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Effect of Spirulina microalgae on Semen Parameters in Men with Idiopathic Infertility

Protocol summary

Summary
Based on several claims on the positive effect of spirulina migroalgae in the treatment of male infertility, this study is aimed to assess the effect of spirulina microalgae on semen parameters in men with idiopathic infertility. Inclusion criteria included idiopathic infertility (abnormal sperm motility and morphology based on WHO index), evidence of wife fertility, and age 20-40 year. The patients with medical situation or surgery that can cause infertility, previous history of chemotherapy, history of varicocel of cryptorchidism, body mass index 30kg/m2 or greater, alcohol, drugs or other substance abuse, history of androgen or anti-androgen drugs consumption, severe kidney insufficiency (serum creatinine greater than 2.0 mg/dl), sever liver insufficiency (serum bilirubin greater than 2.0 mg/dl), azoospermia, and immune-suppressant drugs usage were excluded. Forty males with idiopathic infertility will be randomly assigned into two groups. The intervention group will receive 2g spirulina plus standard therapy for indiopathic infertility (L-carnitine, zinc sulfate, and 50mg/day clomiphene) for 3 months whereas the control group will just receive the standard regimen for 3 months. Sperm motility, morphology, and count will be assessed at baseline and 3 months later as a primary outcome. Only analysts are blinded in this study

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016081320441N5
Registration date: 2016-09-10, 1395/06/20
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-09-10, 1395/06/20
Registrant information
Name
Farzaneh Foroughinia
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3635 9357
Email address
foroughinia@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences, international branch
Expected recruitment start date
2016-01-24, 1394/11/04
Expected recruitment end date
2017-03-19, 1395/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Spirulina microalgae on Semen Parameters in Men with Idiopathic Infertility
Public title
Effect of Spirulina microalgae on Semen Parameters in Men with Infertility
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patient with idiopathic infertility (abnormal sperm motility and morphology based on WHO index); evidence of wife fertility; age 20-40 year. Exclusion criteria: medical situation or surgery that can cause infertility; previous history of chemotherapy; history of varicocel of cryptorchidism; BMI 30kg/m2 or greater; alcohol, drugs or other substance abuse; treatment with androgen or anti-androgen drugs; severe kidney insufficiency (serum creatinine greater than 2.0 mg/dl); sever liver insufficiency (serum bilirubin greater than 2.0 mg/dl); azoospermia; treatment with immune-suppressant drugs
Age
From 20 years old to 40 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Zand avenue, ُShiraz, Fars, Iran
City
Shiraz
Postal code
Approval date
2016-01-24, 1394/11/04
Ethics committee reference number
IR.SUMS.REC.1394.187

Health conditions studied

1

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

Primary outcomes

1

Description
Sperm motility
Timepoint
Baseline and 3 months later
Method of measurement
Laboratory analysis

2

Description
Sperm morphology
Timepoint
Baseline and 3 months later
Method of measurement
Laboratory analysis

3

Description
Sperm count
Timepoint
Baseline and 3 months later
Method of measurement
Laboratory analysis

Secondary outcomes

empty

Intervention groups

1

Description
Intervention: administration of 2 g spirulina daily plus standard regimen for the treatment of idiopathic male infertility for 3 months
Category
Treatment - Drugs

2

Description
Control: just standard regimen for treatment of idiopathic male infertility ( L-carnitine, zinc sulfate, clomiphene 50mg/day) for 3 months
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Faghihi hospital
Full name of responsible person
Farzaneh Foroughinia
Street address
Faghihi hospital, Zand Avenue, Shiraz, Fars, Iran
City
Shiraz

2

Recruitment center
Name of recruitment center
Motahari polyclinic
Full name of responsible person
Farzaneh Foroughinia
Street address
Motahari polyclinic, Zand Avenue, Shiraz, Fars, Iran
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences, international branch
Full name of responsible person
Ali Poostforoosh Fard
Street address
Vice Chancellor of Research, Shiraz University of Medical Sciences, Zand avenue, ُShiraz, Fars, Iran
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences, international branch
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Farzaneh Foroughinia
Position
Assistant profesoor
Other areas of specialty/work
Street address
Faculty of pharmacy, Shiraz University of Medical Sciences
City
Shiraz
Postal code
Phone
+98 917 713 6095
Fax
Email
farzanehforoughinia@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Farzaneh Foroughinia
Position
Assistant professor
Other areas of specialty/work
Street address
Faculty of pharmacy, Shiraz University of Medical Sciences
City
Shiraz
Postal code
Phone
+98 917 713 6095
Fax
Email
farzanehforoughinia@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Farzaneh Foroughinia
Position
Assistant profesor
Other areas of specialty/work
Street address
Faculty of pharmacy, Shiraz University of Medical Sciences
City
Shiraz
Postal code
Phone
+98 917 713 6095
Fax
Email
farzanehforoughinia@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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