Objective: The aim of this study is to evaluate the efficacy of Iranian herbal remedy on spermogram parameter in men with idiopathic infertility.
Design: This study is a clinical trial without control group and placebo, in the form of before_after analysis.
Setting and conduct: The 40 infertile patients with idiopathic oligo-astheno-teratozoospermia according to inclusion and exclusion criteria intake drug dose.
Participants including major eligibility criteria:
Inclusion criteria: 1. Men 20-45 years; 2. infertility for at least one year; 3. oligo-astheno-teratozoospermia unexplained according to WHO.
Exclusion criteria: 1. The history of intake chemotherapy, corticosteroid, anticoagulation, testosterone, antiandrogen; 2. The incidence of severe cases oligospermia; 3. infections, genital anatomical abnormalities, chromosomal abnormalities, history of surgery on the genital tract, exposure to toxins;
4.Alcohol or drug abuse; 5. systemic diseases.
Intervention: Drug dosage recommended to patients. Therapeutic dose is 5 g from remedy BID for 3 months, and after 3 months samples tested and new spermogram be analyzed, and the results will be compared.
Main out come: Improve sperm concentration or sperm motility or normal morphology is important.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015100624377N1
Registration date:2015-11-06, 1394/08/15
Registration timing:registered_while_recruiting
Last update:
Update count:2
Registration date
2015-11-06, 1394/08/15
Registrant information
Name
Somaye Mahroozade
Name of organization / entity
Iranian Traditional Medicine schoo, Tehran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 2264 1913
Email address
mahrouzs891@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Tehran University of Medical Sciences, Iranian Traditional Medicine fac
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2016-02-04, 1394/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of one of the Iranian Traditional Remedy(lobub morakab) in spermogram parameter in Idiopathic Male Infertility in Imam Khomeyni hospital
Public title
The efficacy of one of the Iranian Traditional Remedy on spermogram in infertile men
Purpose
Treatment
Inclusion/Exclusion criteria
Men referring to Imam Khomeini hospital infertility clinic by urologist had been diagnosed with idiopathic infertility, according to inclusion and exclusion criteria were enrolled in the study. Inclusion criteria: 1. Men 20-45 years; 2.Infertility for at least one year; 3. Oligo-astheno-teratozoospermia unexplained according to WHO: Sperm concentrations below 20 million per milliliter; 5.Motile sperm less than 50%; 6. The normal morphology less than 30%;
Exclusion criteria:
1. History of taking chemotherapy, Corticosteroid, Anticoagulation,Testosterone, Antiandrogen; 2. The incidence of severe cases oligospermia (sperm concentration less than one million per milliliter); 3. infections, genital anatomical abnormalities, chromosomal abnormalities, history of surgery on the genital tract, exposure to toxins; 4.Alcohol or drug abuse; 5. Systemic diseases (cancer, thyroid disease, liver and gall bladder, renal failure, etc.); 7. The reluctance of patients to continue; 8. Make any side effects from medication
Age
From 20 years old to 45 years old
Gender
Male
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The ethics committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences,Qods St, Keshavarz Blvd
City
Tehran
Postal code
Approval date
2015-09-27, 1394/07/05
Ethics committee reference number
IR.TUMS.REC.1394.847
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N46
ICD-10 code description
Diseases of male genital organs,Male infertility,
Primary outcomes
1
Description
Semen volume
Timepoint
At the begining of the trial, 3 months after end of the drug
Method of measurement
Semen analysis
2
Description
Sperm count
Timepoint
At the begining of the trial, 3 months after end of the drug
Method of measurement
Sperm analysis
3
Description
Sperm motility
Timepoint
At the begining of the trial, 3months after end of the drug
Method of measurement
Semen analysis
4
Description
Normal morphology
Timepoint
At the begining of the trial, 3months after end of the dru
Method of measurement
Semen analysis
Secondary outcomes
1
Description
Fertility
Timepoint
After treatment
Method of measurement
Partner pregnancy
Intervention groups
1
Description
Remedy recommended 5 g, twice a day with milk for 3 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini hospital
Full name of responsible person
Somaye Mahroozade
Street address
Imam Khomeini hospital, Keshavarz Blvd.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research,Tehran University of Medical Sciences, Iranian Traditional Medicine fac
Full name of responsible person
Dr.Rahimi
Street address
Traditional Medicine Faculty, No 3, West Jamali St, Heravi Sq.
City
Tehran
Grant name
پایان نامه
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research,Tehran University of Medical Sciences, Iranian Traditional Medicine fac
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences.
Full name of responsible person
Mrs Akbari
Street address
Tehran university of Medical Sciense, Qods St, Keshavarz Blvd
City
Tehran
Grant name
طرح تحقیقاتی
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tehran University of Medical Sciences.
Proportion provided by this source
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
Traditional Medicine Faculty of Tehran Medical University.
Full name of responsible person
Somaye Mahroozade
Position
PhD coarse
Other areas of specialty/work
Street address
Imam Khomeini Hospital, Traditional Medicine clinic, Keshavarz Blvd.
City
Tehran
Postal code
1419733141
Phone
+98 21 2264 1913
Fax
Email
dr.mahroozade@gmail.com; mahrouzs891@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Medical Faculty of Tehran University of Medical Sciences