NCT02683057

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
207

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 25, 2016

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 17, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

June 7, 2021

Status Verified

June 1, 2021

Enrollment Period

3.8 years

First QC Date

January 25, 2016

Last Update Submit

June 4, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Existence of confounding factors associated with physical activity

    2 years

Study Arms (3)

IPAQ HIgh

Excessive physical activity:IPAQ quantifying the activity physical according vigorous intensity activities at least 3 days per week adding a minimum total physical activity of at least 1500MET-minutes / week or 7 or more days any combination of walking, moderate intensity or vigorous intensity activities a total minimum of physical activity of at least 3,000 MET-minutes / week

Other: International Physical Activity Questionnaire (IPAQ)

IPAQ Moderate

Ideal Physical activity: IPAQ quantifying the activity physical according 3 days or more of vigorous intensity physical activity at least 20 minutes per day or 5 or more days of moderate intensity and / or walk at least 30 minutes per day or 5 or more days of any combination of walking, moderate-intensity activity and activity vigorous intensity for a total minimum of physical activity of at least 600 MET-minutes / week.

Other: International Physical Activity Questionnaire (IPAQ)

IPAQ Low

IPAQ quantifying the activity physical according Insufficient physical activity: Individuals who can not put on the criteria of the above categories.

Other: International Physical Activity Questionnaire (IPAQ)

Interventions

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)

IPAQ HIghIPAQ LowIPAQ Moderate

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Candidates for sperm donors in the donation program which aims clinic It is performed in 432 cases. For that, our study addresses a population previously selected either by physical activity or by semen quality

You may qualify if:

  • Appear as sperm donor
  • Age between 18-35 years
  • First sperm donation
  • Sexual abstinence 3-5 days
  • Having signed informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IVI Bilbao

Leioa, Vizcaya, 48011, Spain

Location

MeSH Terms

Conditions

Sexual Abstinence

Condition Hierarchy (Ancestors)

Sexual BehaviorBehavior

Study Officials

  • Roberto Matorras

    IVI Bilbao

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2016

First Posted

February 17, 2016

Study Start

May 1, 2015

Primary Completion

March 1, 2019

Study Completion

December 1, 2020

Last Updated

June 7, 2021

Record last verified: 2021-06

Locations