm motility defects (asthenospermia)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to cooperate
At least one year has passed since the decision to have a child and not to use contraceptives
Idiopathic asthenospermia according to WHO criteria
Exclusion criteria:
Men with infertility with a specific cause (such as hormonal disorders)
Infertility of the wife
Drug and alcohol use
Having underlying diseases such as diabetes, kidney disease (creatinine more than 2 times), chronic liver disease
Taking antioxidant supplements in the last three months
Age
From 20 years old to 45 years old
Gender
Male
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Limited randomization according to the law of random allocation in such a way that out of 50 cases, 25 people were selected by lot for the group receiving frankincense and the rest were placed in the group receiving placebo. Allocation concealment was performed by opaque seals in random sequence.
Ethics Committee in Research of Shahid Sadoughi Medical School of Yazd
Street address
Profesor hesabi Blvd.
City
Yazd
Province
Yazd
Postal code
8915173149
Approval date
2019-11-03, 1398/08/12
Ethics committee reference number
IR.SSU.MEDICINE.REC.1398.216
Health conditions studied
1
Description of health condition studied
Asthenospermia
ICD-10 code
R86.9
ICD-10 code description
asthenospermia
Primary outcomes
1
Description
Sperm motility
Timepoint
Before the intervention and 84 days after taking the drug or placebo
Method of measurement
Sperm test
Secondary outcomes
empty
Intervention groups
1
Description
Control group: This group receives 2 placebo capsules containing cellulose per day for 84 days. In addition to this treatment, patients take 1 tablet of folic acid 5 mg daily
Category
Treatment - Drugs
2
Description
Intervention group: This group takes 2 capsules a day containing 500 mg of frankincense for 84 days. In addition to this treatment, patients take 1 tablet of folic acid 5 mg daily
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd Infertility Center
Full name of responsible person
Seyed Alimohammad Mirjalili
Street address
Bou ali Ave., Timsar fallahi Ave.
City
Yazd
Province
Yazd
Postal code
000
Phone
+98 35 3824 7085
Email
ivf@ssu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Hooshang Mehrparvar
Street address
Bahonar Square, Yazd, Iran
City
Yazd
Province
Yazd
Postal code
8917693571
Phone
+98 35 3724 0171
Email
ah.mehrparvar@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
Alimohamad Ranjbar Jamal abadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Professor Hesabi Boolvar, Yazd, Iran
City
Yazd
Province
Yazd
Postal code
8915173149
Phone
+98 35 3820 3419
Fax
Email
amranjbar@razi.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Alimohamad Ranjbar Jamal abadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Professor Hesabi Boolvar, Yazd, Iran
City
Yazd
Province
Yazd
Postal code
8915173149
Phone
+98 35 3820 3419
Fax
Email
amranjbar@razi.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Fateme Paydar
Position
Pharmacy student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
The end of Professor Hesabi Boulevard
City
yazd
Province
Yazd
Postal code
8915173149
Phone
+98 35 3820 3419
Email
fatemeh75paydar@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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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