Sexual AbstinenceNCT02683057
Influence of Physical Exercise on Semen Quality
An observational study of Sexual Abstinence, run by IVI Bilbao at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sexual Abstinence
- What is being tested?
- International Physical Activity Questionnaire (IPAQ)
- How many people
- 207 participants
- Where
- 1 siteSpain
- Study dates
- May 2015to Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
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
Who may be able to join
- Appear as sperm donor
- Age between 18-35 years
- First sperm donation
- Sexual abstinence 3-5 days
- Having signed informed consent
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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
- Conditions
- Sexual Abstinence
- Being tested
- International Physical Activity Questionnaire (IPAQ)
- Medical subject headings
- Sexual Abstinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
International Physical Activity Questionnaire (IPAQ)Other
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)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: 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. Receives: Other: International Physical Activity Questionnaire (IPAQ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (1)
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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2016 (estimated)
- Study startMay 2015
- Primary completionMar 2019
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual AbstinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- IVI Bilbao
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Valenciano de Infertilidad, IVI VALENCIA
- Responsible party
- Sponsor
- Investigators
- Roberto Matorras, Principal investigator, IVI Bilbao
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02683057
- Sponsor's protocol ID
- 1411-BIO-080-RM
- Status last verified
- Jun 2021
- First submitted
- 25 Jan 2016
- Last updated
- 7 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Physical Exercise on Semen Quality
- ClinicalTrials.gov ID
- NCT02683057
- Acronym / sponsor ID
- 1411-BIO-080-RM
- Conditions
- Sexual Abstinence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- IVI BilbaoUniversity, hospital or other
- Collaborators
- Instituto Valenciano de Infertilidad, IVI VALENCIA
- Study start
- May 2015 (actual)
- Primary completion
- Mar 2019 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 17 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IPAQ HIgh | – | Other: International Physical Activity Questionnaire (IPAQ)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 |
| IPAQ Moderate | – | Other: International Physical Activity Questionnaire (IPAQ)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. |
| IPAQ Low | – | Other: International Physical Activity Questionnaire (IPAQ)IPAQ quantifying the activity physical according Insufficient physical activity: Individuals who can not put on the criteria of the above categories. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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
Key inclusion criteria (5 listed)
- Appear as sperm donor
- Age between 18-35 years
- First sperm donation
- Sexual abstinence 3-5 days
- Having signed informed consent
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Other | IPAQ HIgh, IPAQ Low, IPAQ Moderate |
Primary outcome
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)
Time frame: 2 years
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.
1 secondary outcome
Existence of confounding factors associated with physical activity
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2021.
Related trials for Sexual Abstinence
RecruitingPhase 1
Sex Differences in the Response to Abstinence From Alcohol.
Alcohol Use Disorder
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
Recruiting
Quitting Matters Human Immunodeficiency Virus Hybrid Trial
Tobacco, Tobacco Abstinence
RecruitingObservational study
Pornography Abstinence and Nocturnal Erections in Adult Men
Erection; Incomplete
Enrolling by invitationPhase 4
Botswana Smoking and Abstinence Reinforcement Trial
Smoking Cessation, Hiv
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roberto Matorras principal investigator
IVI Bilbao
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sexual Abstinence, run by IVI Bilbao at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2021.