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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02683057
Other study ID # 1411-BIO-080-RM
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 2015
Est. completion date December 2020

Study information

Verified date June 2021
Source IVI Bilbao
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Our study addresses a previously selected population or by physical activity but not for semen quality semen donor candidates donation program within the clinic. Total physical activity was analyzed according to the universally accepted international physical activity questionnaire (IPAQ) The existence of confounding factors associated She purge age, snuff, weight, BMI, alcohol, drugs, type of sport and associated blood parameters determinations will be made to exercise.


Description:

The level of physical activity recommended great unknown and its influence from the therapeutic point of view to improve semen quality. For it will be held: - 3 groups of physical activity are established, according to their score in the IPAQ: High, minimum of physical activity between > 1500 MET week Moderate: minimum of physical activity of between 600- 1500 MET week Low : until < 600 MET week - Implementation of a double analysis: Seminal and hormonal - Standardization of confounding factors associated with the individual


Recruitment information / eligibility

Status Completed
Enrollment 207
Est. completion date December 2020
Est. primary completion date March 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria: - Appear as sperm donor - Age between 18-35 years - First sperm donation - Sexual abstinence 3-5 days - Having signed informed consent Exclusion Criteria: -

Study Design


Related Conditions & MeSH terms


Intervention

Other:
International Physical Activity Questionnaire (IPAQ)
all candidates for sperm donors clinic IVI IVI Bilbao and Valencia were will provide the international physical activity questionnaire (IPAQ) attached to analyze the total physical activity. This will be self-completed questionnaire beforeSperm donation. (Appendix 1) Age, snuff, weight, BMI, alcohol, drug use and the type of sport that practices will be analyzed: Additionally a tab for each donor collecting the existence of associated factors be drawn. (Appendix 2)

Locations

Country Name City State
Spain IVI Bilbao Leioa Vizcaya

Sponsors (2)

Lead Sponsor Collaborator
IVI Bilbao Instituto Valenciano de Infertilidad, IVI VALENCIA

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Ascertain the influence of physical activity in sperm quality to candidates for sperm donors in the donation program according to the universally accepted questionnaire International physical activity (IPAQ) Semen parameters will be evaluated according to WHO criteria blinded on clinical and data analyst.
International Physical Activity Questionnaire (IPAQ) offers before sperm donation quantifying the activity "walk", "activities of moderate intensity" and "vigorous intensity activities" assigned to each activity about energy requirements defined in METs, being multiples of the rate of metabolic rate equivalent to kilocalories for a 60 kg.
The median and interquartile range (between Q1 and Q3) is calculated for walking (W), activities of moderate intensity (M), activities of vigorous intensity (V) and a combined result of total physical activity. All results must be expressed as continuous METminutos / week.
2 years
Secondary Existence of confounding factors associated with physical activity The existence of confounding factors such as age, tobacco, weight, BMI, alcohol, drugs, type of sport will be cleaned and blood parameters associated with physical activity will be defined.
A data tab/sheet for each donor was made . The existence of related factors such as age, tobacco, weight, BMI, alcohol, drug and the type of sport exercised were been analysed.
It categorizes the population into quartiles depending on their activity and determine which is which is associated with a better seminal quality the same debugging is made confounding previously mentioned.
multivariate analysis to determine the correlation between physical activity and sperm parameters
2 years
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