Infertility is one of the effective and serious problems in all of communities. The range of its frequency has been increased with respect to changes in diets and lack of physical activity in recent years. Nowadays, this hypothesis arouses that weight loss through changes in diet and life style, can case improvement in infertility which resulted from obesity and relative metabolic disorders. This study carried out for assessment the effect of weight loss through a regular diet (which is accompanied by increase of physical activities) on male fertility parameters. In this study 50 qualified person (with respect to conditions which are mentioned in inclusion criteria and after the omission of some person with respect to exclusion criteria) were selected and primary information, serological experiments (FSH- LH- TSH- PRC- Test- TG- Cholesterol- LDL- HDL), and sperm analysis according to WHO standards which 5 days have left from the last sperm discharge, will be carried out in two times (before and after diet). A suitable diet along with enough physical activity is considered for all of patients. At the end of 6 month, due to investigation of effectiveness of intervention in improvement of male semen parameters, laboratory assessment will be measured again.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138902051760N5
Registration date:2010-11-04, 1389/08/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-11-04, 1389/08/13
Registrant information
Name
Nargess Gholizadeh Pasha
Name of organization / entity
Fatemehzahra Infertility Reproductive Health Research Center, Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3236 2282
Email address
zahra@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology, Babol University of Medical Sciences
Expected recruitment start date
2010-07-23, 1389/05/01
Expected recruitment end date
2011-02-20, 1389/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of weight loss on reproductive parameters in infertile men
Public title
Effect of weight loss on reproductive parameters in infertile men
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Infertile men with BMI>25 who have passed more than one year of regular Coitus. Exclusion criteria: Men who are addicted to Cigarette, alcohol and narcotic; Men who have chronic illness during last three weak; Men who uses certain drugs; Men who suffer from varicocele, Obstruction of vas deferens, absence of Testis or any organic change in reproductive system and also azoospermic or severe oligospermic patients (below 5 million sperm count).
Age
From 25 years old to 45 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
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 Babol University of Medical Sciences
Street address
Gangafroz Avenue
City
Babol
Postal code
Approval date
2010-07-12, 1389/04/21
Ethics committee reference number
1016
Health conditions studied
1
Description of health condition studied
Body Mass Index
ICD-10 code
E66
ICD-10 code description
Obesity
2
Description of health condition studied
Male infertility
ICD-10 code
N46
ICD-10 code description
Male infertility
Primary outcomes
1
Description
Weight Loss
Timepoint
Monthly for six months
Method of measurement
BMI Value
2
Description
Sperm Count
Timepoint
After six months
Method of measurement
Laboratory
3
Description
Sperm Motility
Timepoint
After six months
Method of measurement
Laboratory
4
Description
Sperm morphology
Timepoint
After six months
Method of measurement
Laboratory
5
Description
Liquid semen Volume
Timepoint
After six months
Method of measurement
Laboratory
Secondary outcomes
1
Description
Effect of weight loss on serum hormonal parameters (FSH-LH-TEST- HDL- LDL, ...) and test the semen
Timepoint
6 months
Method of measurement
Laboratory (hormone measurement techniques appropriate for each test)
Intervention groups
1
Description
Appropriate diet for weight loss (with allocation of food calories 500kcal/day less than the recommended standard for each individual based on age and physical activity), Increase physical activity (daily one hour daily exercise more than average, including: walking fast, soft exercise and ...)
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemehzahra Fertility & reproductive Health Reseach Center
Full name of responsible person
Marmar Firoozpour Bandepey
Street address
Noshirvani street
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology, Babol University of Medical Sciences
Full name of responsible person
Dr. Ali Bijani
Street address
Gangafroz Avenue
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research and Technology, Babol University of Medical Sciences
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
Fatemehzahra Fertility & reproductive Health Reseach Center
Full name of responsible person
Nargess Gholizadeh Pasha
Position
M.A/Responsible for Public Affairs Research Center
Other areas of specialty/work
Street address
Fatemehzahra Fertility & reproductive Health Reseach Center, Noshirvani street
City
Babol
Postal code
Phone
+98 11 1227 4881
Fax
+98 11 1227 4880
Email
ngh_pa@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Fatemehzahra Fertility & reproductive Health Reseach Center
Full name of responsible person
Dr. mohammad-Reza Aghajani Mir
Position
Urology specialist
Other areas of specialty/work
Street address
Fatemehzahra Fertility & reproductive Health Reseach Center - noshirvani street
City
Babol
Postal code
Phone
+98 11 1227 4881
Fax
+98 11 1227 4880
Email
aghajanimir@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Fatemehzahra Fertility & reproductive Health Reseach Center
Full name of responsible person
Nargess Gholizadeh Pasha
Position
Responsible for Public Affairs Research Center
Other areas of specialty/work
Street address
Fatemehzahra Fertility & reproductive Health Reseach Center - noshirvani steert
City
Babol
Postal code
4719173716
Phone
+98 11 1227 4881
Fax
+98 11 1227 4880
Email
zahra@mubabol.ac.ir , ngh_pa@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)